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THE MINISTRY OF
HEALTH OF VIETNAM
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THE SOCIALIST
REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No. 04/VBHN-BYT
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Hanoi, June 03,
2024
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DECREE
PRESCRIBING MEDICAL
DEVICE MANAGEMENT [1]
The Government’s Decree No. 98/2021/ND-CP dated
November 08, 2021 prescribing medical device management[2], coming into force from January 01,
2022, is amended by:
The Government’s Decree No. 07/2023/ND-CP dated
March 03, 2023 providing amendments to the Government’s Decree No.
98/2021/ND-CP dated November 08, 2021 prescribing medical device management[3], coming into force
from March 03, 2023.
The Government’s Decree No. 96/2023/ND-CP dated
December 30, 2023 on elaboration of the Law on Medical Examination and
Treatment, coming into force from January 01, 2024.
Pursuant to the Law on Government Organization
dated June 19, 2015; the Law on Amendments to the Law on Government
Organization and the Law on Local Government Organization dated November 22,
2019;
Pursuant to the Law on Investment dated June 17,
2020;
At the request of the Minister of Health of
Vietnam;
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Chapter I
GENERAL PROVISIONS
Article 1. Scope
1. This Decree deals with the management of medical
devices [5],
including: classification of medical devices[6]; manufacture, placement on the market,
trading, import, export and provision of services related to medical devices[7]; medical device
information and advertising[8];
management of prices of medical devices, and management[9] and use of medical devices[10] in health
facilities.
2. This Decree does not apply to:
a) Ingredients and semi-finished products used for
manufacture of medical devices[11],
except raw materials containing narcotic substances and precursors;
b) Raw materials for manufacture of medical devices
[12], including
samples of blood, serum, plasma, urine, fecal, body fluids or other human
materials that are subject to biosafety requirements upon import/export as
prescribed by law;
c) Medical gas;
d) Medical device accessories[13];
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Article 2. Definitions
1. “medical device” [14] means any instrument, implant, apparatus,
material, in-vitro reagent or calibrator, or software that meets all of the
following requirements:
a) It is intended, by the product owner [15], to be used,
whether alone or in combination, for human beings for the purpose of one or
more of the following:
- diagnosis, prevention, monitoring, treatment or
alleviation of disease, or compensation for an injury or trauma;
- investigation, replacement, modification or
support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception,
- disinfection of medical devices [16];
- providing information serving diagnosis,
monitoring or treatment through examination of specimens derived from the human
body.
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2. “in vitro diagnostic (IVD) medical device” [17] means a reagent,
calibrator, control material, instrument, apparatus, equipment or system or
other product, whether used alone or in combination, intended by the product
owner, to be used in vitro for the examination of specimens derived from the
human body.
3. “personalized medical device” [18] means a medical device[19] that is specifically made in
accordance with a duly qualified medical practitioner’s written prescription,
which gives, under his responsibility, specific design characteristics and
intended for the sole use of a particular individual.
4. “accessory” means an article that is intended
specifically by its product owner[20]
to be used together with a particular medical device[21] to enable or assist that device to be
used in accordance with its intended purpose.
5. “product owner” [22] means any organization or person that:
a) supplies the medical device[23] under its/his own name, or under any
trademark, design, trade name or other name or mark owned or controlled by
it/him; and
b) is responsible for designing, manufacturing,
assembling, processing, labeling, packaging, refurbishing or modifying the
medical device[24],
or for assigning to it[25]
a purpose.
Article 3. Principles of management of medical
devices [26]
1. The quality, safety and efficacy of the medical
device[27] must be
verified.
2. Adequate, accurate and timely information about specifications
and intended purpose of the medical device [28] and potential risks to the user must
be provided.
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4. Medical devices[30] shall be managed in accordance with
risk classification rules and relevant national technical regulations and/or
national standards issued or recognized by competent regulatory authorities or
announced standards applied by organizations/individuals in accordance with
regulations of law.
5. Medical devices[31] that are measuring devices or
radiation equipment must be managed in accordance with regulations of the law
on measurement, the law on atomic energy and regulations herein.
6. Chemicals and preparations intended solely for
disinfection of medical devices[32]
shall be managed in accordance with regulations herein. Chemicals and
preparations intended for other purposes, in addition to the disinfection of
medical devices[33],
shall be managed in accordance with regulations of law on insecticidal and
germicidal chemicals and preparations for medical and household use.
7. Medical devices[34], raw materials or ingredients used for
manufacturing of medical devices[35],
and substances for external quality assessment that contain narcotic substances
and precursors must be managed in accordance with regulations of law on drug
control, if they are imported or exported, and regulations herein.
8. Regulations on classification, issuance of
registration number, and eligibility requirements for trading of medical
devices laid down herein shall not apply to:
a) Software used for medical devices[36];
b) Medical devices[37] that are traded as normal goods and
imported as gifts or presents given to individuals or organizations other than
health facilities.
Chapter II
CLASSIFICATION OF MEDICAL DEVICES [38]
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Medical devices[40] shall be classified into the following
4 classes according to their levels of potential risks related to their designs
and manufacture[41]:
1. Class-A medical devices[42]: medical devices[43] with low risk.
2. Class-B medical devices[44]: medical devices[45] with low to medium risk.
3. Class-C medical devices[46]: medical devices[47] with medium to high risk.
4. Class-D[48]: medical devices[49] with the highest possible risk.
Article 5. Classification rules for medical
devices[50]
1. The classification of medical devices[51] must be carried
out in accordance with risk classification rules.
2. In the event that a medical device[52] only has one
intended purpose which is assigned into two or more risk levels, that medical
device shall be assigned into the class representing the highest risk
level.
3. In the event that a medical device[53] has multiple
intended purposes and each of which represents various risk levels, that
medical device shall be assigned into the class representing the highest risk
level.
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IVD medical devices[57] that are equipment or systems used in
testing process and reagents, titrants, calibrators or control materials may be
assigned into various risk levels but assigned into the class representing the
highest level of risks posed by the final purpose of that medical device[58] as a whole. IVD medical
devices[59] that
are other products used in or supporting testing process may be separately
assigned into risk levels.
5. The Minister of Health of Vietnam shall provide
detailed guidelines on classification of medical devices[60] in accordance with ASEAN’s treaties on
classification of medical devices[61]
to which Vietnam is a signatory.
6. The classification of medical devices[62] must be carried
out by the classification body whose name is specified in the declaration of
applied standards or certificate of registration of medical device.
Article 6. Cancellation of classification
results of medical devices [63]
1. Classification results of medical devices[64] shall be
cancelled in the following cases:
a) The incorrect classification result reduces the
level of risk of the medical device[65];
b) The record of classification results is found
fraudulent.
2. Procedures for cancellation:
a) Within 01 working day from the day on which a
conclusion mentioned in Clause 1 of this Article is given, the Ministry of
Health shall issue a decision to cancel classification result which request the
classification body to implement remedial measures (if any) and remove the
cancelled medical device [66]
classification result from the Portal on management of medical devices[67].
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b) After receiving the decision to cancel
classification result, the classification body shall cancel all classification
results specified in the decision and implement remedial measures against its
violations (if any).
c) After receiving the decision to cancel
classification result, the authority that has received the application for
declaration of applied standards or application for registration number (hereinafter
referred to as “application for registration number”) shall review the
registration numbers issued, and follow procedures for revoking the
registration numbers of medical devices[70] that have been issued using classification
results specified in the Ministry of Health’s decision to cancel classification
results of such medical devices[71].
Article 7. Handling of medical devices[72] whose
classification results are cancelled
1. In case a medical device[73] whose classification result is
cancelled has not been granted the registration number:
a) The applicant for registration number shall send
a written request to the receiving authority to suspend procedures for issuance
of registration number.
b) After receiving the written request mentioned in
Point a of this Clause or the decision to cancel medical device[74] classification result, the receiving
authority shall refuse to issue the registration number.
2. In case a medical device[75] whose classification result is
cancelled has been granted the registration number but has not been granted
customs clearance:
a) The registration number holder shall stop
following procedures for customs clearance, request the checkpoint customs
authority to suspend procedures for customs clearance, and request the
registration number issuer to revoke the issued registration number.
b) After receiving the written request from the
registration number holder or the decision to cancel medical device[76] classification
result, the customs authority shall suspend procedures for customs clearance,
and the registration number issuer shall follow procedures to revoke the issued
registration number.
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a) The registration number holder shall:
- Stop placing the medical device[78] granted the registration number using
the classification result that has been cancelled on the market, and adopt measures
to recall it[79];
- Send a report to the customs authority that
granted customs clearance in which the quantity of medical device[80] granted customs
clearance must be specified, and do not follow procedures for import of the
following shipments until the relevant medical device[81] is granted a new registration number
using the correct classification result;
- Send a report to the registration number issuer
specifying the quantity of medical device[82] granted customs clearance and the sale
contracts (if any);
- Reapply for the registration number.
b) After receiving the registration number holder’s
written request or the decision to cancel classification result of the medical
device[83]:
- The customs authority shall refuse to grant
customs clearance;
- The registration number issuer shall revoke the
issued registration number.
4. If the medical device[84] has been sold to health facilities:
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- Send a report to the registration number issuer
specifying the quantity of medical device[85] sold to health facilities;
- Send written notices to health facilities that
purchased the medical device[86].
b) If the medical device[87] granted the registration number using
incorrect classification result does not pose threats to patients’ heath,
health facilities may keep using the medical device[88] and the registration number holder
shall supplement the documents about registration of the medical device[89] after a new
registration number is granted.
c) If the medical device[90] granted the registration number using
incorrect classification result is found to pose threats to patients’ heath,
health facilities shall stop using the medical device[91] and the registration number holder
shall implement necessary measures for ensuring normal operation of such health
facilities.
Chapter III
MANUFACTURE OF MEDICAL DEVICES[92]
Article 8. Requirements for quality control by
medical device[93]
manufacturer
1. The manufacturer’s quality control system must
comply with ISO 13485.
2. A manufacturer of the medical device[94] that contains
narcotic substances and precursors shall, in addition to the requirements laid
down in Clause 1 of this Article, also meet the following requirements:
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b) Medical devices[96] and raw materials containing narcotic
substances and precursors must be safely stored in a separate area or
warehouse.
Article 9. Application for declaration of
eligibility for manufacture of medical devices[97]
An application for declaration of eligibility for
manufacture of medical devices[98]
includes:
1. The declaration of eligibility for manufacture
of medical devices.
2. Certificate of conformity with ISO 13485 quality
control standards issued by the conformity assessment body in accordance with regulations
of law.
3. The documents proving the satisfaction of
eligibility requirements specified in Clause 2 Article 8 of this Decree.
Article 10. Requirements for application for
declaration of eligibility for manufacture of medical devices[99]
1. A set of application for declaration of
eligibility for manufacture of medical devices[100] shall be prepared. To be specific:
a) Documents included in the application must be
clearly printed and arranged in the order prescribed in Article 9 of this
Decree; space must be provided between content parts in a document; the
application must have covers and a list of documents.
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2. Requirements for some documents in an
application for declaration of eligibility for manufacture of medical devices:
a) The original or certified true copy or copy
bearing the applicant’s certification of the Certificate of conformity with
quality control standards.
b) The originals bearing the applicant’s
certification of documents proving its satisfaction of eligibility requirements
as set out in Clause 2 Article 8 of this Decree.
Article 11. Procedures for declaration of
eligibility for manufacture of medical devices[101]
1. Before initiating manufacture of medical devices[102], the medical
device [103]
manufacturer shall submit an application for declaration of eligibility for
manufacture of medical devices to the Department of Health of province where
its factory is located (the manufacturer’s factory is specified in the
certificate of quality control system). Where there are multiple factories
located in different provinces, application for each province shall be
submitted.
2. After receiving the application (including
application fee receipt as prescribed by the Ministry of Finance), the
Department of Health of province where the medical device[104] manufacturing factory is located
shall publish on the Portal on management of medical devices[105] all information about and application
for declaration of eligibility for manufacture of medical devices[106].
3. During its operation, the manufacturer shall
prepare a notice of changes which is accompanied by supporting documents for such
changes, and update such documents to its application for declaration of
eligibility for manufacture of medical devices published on Portal on
management of medical devices[107]
within 03 working days from the occurrence of such changes.
Chapter IV
CLINICAL TRIALS FOR MEDICAL DEVICES[108]
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1. A clinical trial for medical devices other than
in vitro diagnostic (IVD) medical devices has the following phases:
a) Phase 1: preliminary study on the safety of
medical device for patients and its usability for medical practitioners and
healthcare workers.
b) Phase 2: confirmatory study to ascertain and
establish evidence for the safety and efficacy of medical device;
c) Phase 3: post-market study which is conducted
after the medical device has been placed on market to collect additional
evidences on the safety and efficacy of the medical device when used at the
request of competent authorities.
2. A clinical trial for IVD medical devices has the
following phases:
a) Phase 1: evaluation of clinical performance of
the IVD medical device;
b) Phase 2: post-market study which is conducted
after the IVD medical device has been placed on market to collect additional
evidences on the safety and efficacy of the IVD medical device when used at the
request of a competent authority.
Article 13. Exemption from clinical trials or
some clinical trial phases before applying for registration number for medical
devices[110]
1. The following medical devices will be exempt
from clinical trials:
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b) Class-C or Class-D medical devices for which
registration number has been granted by the Ministry of Health of Vietnam or
competent authorities of foreign countries.
2. Class-C or Class-D medical devices which are
domestically manufactured and are not IVD medical devices will be exempt from the
clinical trial Phase 1 if the following requirements are met:
a) The medical device has been manufactured
employing a transferred technology which has been used in the manufacturing of
a medical device granted registration number by a competent authority, unless
such registration number has been revoked;
b) The subject medical device has the same
indications for use as the one which has been granted registration number by a
competent authority as prescribed in point a of this clause.
3. The exemption from clinical trials or one or
some clinical trial phases granted to medical devices used to serve urgent
needs for national defense and security, epidemic prevention and control or
disaster recovery shall be subject to the Ministry of Health of Vietnam’s
decision.
Article 14. Requirements for medical devices
undergoing clinical trial[111]
1. All legal and technical requirements set out in
documentation requirements for registration of a medical device are met.
2. The investigational medical device must be
labeled as “for clinical trial only - not for any other purposes”. The labeling
of medical devices shall comply with regulations of law on labeling of goods.
Article 15. Eligibility requirements for
institutions conducting medical device clinical trials (hereinafter referred to
as “clinical trial institution”) [112]
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2. It is capable of performing scientific research
function and has its scope of operation conformable with the medical device
subject to the clinical trial.
3. It must be a juridical person whose
organizational structure, personnel and finance are independent from the
organization or individual whose medical device is subject to the clinical
trial.
Article 16. Clinical trial dossier for medical
devices[113]
1. A clinical trial dossier for medical device includes:
an application for approval of clinical trial, application for approval of
changes in clinical trial, and application for approval of clinical trial
results. Components of each application will comply with the provisions of
Article 17 of this Decree.
2. Requirements for documents:
a) Documents included in the clinical trial dossier
for a medical device must be made in Vietnamese. Documents in a language other
than Vietnamese must be accompanied by their certified Vietnamese translations.
b) Documents issued by foreign regulatory
authorities must bear consular legalization made in accordance with regulations
of law on consular legalization, unless such consular legalization procedures
are exempted in accordance with regulations of law.
Article 17. Components of a clinical trial
dossier for medical device[114]
1. An application for approval of clinical trial
includes:
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b) An application form made by the clinical trial
institution.
c) A competent authority’s written request in
respect of the medical device which must undergo the clinical trial phase 3 or
the IVD medical device which must undergo the clinical trial phase 2.
d) Documents on the medical device subject to the
clinical trial, including:
- Description of the product (general information
about the medical device subject to the clinical trial, including: name,
characteristics, uses, indications, contraindications, technical specifications
and other relevant information);
- Documents on preclinical trial on the
investigational medical device, including: study report on the safety and
efficacy of the medical device, recommendations for use and storage of the
medical device, and study reports on the stability and analytical performance
(of IVD medical device) which have been appraised and certified to be
satisfactory by the Expert Council of the clinical trial institution or the
institution conducting preclinical trial vested with certification task by the
Ministry of Health of Vietnam;
- Documents on the clinical trial phases before the
requested phase.
dd) Legal documents, including:
- Information on the owner and manufacturer of the
medical device, manufacturing process;
- Technical file of the medical device;
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- Assessment report certifying that the medical
device is conformable with technical standards provided by a qualified
conformity assessment body as prescribed by law or quality assessment
certificate issued by a competent authority of Vietnam;
- The approved user manual, if the medical device
undergoes the clinical trial phase 3;
- Certificates of consent given by institutions
participating in the trial;
- The clinical trial agreement signed by and
between the authority, organization or individual whose medical device is
subject to the clinical trial and the clinical trial institution; the research
support agreement signed by and between the organization or individual whose
medical device is subject to the clinical trial and the sponsor (if any).
e) Scientific documents, including:
- Description of the medical device clinical trial;
- Case Report Form (CRF);
- Informed consent forms given by the clinical
trial participants.
g) Administrative documents:
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- A record of scientific and ethical assessment
prepared by the internal Research Ethics Committee;
- Label of the investigational medical device as
prescribed in clause 2 Article 14 of this Decree and its user manual.
2. An application for approval of changes in
clinical trial includes:
a) For changes in administrative documents or
contact information of the clinical trial institution: this institution shall
take charge of reporting such changes to the Ministry of Health of Vietnam for
information consolidation.
b) For replacement of the principal investigator or
the clinical trial institution, the application shall include:
- An application form for approval of changes in
clinical trial;
- Documents proving corresponding changes.
c) For changes other than those specified in points
a and b of this Clause, the application shall include:
- An application form for approval of changes in
clinical trial;
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3. An application for approval of clinical trial
results includes:
a) An application form for approval of clinical
trial results;
b) The copy of the approved clinical trial
protocol;
c) A copy of the decision to approve the clinical
trial;
d) The record of appraisal of clinical trial
results made by the internal Research Ethics Committee;
dd) Report on clinical trial results.
Article 18. Procedures for approving clinical
trial [115]
1. The clinical trial institution shall send an
application for approval of clinical trial directly, online or by post to the
Ministry of Health of Vietnam.
2. The Ministry of Health shall check the validity
of the application within 05 working days from the date of receipt. If the
application is valid, within 02 working days, the Ministry of Health of Vietnam
shall transfer the application to the National Research Ethics Committee for
appraisal and ethical considerations. If the application is invalid, within 02
working days, a written notice providing specific instructions for application
modification shall be given to the applicant.
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3. The National Research Ethics Committee shall
conduct review and ethical consideration of the trial on a periodical basis of
every month.
4. Within 05 working days from the receipt of the
certificate of approval of clinical trial given by the National Research Ethics
Committee and the accompanied application, the Ministry of Health of Vietnam
shall issue a decision to approve clinical trial.
Article 19. Procedures for approving changes in
clinical trial [116]
1. The clinical trial institution shall send an
application for approval of changes in clinical trial directly, online or by
post to the Ministry of Health of Vietnam.
2. The Ministry of Health shall check the validity
of the application within 05 working days from the date of receipt. If the
application is invalid, within 02 working days, the Ministry of Health of
Vietnam shall give a written notice providing specific instructions for
modification until the application is considered valid.
The clinical trial institution shall complete the
application within 60 days from the receipt of the notice. After this period,
procedures for approving changes in clinical trial must be restarted.
3. For changes specified in point b clause 2
Article 17 of this Decree: within 07 working days from the receipt of adequate
and valid application, the Ministry of Health of Vietnam shall issue a decision
to approve changes in clinical trial.
4. For changes specified in point c clause 2
Article 17 of this Decree:
a) If the application is valid, within 02 working
days, the Ministry of Health of Vietnam shall transfer it to the National
Research Ethics Committee for review;
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c) Within 05 working days from the receipt of the
certificate of approval of changes in clinical trial given by the National
Research Ethics Committee and the accompanied application, the Ministry of
Health of Vietnam shall issue a decision to approve changes in clinical trial.
Article 20. Procedures for approving clinical
trial results [117]
1. The clinical trial institution shall send an
application for approval of clinical trial results, which must be made in
Vietnamese, directly, online or by post to the Ministry of Health of Vietnam.
2. The Ministry of Health shall check the validity
of the application within 05 working days from the date of receipt. If the
application is valid, within 02 working days, the Ministry of Health of Vietnam
shall transfer it to the National Research Ethics Committee for review. If the
application is invalid, within 02 working days, the Ministry of Health of
Vietnam shall give a written notice providing specific instructions for
modification to the clinical institution.
The clinical trial institution shall complete the
application within 60 days from the receipt of the notice. After this period,
procedures for approving clinical trial results must be restarted.
3. The National Research Ethics Committee shall
conduct review and ethical consideration of the trial on a periodical basis of
every month.
4. Within 05 working days from the receipt of the
certificate of approval of clinical trial results given by the National
Research Ethics Committee and the accompanied application, the Ministry of
Health of Vietnam shall issue a decision to approve clinical trial results.
Chapter V
PLACEMENT OF MEDICAL DEVICES ON MARKET [118]
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Article 21. Registration number of medical
devices[119]
1. Registration number of a medical device[120] is:
a) The number of declaration of applied standards
of Class-A or Class-B medical device[121];
b) The number of certificate of registration of
Class-C or Class-D medical device[122].
2. [123] Registration number holder is the
organization that declares applied standards for medical devices[124] or is issued
with the certificate of registration of medical devices[125] in accordance with the provisions of
this Decree.
3. Validity of registration number: The medical
device[126]
registration number shall be valid for indefinite term, except cases where a
medical device[127]
registration number is issued according to regulations on issuance of emergency
use registration number for medical devices[128] to serve epidemic prevention and
control, and disaster recovery purposes. Based on the application for issuance
of emergency use registration number for the medical device[129], the Minister of Health shall decide
specific period validity of the issued registration number.
Article 22. Conditions for placement of medical
devices on market[130]
[131]
1. A medical device[132] may be placed on the market if it
meets the following conditions:
a) It has been granted registration number,
marketing authorization number, certificate of registration or import license
in accordance with regulations on management of medical devices[133] or in the cases
specified in Point d Clause 2 Article 76 of this Decree, except the following
cases:
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- The medical device reaches its expiry date;
- The defect that is harmful to users’ health
cannot be repaired as prescribed in Clause 4 Article 34 of this Decree;
- The use of medical device is prohibited by a
regulatory authority.
b) Its label contains adequate information in
accordance with regulations of law on labelling of goods;
c) Instructions for use of the medical device[134] are given in
Vietnamese language;
d) Information about warranty center, conditions
and time for warranty, except disposable medical devices[135] defined by product owners[136] or cases where
there are documents proving that the medical device is not under warranty.
2. If the import license is available as prescribed
in Points a, b, c, d and dd Clause 1 Article 48 of this Decree, the
satisfaction of the condition in Point d Clause 1 of this Article is not
required.
3. If the information specified in Point c and
Point d Clause 1 of this Article is not provided upon the medical device[137] itself, it must
be provided in the form of electronic information for which instructions for
search must be available on the label of the medical device[138].
Article 23. Requirements for declaration of
applied standards or issuance of certificate of registration for medical
devices[139]
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a) The medical device is manufactured domestically
by a manufacturer that has made declaration of eligibility for manufacture of
medical devices[141];
b) If the medical device[142] is imported, it has been manufactured
by a manufacturer that is granted certificate of conformity with ISO 13485 quality
control standards, and permitted to be sold in every country in the world;
c) The medical device comply with national
technical regulations or standards declared by the manufacturer.
2. Applications for declaration of applied
standards or registration of medical devices[143] shall be rejected in the following
cases:
a) The medical device [144] falls in the case specified in Clause
1 Article 37 of this Decree;
b) The medical device[145] is recalled under Clauses 1, 3
Article 38 of this Decree.
3. If a medical device[146] registration number is revoked under
Clause 2 Article 38 of this Decree, an application for declaration of applied
standards or registration of that medical device submitted within 12 months
from the date of the revocation decision shall be rejected.
Article 24. Cases of exemption from requirements
for declaration of applied standards and registration
1. The medical device[147] is used for research, testing,
inspection, experiment, performance evaluation, instruction for use or
modification of medical devices[148]
only.
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3. Unregistered medical devices[150] are imported to serve epidemic
prevention and control, disaster recovery and cannot be replaced by any other
medical devices[151]
sold on the market.
4. Medical devices[152] are manufactured in Vietnam to serve
the purposes of export or display at an overseas trade fair or exhibition only.
Article 25. Requirements for organizations
declaring applied standards or applying for registration number for medical
devices[153]
1. Organizations that declare applied standards or
apply for registration number for medical devices [154] include:
a) Vietnamese enterprises, cooperatives or
household businesses that are product owners [155];
b) Vietnamese enterprises, cooperatives or
household businesses that are authorized by product owners[156];
c) Permanent representative offices in Vietnam of
foreign traders that are product owners[157] or authorized by product owners[158].
2. The organization declaring applied standards or
applying for registration of a medical device[159] must establish and maintain a
warranty center in Vietnam or sign a contract with a qualified organization to
provide warranty for medical devices[160],
except disposable medical devices[161]
as defined by product owners [162]
or cases where there are documents proving that the medical device is not under
warranty.
Where the organization declaring applied standards
or applying for registration of a medical device[163] is the entity prescribed in Point c
Clause 1 of this Article, the product owner[164] must establish and maintain a
warranty center in Vietnam or sign a contract with a qualified organization to
provide warranty for medical devices[165],
except disposable medical devices[166]
as defined by product owners[167]
or cases where there are documents proving that the medical device is not under
warranty.
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Section 2. DECLARATION OF APPLIED STANDARDS FOR
CLASS-A OR CLASS-B MEDICAL DEVICES[169]
Article 26. Application for declaration of
applied standards
An application for declaration of applied standards
for Class-A or Class-B medical device[170] consists of:
1. The declaration of applied standards for Class-A
or Class-B medical device[171].
2. An unexpired certificate of conformity with ISO
13485 quality control standards.
3. The unexpired letter of authorization given by
the product owner[172]
to the organization that applies for declaration of applied standards, except
the case specified in Point a Clause 1 Article 25 of this Decree.
4. The certificate of eligibility to provide
warranty services granted by the product owner[173], except disposable medical devices[174] defined by
product owners[175]
or cases where there are documents proving that the medical device is not under
warranty.
5. A synopsis of technical description of the
medical device[176]
in Vietnamese, accompanied by technical documents describing functions and
specifications of the medical device[177]
issued by the product owner[178].
With regard to in-vitro reagents, calibrators and
control materials, the synopsis of technical description in Vietnamese must be
accompanied by documents on materials and safety of the product, manufacturing
process, pre-clinical and clinical trial reports including stability report.
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With regard to domestically manufactured medical
devices[180], the
assessment record of chemical, physical and microbiological indicators and
other indicators provided by a qualified conformity assessment body in
accordance with regulations of law on conformity assessment is required; if it
is an IVD medical device[181],
certificate of quality assessment issued by a competent authority of Vietnam is
required. The assessment result must be conformable with the standards declared
by the product owner[182].
7. User manual of the medical device[183].
8. Sample of the label for the medical device[184] sold in
Vietnam.
9. An unexpired CFS (for imported medical devices[185]).
Article 27. Requirements for application for
declaration of applied standards
1. 01 set of application for declaration of applied
standards shall be prepared.
2. Requirements for some documents included in the
application:
a) Certificate of conformity with quality control
standards: original copy or certified true copy or copy bearing certification
of the declarant.
If the Certificate of conformity with quality
control standards is not written in English or Vietnamese, it must be
translated into Vietnamese. The Vietnamese translation must be certified as
prescribed by law.
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- For a domestically manufactured medical device[187]: original copy
or certified true copy;
- For an imported medical device[188]: Either the document bearing consular
legalization or the certified true copy thereof is accepted.
c) Certificate of conformity or product standard
sheet provided by the product owner[189]:
original copy or copy bearing certification of the declarant.
If the product standard sheet is not written in
English or Vietnamese, it must be translated into Vietnamese. The Vietnamese
translation must be certified as prescribed by law.
d) User manual of the medical device[190]: Vietnamese
copy bearing certification of the declarant, accompanied by English version
issued by the product owner[191],
in case of imported medical devices[192].
If the user manual is not written in English or Vietnamese, it must be
translated into Vietnamese. The Vietnamese translation must be certified as
prescribed by law.
dd) Sample label: the sample label bearing
certification of the declarant. The sample label must meet requirements laid
down in regulations of law on labeling of goods.
e) CFS: Either the document bearing consular
legalization or the certified true copy thereof is accepted.
If the CFS is not written in English or Vietnamese,
it must be translated into Vietnamese. The Vietnamese translation must be
certified as prescribed by law.
g) Record of chemical, physical and microbiological
indicators and other indicators provided by a qualified conformity assessment
body in accordance with regulations of law on conformity assessment or
certificate of quality assessment issued by regulatory authority of Vietnam
(for an IVD medical device[193]):
original copy or certified true copy.
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1. Before placing Class-A or Class-B medical device[194] on the market,
the organization declaring applied standards (declarant) shall submit an
application for declaration to the Department of Health of province where it is
headquartered.
2. After receiving the application (including
application fee receipt as prescribed by the Ministry of Finance), the
Department of Health of province where the declarant of the medical device[195] is
headquartered shall publish the number of declaration of applied standards for
Class-A or Class-B medical device[196]
on the Portal on management of medical devices[197] and applications for declaration of
applied standards, except the documents specified in Clause 5 Article 26 of
this Decree.
3. In case of changes in the product owner[198], class of the
medical device[199],
category, intended purposes or indications for use of the medical device, or
provision of additional information about the manufacturer or product code, the
registration number holder shall reapply for declaration of applied standards
in accordance with regulations of this Decree.
4. During the placement of the medical device [200] on the market,
the product owner that has declared applied standards for the medical device
shall prepare written notice of changes, accompanied by supporting documents,
and update them to its application for declaration of applied standards
published on the Portal on management of medical devices[201] within 05 working days from the
occurrence of any of the following changes:
a) Change in address of the product owner[202] or registration
number holder of the medical device[203];
b) Change in name of the registration number holder
or product owner[204];
c) Change in the medical device[205] manufacturer’s name or address;
d) Change in packaging specifications;
dd) Change in the warranty center;
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g) Reduction of factories, category or product
code.
Section 3. REGISTRATION OF CLASS-C OR CLASS-D
MEDICAL DEVICES[207]
Article 29. Methods of registration
1. A new registration number shall be issued to a
medical device[208]
in the following cases:
a) The medical device[209] does not have any registration
number;
b) The medical device[210] has been granted registration number
but has any of the following changes:
- A change in the product owner[211]; class of the medical device[212]; category,
intended purposes or indications for use; quality standards; addition of
factory or product code; raw materials that affect the functions of IVD medical
device[213] or
disposable medical device[214];
concentration, content, composition of raw materials that are active
ingredients incorporated in the medical device[215] to support in medical treatment;
- A change other than those specified in Clause 7
Article 32 of this Decree.
2. Cases of quick issuance of new registration
number to a medical device[216]:
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b) The medical device has been granted the import
license or registration number or certificate of registration in the commercial
form in Vietnam, unless revoked before the effective date of this Decree;
3. Issuance of emergency use registration number
for medical devices[217]
to serve epidemic prevention and control, and disaster recovery purposes in
emergency cases included in the relevant List issued by the Minister of Health
and in one of the following cases:
a) The medical device has been placed on the market
or granted registration number for emergency use in one of the reference
countries;
b) The medical device is included in the list of
products for emergency use announced by the World Health Organization (WHO);
c) The medical device is included in the list of
common products announced by the EU Health Security Committee (EUHSC);
d) The medical device has been granted the
registration number or import license in the commercial form in Vietnam, unless
revoked before the effective date of this Decree;
dd) The medical device[218] is domestically manufactured in the
form of technology transfer in one of the cases specified in Points a, b, c or
d of this Clause;
e) The medical device[219] is domestically manufactured in the
form of processing in one of the cases specified in Points a, b, c or d of this
Clause.
Article 30. Application for issuance of a new
registration number
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a) The application form for issuance of a new
registration number.
b) An unexpired certificate of conformity with ISO
13845 quality control standards.
c) The unexpired letter of authorization given by
the product owner[221]
to the organization that applies for registration, except the case specified in
Point a Clause 1 Article 25 of this Decree.
The certificate of eligibility to provide warranty
services granted by the product owner[222], except disposable medical devices[223] defined by
product owners[224]
or cases where there are documents proving that the medical device is not under
warranty.
dd) The unexpired CFS (for imported medical devices[225]).
e) ASEAN Common Submission Dossier Template on the
medical device[226]
(hereinafter referred to as “CSDT”).
g) Certificate of conformity.
h)[227]
Certificate of results of clinical trial for medical device issued by a
competent authority, if the medical device is subject to a clinical trial as prescribed
in clause 2 Article 94 of the Law on Medical Examination and Treatment.
2. An application for issuance of a new
registration number for the medical device[228] that is a measuring device whose
sample requires approval as prescribed by the law on measurement consists
of:
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b) Decision on approval of the sample medical
device.
c) [229]
The documents specified in Points b, c, d, dd, e and h clause 1 of this
Article.
3. An application for quick issuance of a new
registration number for the medical device[230] as prescribed in Clause 2 Article 29
of this Decree consists of:
a) The application form for issuance of a new
registration number.
b) The documents specified in Points b, c, and d
Clause 1 of this Article.
c) The CFS issued by one of the reference countries
in the case prescribed in Point a Clause 2 Article 29 of this Decree.
d) The CFS of the imported medical device[231] and import
license or registration number or certificate of registration in the case
prescribed in Point b Clause 2 Article 29 of this Decree.
dd) Certificate of quality assessment issued by a competent
authority of Vietnam for IVD medical device[232], except the following cases:
- The medical device is included in List A or List
B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical
Devices[233] and
has been granted CFS by one of EU Member States, UK or Switzerland;
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- The medical device is not included in List A or
List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic
Medical Devices[235]
but has been granted the Marketing Authorization by one of the reference
countries;
- The medical device is included in the list of
medical devices announced by the Minister of Health.
e) The CSDT.
4. An application for issuance of a new
registration number for the medical device[236] in an emergency case prescribed in
Clause 3 Article 29 of this Decree consists of:
a) The application form for issuance of a new
registration number.
b) The documents specified in Points b, c, and d
Clause 1 of this Article.
c) The CFS or license for emergency use of the
imported medical device[237].
d) The contract for technology transfer in the case
prescribed in Point dd Clause 3 Article 29 of this Decree.
dd) The processing contract in the case prescribed
in Point e Clause 3 Article 29 of this Decree.
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- The medical device[238] is domestically manufactured;
- The medical device[239] has been granted permit for placement
on the market or emergency use by a competent authority of one of EU Member
States, UK or Switzerland but is not included in the EUHSC’s list of common
products.
g) The CSDT.
h) [240] Certificate of results of clinical
trial for medical device issued by a competent authority, if the medical device
is subject to a clinical trial as prescribed by law.
5. An application for issuance of a new
registration number for another medical device[241] consists of:
a) The application form for issuance of a new
registration number.
b) The documents specified in Points b, c, d and dd
Clause 1 of this Article.
c) The CSDT inspection record given by the
authority designated by the Minister of Health, accompanied by the CSDT.
d) With regard to IVD medical device[242] that is
reagent, calibrator or control material: certificate of quality issued by a
competent authority of Vietnam.
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e) [244]
Certificate of results of clinical trial for medical device issued by a
competent authority, if the medical device is subject to a clinical trial as
prescribed in clause 2 Article 94 of the Law on Medical Examination and
Treatment.
Article 31. Requirements for application for
issuance of a new registration number
1. Requirements for some documents included in the
application for registration:
a) Certificate of conformity with quality control
standards: original copy or certified true copy or copy bearing the applicant’s
certification.
If the Certificate of conformity with quality
control standards is not written in English or Vietnamese, it must be
translated into Vietnamese. The Vietnamese translation must be certified as
prescribed by law.
b) Product owner’s[245] letter of authorization and
certificate of eligibility to provide warranty:
- For a domestically manufactured medical device[246]: original copy
or certified true copy;
- For an imported medical device[247]: Either the document bearing consular
legalization or the certified true copy thereof is accepted.
c) CFS: Either the document bearing consular
legalization or the certified true copy thereof is accepted.
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d) Certificate of quality assessment, testing
report, trial report and CSDT inspection record: original copy or certified
true copy or copy bearing the applicant’s certification.
dd) CSDT: copy bearing the applicant’s
certification. If the CSDT is not written in English or Vietnamese, it must be
translated into Vietnamese. The Vietnamese translation must be certified as
prescribed by law.
2. Requirements for some documents included in an
application for registration of medical device for emergency use as prescribed
in Clause 3 Article 29 of this Decree:
Documents issued by foreign competent authorities
must bear consular legalization. Where a document does not bear consular
legalization:
a) With regard to the letter of authorization: its
original copy accompanied by certification shall be submitted.
b) With regard to the document specified in Point c
Clause 4 Article 30 of this Decree: it must indicate the link for searching
information on placement on the market or license for use of the medical device[248] on the
licensing authority’s website and be accompanied by a document providing the
link for searching information of the applicant. Information on placement of
the device on the market found on the website must include at least the
following information in English: name, category, manufacturer and
manufacturing country.
Article 32. Receipt and processing of
application for registration of medical devices[249]
1. The applicant shall submit an application for
registration number to the Ministry of Health through the Portal on management
of medical devices[250].
2. With regard to an application for registration
number for the medical device[251]
in the case prescribed in Clause 1 or Clause 2 Article 30 of this Decree:
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b) If the application is not satisfactory, the
Ministry of Health shall send a request for modification, in which such
documents and contents requiring modification must be specified, to the
applicant within 25 days from the receipt of the application.
c) The applicant shall comply with the request for
modification and send modified documents to the Ministry of Health as
requested.
If the modified application is still
unsatisfactory, the Ministry of Health shall continue sending a request for
modification to the applicant as prescribed in Point b Clause 2 of this
Article.
If the applicant fails to provide the modified
application within 90 days from the receipt of the Ministry of Health’s request
for modification or the application is still unsatisfactory after 05
modification times, the application shall be rejected.
3. With regard to an application for registration
number for the medical device[252]
in the case prescribed in Clause 3 Article 30 of this Decree:
a) If the application is satisfactory, the Minister
of Health shall process it within 15 days from the receipt of the adequate and
valid application (including the application fee receipt as prescribed by the
Ministry of Finance). If an application is refused, a written response
indicating reasons for such refusal shall be provided.
The Ministry of Health shall only appraise the
legal documents specified in Points b, c, d and dd Clause 1 Article 30 of this
Decree. The applicant shall assume responsibility for the accuracy and
legitimacy of other documents included in the application which may be
inspected by the Ministry of Health after issuing the registration number.
b) If the application for registration number is
not satisfactory, the Ministry of Health shall send a request for modification,
in which such documents and contents requiring modification must be specified,
to the applicant within 12 days from the receipt of the application.
c) [253]
The applicant shall comply with the request for modification and send modified
documents to the Ministry of Health as requested.
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If the applicant fails to provide the modified
application within 90 days from the receipt of the Ministry of Health’s request
for modification or the application is still unsatisfactory after 03
modification times, the application shall be rejected.
4. With regard to an application for registration
number for the medical device [254]
in the case prescribed in Clause 4 Article 30 of this Decree:
a) If the application is satisfactory, the Minister
of Health shall process it within 10 days from the receipt of the adequate and
valid application (including the application fee receipt as prescribed by the
Ministry of Finance). If an application is refused, a written response
indicating reasons for such refusal shall be provided.
The Ministry of Health shall only appraise the
legal documents specified in Points b, c, d, dd and e Clause 4 Article 30 of
this Decree. The applicant shall assume responsibility for the accuracy and
legitimacy of other documents included in the application which may be
inspected by the Ministry of Health after issuing the registration number.
b) If the application for registration number is
not satisfactory, the Ministry of Health shall send a request for modification,
in which such documents and contents requiring modification must be specified,
to the applicant within 08 days from the receipt of the application.
c) The applicant shall comply with the request for
modification and send modified documents to the Ministry of Health as
requested.
If the modified application is still
unsatisfactory, the Ministry of Health shall continue sending another request
for modification to the applicant as prescribed in Point b Clause 4 of this
Article.
If the applicant fails to provide the modified
application within 90 days from the receipt of the Ministry of Health’s request
for modification, the application shall be rejected.
5. With regard to an application for registration
number for the medical device[255]
in the case prescribed in Clause 5 Article 30 of this Decree:
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b) If the application for registration number is
not satisfactory, the Ministry of Health shall send a request for modification,
in which such documents and contents requiring modification must be specified,
to the applicant within 40 days from the receipt of the application.
c) The applicant shall comply with the request for
modification and send modified documents to the Ministry of Health as
requested.
If the modified application is still
unsatisfactory, the Ministry of Health shall continue sending another request
for modification to the applicant as prescribed in Point b Clause 5 of this
Article.
If the applicant fails to provide the modified
application within 90 days from the receipt of the Ministry of Health’s request
for modification or the application is still unsatisfactory after 05
modification times, the application shall be rejected.
6. Within 01 working day from the issuance of the
registration number, the Ministry of Health shall publish the following
information on the Portal on management of medical devices[256], including:
a) Name, category, manufacturer and manufacturing
country of the medical device[257];
b) Registration number of the medical device [258];
c) Name and address of the product owner[259];
d) Name and address of the registration number
holder;
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e) The documents included in the application for
registration of the medical device[261],
except the documents specified in Point e Clause 1 and Point c Clause 5 of
Article 30;
g) Intended purposes of the medical device[262].
7. During the placement of the medical device[263] on the market,
the registration number holder shall prepare written notice of changes,
accompanied by supporting documents, and update them to its application for registration
number published on the Portal on management of medical devices[264] within 10
working days from the occurrence of any of the following changes:
a) Change in address of the product owner[265] or registration
number holder of the medical device[266];
b) Change in name of the registration number holder
or product owner[267];
c) Change in the medical device[268] manufacturer’s name or address;
d) Change in packaging specifications;
dd) Change in the warranty center;
e) Change in the label or user manual without
changing intended purposes, indications for use, functions or performance of
the medical device[269].
Where the medical device[270]
has been manufactured before the registration number holder makes a notice of
change in the label, the device may be placed on the market with information
registered and updated at the date of manufacture.
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1. Processing of applications for registration
number for medical devices shall be prioritized in the following cases:
a) Domestically manufactured medical devices;
b) Imported medical devices for which applications
for import license have been submitted to the Ministry of Health of Vietnam
before January 01, 2022 but not yet been processed, and for which applications
for registration number have also been submitted;
c) Chemicals and preparations which are only used
for decontamination of medical devices;
d) Medical devices which are employed for
performing new techniques or methods in medical examination and treatment under
official approvals given by the Ministry of Health of Vietnam but for which
registration numbers have not yet been granted in Vietnam;
dd) Medical devices for which there is no change in
information on type and HS code on the unexpired import license or decision to
grant registration number or certificate of registration but which is subject
to one of the following cases:
- Changes in the importer or the applicant for
registration number;
- Changes in name of the manufacturer but its
address remains unchanged;
- Changes in name of the medical device’s owner but
its address remains unchanged;
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g) The Ministry of Health of Vietnam has given a
document rejecting, or requesting modification of, the submitted application
for registration number due to validity of one of the following documents:
letter of authorization of the registration number holder, certificate of
conformity with ISO 13485 quality standards, or certificate of registration for
the medical device;
h) The Ministry of Health of Vietnam has given a
document rejecting, or requesting modification of, the submitted application
for registration number due to the name of the medical device.
2. Procedures for priority processing of an
application for registration number:
a) The applicant shall submit the following
documents to the Ministry of Health of Vietnam:
- An application form for priority processing of
the application which must indicate adequate information on the code of the
submitted application for registration number on the website of the Ministry of
Health of Vietnam;
- Corresponding support documents for the cases
specified in clause 1 of this Article;
b) The Ministry of Health of Vietnam shall consider
permitting the priority processing of application for registration number for
medical device within 10 working days from its receipt of the application form
for priority processing and accompanied documents. If an application is refused,
a written response indicating reasons for such refusal shall be provided.
3. Applications for license to import medical
devices prescribed in point b clause 1 of this Article for which certificate of
registration has been issued shall not be rejected.
Section 4. POST-MARKET MANAGEMENT OF MEDICAL
DEVICES[272] AND
HANDLING OF MEDICAL DEVICES[273]
IN SOME SPECIFIC CASES
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The registration number holder shall organize and
manage the tracing of origin of medical devices[275] placed on the market and fully retain
at least the following documents to serve its management of medical devices:
1. The application for issuance of registration
number for medical device[276]
of which the following documents shall be retained in physical form:
a) The letter of authorization given by the product
owner[277] to the
organization that applies for registration, except the case specified in Point
a Clause 1 Article 25 of this Decree;
b) The certificate of eligibility to provide
warranty granted by the product owner[278], except disposable medical devices[279] defined by
product owners[280]
or cases where there are documents proving that the medical device is not under
warranty;
c) The CFS or marketing authorization.
2. Distribution records (if the registration number
holder is a representative office, it shall not be required to retain these
records but must request the entity that it authorizes to import the medical
device to perform this responsibility).
3. Records of adverse events, complaints and
corrective actions that indicate name, category, quantity and batch number of
the medical device[281],
especially those[282]
that are defective or unsafe for users.
4. Medical device[283] quality management documents,
including:
a) The Certificate of Origin made in accordance
with regulations of law on origin of goods;
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c) Record of inspection of medical device[286] in respect of
the medical devices[287]
specified in Clause 1 Article 55 of this Decree;
d) Technical documents serving the repair and
maintenance of the medical device[288],
except disposable medical devices[289]
defined by product owners[290]
or cases where there are documents proving that the medical device is not under
warranty;
dd) Instructions for use of the medical device[291] are given in
Vietnamese;
e) Information about warranty center, conditions
and time for warranty, except disposable medical devices[292] defined by the product owner[293] or cases where
there are documents proving that the medical device is not under warranty.
Article 34. Handling of medical devices[294] that pose a
serious threat to public health or may cause death of users
1. In case where a Vietnamese or international
competent authority issues a warning against a medical device[295] that poses a serious threat to public
health or may cause death of users, the registration number holder shall inform
health facilities using such medical device[296] of the warning and carry out
investigations within 30 days from the receipt of such warning. If the investigation
cannot be finished within 30 days, a report specifying reasons and solutions
for ensuring safety of users shall be submitted to the Ministry of Health.
2. In case the medical device[297] specified in Clause 1 of this Article
is certified a defective medical device[298] which may affect the health of users,
the registration number holder shall:
a) Suspend the placement of the batch of medical
devices[299] on
the market.
b) Send a written notice to the Ministry of Health,
distributors and users of such medical device[300]. The notice shall specify the batch
number and the defect, and whether or not such defect can be repaired.
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d) Send a report to the Ministry of Health after
the repair or recall of defective medical devices[302] is completed.
3. If the defect in the medical device[303] can be
repaired:
a) Within 03 working days from the receipt of the
notice from the registration number holder of the medical device[304], the Ministry
of Health shall issue a decision to suspend the placement of the batch of
defective medical devices[305]
on the market.
A suspension decision shall contain the following
information:
- Name of the medical device[306] suspended from placement on the
market;
- Batch number of the medical device[307];
- Registration number of the medical device[308].
b) After a decision to suspend the placement of the
batch of medical devices[309]
on the market is issued, the registration number holder shall repair the
defect, which causes adverse effects to the health of users.
c) After completing the repair of the defect, the
registration number holder shall send a report accompanied by the inspection
record (for the medical device310] specified in Clause 1 Article 55 of this
Decree) or commitment to maintain quality of the medical device[311] after the
defect has been repaired (for other medical device[312]) to the Ministry of Health.
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4. If the defect in the medical device[315] cannot be
repaired:
a) The Ministry of Health shall issue a decision to
recall the entire batch of defective medical devices[316].
A recall decision shall contain the following
information:
- Name of the medical device[317] to be recalled;
- Batch number of the medical device[318] to be recalled;
- Registration number of the medical device[319].
b) The registration number holder shall recall the
entire batch of defective medical devices[320] by the deadline imposed by a competent
authority and pay the cost of recall of the entire batch of defective medical
devices[321].
c) If the registration number holder fails to
complete the recall of the batch of defective medical devices[322] by the deadline imposed by the
competent authority, the recall will be enforced in accordance with regulations
of law on handling of administrative violations.
Article 35. Actions against adverse events (AE)
associated with medical devices[323]
that have caused harm to health of users
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a) Post a notice of the AE on the registration
number holder’s website (if any) and send written notices of the AE to the
Ministry of Health, traders and users of that batch of medical devices[325];
b) Suspend the placement on the market of the batch
of medical devices[326]
involving the AE;
c) Initiate an investigation into the causes of the
AE;
d) Send a report to the Ministry of Health after
the investigation result is available. If the AE is caused by a defect in the
medical device[327],
the report shall describe the defect and whether it can be repaired. Carry out
repair of the defect or recall of the batch of defective medical devices[328], submit a
report to the Ministry of Health after completing the repair or recall of the
batch of defective medical devices[329].
2. In case the AE associated with the use of a
medical device[330]
does not cause death but has caused serious harm to the health of users, the
registration number holder shall:
a) Send a notice of the AE to the Ministry of
Health;
b) Initiate an investigation into the causes of the
AE;
c) Send a report to the Ministry of Health after
the investigation result is available. If the AE is caused by a defect in the
medical device[331],
the report shall describe the defect and whether it can be repaired. Carry out
repair of the defect or recall of the batch of defective medical devices[332], submit a
report to the Ministry of Health after completing the repair or recall of the
batch of defective medical devices[333].
3. The medical device[334] that has a defect that causes harm to
health of users shall be handled in accordance with Clause 3 and Clause 4
Article 34 of this Decree.
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1. Methods for handling defective medical devices[336]:
a) Providing instructions on how to fix the defect;
b) Fixing the defect in medical devices [337];
c) Replace the defective medical device[338] with an
equivalent medical device[339];
d) Recall the defective medical device for
re-export or destruction;
2. Methods for recall of the defective medical
devices[340]:
a) Voluntary recall by the registration number
holder;
b) Mandatory recall in the cases specified in
Article 39 of this Decree.
Article 37. Handling of medical devices[341] in case product
owner[342]
or registration number holder of medical device[343] no longer carries out manufacturing
or goes bankrupt or is dissolved
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2. If the registration number holder[350] of a medical
device[349] goes
bankrupt or is dissolved, the medical device may be placed on the market for a
maximum period of 24 months from the date of the registration number holder’s[351] declaration of
bankruptcy or dissolution provided that the distributor provides a commitment
to provide warranty or materials for replacing or serving the use of the
medical device[352]
for 08 years.
3. The registration number holder or distributor
shall send their commitments to the Ministry of Health through the Portal on
management of medical devices[353]
within 60 days from the day on which the product owner[354] or registration number holder of the
medical device[355]
declares termination of manufacturing or goes bankrupt or is dissolved.
4. The commitment shall include the following
documents:
a) The written commitment to provide warranty and
materials serving the use of the medical devices[356];
b) The list of medical devices[357] of which it is the registration
number holder but the product owner[358]
or registration number holder of the medical device [359] declares termination of manufacturing
or goes bankrupt or is dissolved.
5. Within 15 working days from the receipt of the
commitment as prescribed in Clause 4 of this Article, the Ministry of Health
shall give a written response indicating whether or not the medical device[360] may be placed
on the market. If the placement of the medical device on the market is not
approved, reasons for such refusal shall be given.
6. [361] If the Ministry of Health of Vietnam
has given a written response indicating its refusal to permit the placement of
the medical device[362]
on the market as prescribed in Clause 5 of this Article, the registration number
holder or distributor shall conduct the recall of medical devices[363] placed on the
market, except medical devices[364]
sold to health facilities or users.
Section 5 [365]. REVOCATION OF REGISTRATION NUMBER OF
MEDICAL DEVICES[366]
AND DISPOSAL OF MEDICAL DEVICES[367]
WHOSE REGISTRATION NUMBER IS REVOKED
Article 38. Cases where registration number is
revoked
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2. In case where 03 batches of the medical device[368] are recalled
during the validity of the registration number, except registration number
holder’s voluntary recall of the medical device.
3. The applicant deliberately alters or erasures
the contents of the registration number.
4. The registration number holder shuts down or is
no longer authorized by the product owner[369] and no substitute is appointed,
except the case specified in Article 37 of this Decree.
5. Quality of the medical device[370] placed on the market is not
consistent with the registered quality.
6. The registration number has been issued against
regulations of this Decree.
7. The registration number holder or distributor
has not provided commitment for the medical device[371] as prescribed in Clause 1 and Clause
2 Article 37 of this Decree.
8. The period for placing the medical device[372] on the market
expires as prescribed in Clause 1 or Clause 2 Article 37 of this Decree.
9. The medical device[373] has been manufactured at a factory
that fails to satisfy eligibility requirements laid down in this Decree.
10. The registration number holder fails to comply
with the provision of Point k Clause 3 Article 74 of this Decree, except the
case specified in Article 37 of this Decree.
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12. The medical device[374] has been classified against
regulations on classification of medical devices[375].
13. The registration number holder applies for
voluntary revocation of the registration number.
14. [376] A document included in the
application for registration of medical device[377] is found by a competent authority to
be unconformable with regulations of law.
Article 39. Procedures for revocation of
registration number
1. If any of the cases specified in Clauses 1
through 12 Article 38 of this Decree is discovered during the inspection, the
inspecting agency shall prepare and send an inspection record to the Ministry
of Health or Provincial Department of Health that has issued the registration
number (hereinafter referred to as “registration number issuer”).
2. Within 05 working days from the receipt of the
inspection record specified in Clause 1 of this Article, the registration
number issuer shall consider issuing a decision to revoke registration number
under their management.
3. After issuing the decision to revoke
registration number, the registration number issuer shall:
a) Publish the decision to revoke registration
number on its website and send it to the registration number holder, Ministry
of Health, Provincial Departments of Health and customs authorities.
b) Remove all information related to the medical
device[378]
published on its website.
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5. Where the registration number holder applies for
revocation of registration number, an application indicating reasons for such
revocation shall be submitted to the registration number issuer. After
receiving the application, the registration number issuer shall carry out
procedures for revocation of registration number as prescribed in Clause 2 and
Clause 3 of this Article.
6. [380] Within 05 working days from the
receipt of the written conclusion from a competent authority as prescribed in
Clause 14 Article 38 of this Decree, the registration number issuer shall
consider issuing a document on revocation of registration number under its
jurisdiction.
Upon receipt of the document on revocation of
registration number, relevant competent authorities shall follow the procedures
in Clauses 3 and 4 of this Article.
Article 39a. Disposal
of medical devices[381]
whose registration is revoked[382]
1. Medical devices[383] which have been sold to health
facilities or users shall still be used until they are liquidated as prescribed
by law or they reach their expiry date, except medical devices[384] containing defects which are harmful to
user’s health but cannot be repaired as prescribed in Clause 4 Article 34 of
this Decree.
2. Where a medical device[385] whose registration number is revoked
is not yet sold to users or health facilities, the registration number holder
shall suspend the placement of that medical device[386] on the market and implement measures
for recalling it[387].
Chapter VI
MANAGEMENT OF TRADING OF MEDICAL DEVICES [388]
Section 1. ELIGIBILITY REQUIREMENTS TO BE
SATISFIED BY TRADING ESTABLISHMENTS[389]
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To be permitted to trade in Class-B, C, D medical
devices, an establishment must:
1. Have at least 01 employee who has an associate degree, or higher, in
technology, medicine, pharmacy, chemistry, biology or medical devices, or an
associate degree, or higher, suitable for the medical devices[391] sold by the establishment.
2. Have warehouse and vehicles that satisfy the
following requirements:
a) The warehouse must:
- have an area suitable for the categories and
quantities of medical devices[392]
stored therein;
- be well ventilated, dry and clean, and separated
from sources of pollution;
- satisfy storage requirements for the medical
devices[393] laid
down in their user manuals.
b) The vehicle for delivery of medical devices[394] are suitable
for the medical devices[395]
delivered;
A trading establishment that does not have a
warehouse or vehicle for storing or transporting medical devices[396] may sign a
contract with a qualified medical device[397] storage or transport service
provider.
3. Requirements for trading in medical devices[398] that contain
narcotic substances or precursors:
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b) The trading establishment must have a warehouse
that satisfies the requirements laid down in Article 7 of the Government’s
Decree No. 80/2001/ND-CP dated November 05, 2001.
c) There is an inventory monitoring system for
medical devices[400]
containing narcotic substances and precursors.
Article 41. Application and procedures for
declaration of eligibility for medical device[401] trading
1. An application for declaration of eligibility
for medical device[402]
trading consists of:
a) The declaration of eligibility for medical
device[403]
trading;
b) A personnel list;
c) Documents proving that the warehouse and vehicle
for storing and transporting medical devices[404] satisfy the requirements specified in
Clause 2 Article 40 of this Decree. These documents must be certified by the
applicant;
d) Documents proving that the warehouse and
inventory monitoring system for medical devices[405] containing narcotic substances and
precursors comply with the requirements laid down in Clause 3 Article 40 of
this Decree. Such documents shall be certified by the establishment making
declaration of eligibility for trading in medical devices[406] that contain narcotic substances and
precursors.
2. Procedures for declaration of eligibility for
medical device trading:
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b) After receiving the application (including the
application fee payment as prescribed by the Ministry of Finance), the
Department of Health of province where the medical device[409] trading establishment is
headquartered shall publish on the Portal on management of medical devices[410] all information
about and application for declaration of eligibility for medical device[411] trading.
c) During its operation, the trading establishment
shall prepare a notice of changes which is accompanied by supporting documents
for such changes, and update such documents to its application for declaration
of eligibility for medical device trading published on the Portal on management
of medical devices[412]
within 03 working days from the occurrence of such changes.
Article 42. Trading in medical devices[413] without
satisfying eligibility requirements and following procedures for declaration of
eligibility for medical device trading
1. Class-B, C, D medical devices[414] included in the list of medical
devices[415]
promulgated by the Minister of Health shall be traded as normal goods.
2. Establishments trading in the medical devices[416] prescribed in
Clause 1 of this Article shall not be required to satisfy eligibility
requirements laid down in Article 40 of this Decree and follow procedures for
declaration of eligibility for medical device trading as prescribed in Article
41 of this Article but must still meet the storage and transport requirements
as prescribed by product owners[417].
Section 2. MANAGEMENT OF PRICES OF MEDICAL
DEVICES[418]
Article 43. Rules for state management of
medical device[419]
prices
1. Manage prices of medical devices[420] according to
the market mechanism; respect the right to pricing and price competition of
entities trading in medical devices[421]
in accordance with regulations of law.
2. Ensure transparency of prices of medical devices[422] placed on the
market.
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4. Take measures for ensuring management of medical
device[423] prices
appropriate for socio-economic development in each period.
Article 44. Posting prices of medical devices [424] [425]
1. Manufacturers and traders of medical devices[426] shall post
prices of medical devices[427]
at the locations prescribed in Article 17 of the Government’s Decree No.
177/2013/ND-CP dated November 14, 2013 or on the web portal of the Ministry of
Health of Vietnam.
2. The following information must be provided when
posting prices of medical devices[428]
on the web portal of the Ministry of Health of Vietnam:
a) Name and category of the medical device[429];
b) Manufacturer and manufacturing country; product
owner and country of product owner;
c) Unit;
d) Configurations, technical functions of the
medical device[430];
dd) Price of medical device[431].
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1. Manufacturers and traders of medical devices
shall declare prices of their medical devices; contents and procedures for
declaring prices of medical devices[434]
shall comply with regulations of law on pricing.
2. Based on actual situations and upon the
occurrence of considerable changes in prices which affect the supply of medical
devices[435],
payment capacity of buyers and the health insurance fund, the Minister of
Health of Vietnam shall promulgate, update and revise the list of medical
devices[436]
subject to compulsory price declaration and guidelines thereon.
3. Manufacturers and traders of medical devices[437] shall declare
prices of their medical devices[438]
in the forms specified in the law on pricing or on the web portal of the
Ministry of Health of Vietnam.
Section 3. EXPORT AND IMPORT OF MEDICAL DEVICES[439]
Article 46. Rules for management of import and
export of medical devices[440]
[441]
1. Importers and exporters of medical devices[442] must satisfy
eligibility requirements laid down in the law on import and export and assume
responsibility to ensure quality, quantities, categories and intended purposes
of their imported/exported medical devices[443].
2. Medical devices[444] that have been granted registration
numbers in Vietnam may be exported and imported without limits on quantities
and are exempt from approval of the Ministry of Health of Vietnam.
3. The import license is required for the medical
devices[445]
specified in Clause 1 Article 48 of this Decree which are imported for use in
Vietnam.
4. The transport of medical devices[446] other than
those specified in Clause 2 and Clause 3 of this Article into Vietnam in other
forms shall comply with regulations of the law on foreign trade management.
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6. Import of used medical devices[448] shall comply with regulations of the
law on foreign trade management.
Article 47. Export and import of medical devices[449]
1. Domestic enterprises are encouraged to
manufacture medical devices for export.
2. An organization or individual that wishes to
import the medical device[450]
that has been granted registration number shall:
a) be the registration number holder or be
authorized in writing by the registration number holder. When authorizing
import of medical devices[451],
the registration number holder shall send a copy of the authorization letter to
the registration number issuer and the customs authority;
b) have a warehouse and vehicles satisfying the
requirements laid down in Clause 2 Article 40 of this Decree or have entered
into a contract with a qualified medical device[452] storage and transport service
provider;
c) have a warehouse and an inventory monitoring
system for medical devices[453]
containing narcotic substances and precursors that meet the requirements laid
down in Clause 3 Article 40 of this Decree.
3. Procedures for import and export of medical
devices[454] shall
comply with regulations of the law on customs. Importers of medical devices[455] shall not be
required to prove their satisfaction of the requirements laid down in Clause 2
of this Article when following customs procedures.
Article 48. Import license
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a) Unregistered medical devices[456] are imported to serve scientific
research, testing, inspection, experiment, performance evaluation, or
instruction for use or modification of medical devices[457] only;
b) Unregistered medical devices[458] are imported to serve epidemic
prevention and control, or disaster recovery;
c) Unregistered medical devices[459] are imported as assistance or
humanitarian aid; gifts or presents given to health facilities; or to serve
display at trade fair, exhibition or product launch event;
d) Unregistered medical devices[460] are imported to serve charitable
medical examination and treatment;
dd) Unregistered medical devices[461] are imported for personal treatment
of illness, including personalized medical devices[462], or to serve a health facility’s
special diagnosis demand;
e) [463]
Unregistered medical devices[464]
are imported for use in health facilities with ODA funding and concessional
loans or grants other than ODA grants.
2. An application for the import license consists
of:
a) The application form for import license;
b) A synopsis of the technical description of the
medical device[465]
in Vietnamese;
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d) If the medical device is imported to serve
research: a certified true copy of the decision to approve the research and documents
bearing the applicant’s certification proving that the medical device[467] has been
granted marketing authorization by a competent authority;
dd) If the medical device is imported to serve
training purposes: the original copy of the training program and
documents bearing the applicant’s certification proving that the medical device[468] has been
granted marketing authorization by a competent authority;
e) If the medical device is imported to serve
testing, inspection, experiment, or performance evaluation: the certification
indicating the quantity of the imported device given by the agency competent to
carry out such testing, inspection, experiment, or performance evaluation;
g) If the medical device is imported as aid: a copy
of the decision to approve the aid and documents bearing the applicant’s
certification proving that the medical device[469] has been granted marketing
authorization by a competent authority;
h) If the medical device is imported as gift or
present given to a health facility: the original copy of the training
program and documents bearing the applicant’s certification proving that the
medical device[470]
has been granted marketing authorization by a competent authority;
i) If the medical device is imported to serve
charitable medical examination and treatment: documents bearing the applicant’s
certification proving that the medical device[471] has been granted marketing
authorization by a competent authority;
k) If the medical device is imported to serve a
health facility’s special diagnosis demand: documents bearing the applicant’s
certification proving that the medical device[472] has been granted marketing
authorization by a competent authority;
l) If the medical device is imported to serve
personal treatment of illness, including personalized medical devices[473]: a copy of the
physician’s prescription which is consistent with the applicant’s illness;
m) If the medical device is imported to serve a
trade fair, exhibition, display or product launch event: copies of documents on
the program, invitation letter and service contract;
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- A competent authority’s approval for import of
the medical device to serve epidemic prevention and control or disaster
recovery;
- Documents bearing the applicant’s certification
proving that the medical device[474]
has been granted marketing authorization or license for emergency use by a
competent authority.
o) [475]
In the case specified in Point e Clause 1 of this Article, the application for
import license shall include:
- The original copies or certified true copies of
the decision to approve the investment guidelines and the investment decision
for an investment project or the decision to approve project documents for a
project on technical assistance, project costs or grants other than ODA grants,
in which the import of medical devices[476] must be indicated;
- The original copy of certified true copy of the
contract for supply of medical devices[477] for the project;
- The power of attorney granted by the product
owner[478] to the
applicant which must be still valid at the date of application submission.
Either the document bearing consular legalization or the certified true copy
thereof is accepted;
- The certificate of eligibility to provide
warranty services granted by the product owner[479], except disposable medical devices[480] defined by
product owners[481]
or cases where there are documents proving that the medical device is not under
warranty. Either the document bearing consular legalization or the certified
true copy thereof is accepted;
- dd) The unexpired CFS (for imported medical
devices[482]).
Either the document bearing consular legalization or the certified true copy
thereof is accepted. If the CFS is made neither in English nor in Vietnamese,
it shall be translated into Vietnamese. The Vietnamese translation must be
certified as prescribed by law.
3. Procedures for processing an application for
license to import medical devices[483]:
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The import license shall be sent to the applicant
and customs authorities.
b) If the application for license to import medical
devices[486] is
not satisfactory, the Ministry of Health shall send a request for modification,
in which such documents and contents requiring modification must be specified,
to the applicant for license to import medical devices[487] within 10 days, or 02 working days
with respect to an unregistered medical device [488] that is imported to serve epidemic prevention
and control or disaster recovery, from the receipt of the application.
c) The applicant shall comply with the request for
modification and send modified documents to the Ministry of Health as
requested.
If the modified application is still unsatisfactory,
the Ministry of Health shall continue sending another request for modification
of the application to the applicant.
d) If the applicant fails to provide the modified
application within 30 days from the receipt of the Ministry of Health’s request
for modification, the application shall be rejected.
dd) If the modified application is satisfactory,
the Ministry of Health shall issue an import license in accordance with Point a
of this Clause. The import license shall be sent to the applicant and customs
authorities.
Article 49. Application for Certificate of Free
Sale (CFS) for medical devices[489]
1. An application for CFS for a medical device[490] consists of:
a) The application form for CFS.
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2. Procedures for the CFS shall comply with the
Government’s Decree No. 69/2018/ND-CP dated May 15, 2018.
Article 50. Authority and procedures for
issuance, re-issuance and revocation of CFS
1. The Minister of Health shall consider issuing,
re-issuing and revoking CFS for medical devices[491].
2. Procedures for issuance, re-issuance and
revocation of CFS shall comply with the Prime Minister’s regulations on
issuance of CFS.
Section 4. RIGHTS AND OBLIGATIONS OF
ORGANIZATIONS AND INDIVIDUALS ENGAGED IN TRADING OF MEDICAL DEVICES[492]
Article 51. Rights of medical device[493] trading
establishments
1. Request the medical device[494] seller to provide adequate
information and documents serving the tracing of origin and warranty on the
medical device[495].
2. Request importers, distributors and users to
cooperate in recalling and handling defective medical devices[496].
3. Request the registration number holder[497] or warranty
center that is recognized by the product owner[498] to provide warranty on the medical
device[499].
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5. Exercise other rights as prescribed by laws.
Article 52. Obligations of medical device[501] trading
establishments
1. Implement internal control measures to maintain
the quality of medical devices[502]
as prescribed by the registration number holder.
2. Provide users with adequate and timely
information about:
a) Instructions for use of medical devices[503]; conditions for
ensuring safety, storage, calibration, inspection and maintenance of medical
devices[504];
b) Notices of defective medical devices[505].
3. [506] Post and declare prices of medical
devices[507] in
accordance with the provisions of this Decree and the law on pricing.
4. Keep documents on management of medical devices[508] and carry out
tracing of origin and recall of medical devices[509] in accordance with regulations of
this Decree.
5. Promptly notify registration number holders and
state regulatory authorities of defective medical devices[510].
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7. Perform other obligations as prescribed by law.
Chapter VII
MEDICAL DEVICE-RELATED SERVICES [511]
Section 1. MEDICAL DEVICE[512] TECHNICAL CONSULTING
Article 53. Eligibility requirements to provide
medical device[513]
technical consulting
1. Consulting on listing and formulation of
technical configuration and functions of medical devices[514] must be provided by individuals who
have certificates of completion of training course in technical consulting on
medical devices.
2. An individual who provides medical device
technical consulting is required to:
a) have a bachelor’s degree, or higher, in
technology, medicine or pharmacy;
b) have at least 05 years’ experience of working in
medical device [515]
technology in health facilities;
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3. A consultant shall only provide medical device
technical consulting after the Ministry of Health publishes his/her information
and application for declaration of eligibility to provide medical device
technical consulting as prescribed in Point b Clause 2 Article 54 of this Decree.
Article 54. Application and procedures for
declaration of eligibility to provide medical device technical consulting
1. An application for declaration of eligibility to
provide medical device technical consulting consists of:
a) The application form for declaration of
eligibility to provide medical device technical consulting;
b) Certified true copies of
qualifications/certificates as prescribed in Point a and Point c Clause 2
Article 53 of this Decree;
c) Certificate of working period.
2. Procedures for declaration of eligibility to
provide medical device technical consulting:
a) Before providing medical device technical
consulting, the applicant shall send an application for declaration of
eligibility to provide medical device technical consulting to the Ministry of
Health.
b) After receiving the application (including
application fee receipt as prescribed by the Ministry of Finance), the Ministry
of Health shall publish on the Portal on management of medical devices[517] all information
about and application for declaration of eligibility to provide medical device[518] technical
consulting.
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Section 2. INSPECTION AND CALIBRATION OF MEDICAL
DEVICES[520]
Article 55. Rules for inspection and calibration
of medical devices[521]
1. Medical devices[522] included in the Minister of Health’s
list shall undergo safety and function inspection before use (except for the
cases in Article 57 of this Decree), periodically and after overhaul.
Inspection of medical devices[523]
that are measuring devices or radiation equipment shall be carried out in
accordance with Clause 2 of this Article.
2. Medical devices[524] that are measuring devices or
radiation equipment shall undergo inspection and calibration in accordance with
regulations of laws on measurement and atomic energy.
Article 56. Requirements for provision of
medical device[525]
inspection services
Facilities and personnel requirements, preparation
and submission of application for certificate of registration of medical device
inspection services, issuance, revision, re-issuance and revocation of
certificate of registration of medical device[526] inspection services are the same as
those for provision of conformity assessment services.
Regarding the satisfaction of professional
requirements for each medical device[527]
inspection field: each inspection process registered must be handled by at
least 02 inspectors who have certificates of completion of training program in
such process.
Article 57. Exemption from first inspection
before putting medical devices[528]
into service
A medical device[529] shall be exempted from the first
inspection before it is put into service in one of the following cases:
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2. The unregistered medical device[531] is imported to serve scientific
research or training in use, maintenance or repair of such medical device[532].
3. The unregistered medical device[533] is imported to serve the importer’s
personal treatment of illness or charitable medical examination and treatment
or special diagnostic purposes.
4. The unregistered medical device[534] is imported for display at a trade
fair, exhibition or product launch event.
Article 58. Handling of unqualified medical
devices[535]
1. In case the result of the inspection conducted
before putting the medical device[536]
into service is not satisfactory:
a) Health facilities shall not receive and use that
medical device[537];
b) The inspecting organization shall send a written
notice of unsatisfactory inspection result to the Ministry of Health;
c) If 03 medical devices[538] of the same batch fail to meet the
safety and function inspection requirements, the Ministry of Health shall
request the registration number holders in writing to send reports on the
quantity of medical devices being placed on the market and those being used in
health facilities.
Registration number holders’ reports and the
unsatisfactory inspection result are the basis for the Ministry of Health to
decide whether to carry out a re-inspection, the quantity of medical devices
that have to undergo re-inspection, or suspend the use of such medical devices[539].
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In case 03 batches of medical devices[541] are recalled
during the validity of the registration number, the registration number of the
medical device[542]
shall be revoked. Medical devices[543]
that have been used by health facilities before the issuance of the decision to
revoke the registration number may be used if they pass the inspection.
2. In case the result of a periodic inspection or
post-overhaul inspection of a medical device[544] is not satisfactory:
a) Health facilities shall not receive and use that
medical device[545];
b) The marking of the previous inspection result
shall be removed;
c) Health facilities shall cooperate with the
registration number holder in implementing corrective measures and carrying out
a re-inspection;
d) Only the medical device that passes the
re-inspection may be used.
Chapter VIII
MANAGEMENT OF RAW MATERIALS FOR MANUFACTURE OF MEDICAL
DEVICES[546],
SUBSTANCES FOR EXTERNAL QUALITY
ASSESSMENT THAT CONTAIN NARCOTIC SUBSTANCES AND PRECURSORS
Article 59. Rules for management of raw
materials for manufacture of medical devices[547], substances for external quality
assessment that contain narcotic substances and precursors
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2. Customs clearance shall be granted according to
declaration number and does not require the import license issued by the
Ministry of Health.
Article 60. Application and procedures for
declaration of raw materials for manufacture of medical devices[549], substances for
external quality assessment that contain narcotic substances and precursors
1. An application for declaration consists of:
a) Declaration form of raw materials for
manufacture of medical devices[550],
substances for external quality assessment that contain narcotic substances and
precursors;
b) Certificate of conformity with quality control
standards;
c) Technical documents.
2. Procedures for declaration of
concentration/content of narcotic substances and precursors:
a) Before importing raw materials for manufacture
of medical devices[551]
and substances for external quality assessment that contain narcotic substances
and precursors, the importer is required to publish an adequate and valid
application for declaration as prescribed in Clause 1 of this Article on the
Portal on management of medical devices[552];
b) After receiving an adequate and valid
application, the Ministry of Health shall publish on the Portal on management
of medical devices[553]
all information and the application for declaration of raw materials for
manufacture of medical devices[554]
and substances for external quality assessment that contain narcotic substances
and precursors.
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Chapter IX
INFORMATION ON MEDICAL DEVICES [555]
Article 61. Information on medical devices [556]
1. Information on a medical device[557] is meant to provide medical
practitioners and medical device[558]
users with instructions on how to use the medical device[559] reasonably and safely.
2. Information on a medical device[560] must be adequate, objective,
accurate, truthful and easily understandable and must not cause
misunderstanding.
3. Responsibility to provide information on medical
devices[561]:
a) Registration number holders and trading
establishments of medical devices[562]
shall publish information on levels of risks and other information related to
the use of medical devices[563];
b) Health facilities shall internally disseminate
information on medical devices[564];
c) Healthcare workers shall disseminate information
on levels of risks of Class-C, D medical devices[565] to patients;
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4. Providers of information on medical devices[568] shall assume
responsibility for their provided information.
5. The Minister of Health shall organize a medical
device[569]
information system.
Article 62. Advertising of medical devices[570]
1. Contents of an advertisement for a medical
device[571] must
be consistent with one of the following documents:
a) The application for declaration of applied
standards of Class-A or Class-B medical device[572];
b) The application for registration of Class-C or
Class-D medical device[573].
2. An advertisement for a medical device[574] shall, inter
alia, have the following information:
a) Name, category, product code, manufacturer and
manufacturing country of the medical device[575];
b) Registration number;
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d) Name and address of the registration number
holder[576] or the
entity authorized by the registration number holder[577];
dd) Warnings for medical device users and storage
conditions (if any).
3. Audio or video advertisement of medical devices[578] must contain
sufficient information specified in Clause 2 of this Article which must be read
or displayed clearly.
4. Before carrying out the advertising of a medical
device, the registration number holder[579] or the entity authorized in writing
by the registration number holder[580]
shall publish on the Portal on management of medical devices[581] planned contents and form of
advertising.
5. The registration number holder[582] or the entity authorized in writing
by the registration number holder[583]
shall assume legal responsibility for the conformity of advertisement contents
with the published ones and the application for declaration of applied
standards of Class-A or Class-B medical device[584] or the application for registration
of Class-C or Class-D medical device[585].
6. Documents or materials that do not contain name
of a medical device[586],
those that contain name and technical specifications of the medical device[587] but do not
contain functions or uses of the medical device, scientific research documents,
clinical documents, and documents used for training in use of a medical device
shall not be considered as advertising documents.
Chapter X
MANAGEMENT AND USE OF MEDICAL DEVICES[588] BY HEALTH FACILITIES
Article 63. Rules for management and use of
medical devices[589]
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2. Medical devices[591] shall be stored, maintained and used
in accordance with the manufacturer's instructions, and must undergo quality in
accordance with regulations of this Decree.
With regard to medical devices[592] subject to strict occupational safety
and health requirements, regulations of the Law on occupational safety and
health must be strictly complied in addition to regulations on quality control
laid down in this Decree.
3. Documents on medical devices[593] must be adequately prepared, managed
and retained; medical devices[594]
shall be sufficiently and punctually recorded according to their actual state
and values in accordance with regulations of laws on accounting and statistics
and other relevant laws; funding for performing tasks prescribed in Clause 2 of
this Article must be ensured.
4. Health facilities shall bear inspection of
regulatory authorities in charge of managing medical devices[595].
Article 64. Management and use of medical devices[596] by State-owned
health facilities
In addition to the provisions on management and use
of medical devices[597]
in Article 63 of this Decree, State-owned health facilities shall manage medical
devices[598]
according to the following provisions:
1. Investment in, purchase, management and use of
medical devices[599]
shall comply with regulations of law on management and use of public assets.
2. Use of domestically manufactured medical devices[600] are encouraged.
Article 65. Rights and responsibilities of
health facilities for management and use of medical devices[601]
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a) Request the registration number holder or the
warranty center recognized by the product owner[602] to provide periodical maintenance of
medical device during the warranty period;
b) Request the seller to provide technical
documents of the medical device[603];
c) Receive the used medical devices[604] to serve their
scientific research and training in use and repair of medical devices[605].
2. Each health facility shall have the following
responsibilities:
a) Use and operate the medical device[606] according to
instructions of the product owner[607];
b) Carry out periodical maintenance, inspection and
calibration according to instructions of the product owner[608] or as prescribed by law;
c) Participate in testing for and assessment of
quality of medical devices[609];
d) Submit reports on defective medical devices[610] and provide
other information at the request of competent authorities.
Chapter XI
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Article 66. Online procedures
1. Declaration of eligibility for manufacture of
medical devices[611].
2. Declaration of applied standards for medical
devices[612].
3. Application for registration of medical device [613].
4. Declaration of eligibility for medical device[614] trading.
5. Declaration of eligibility to provide medical
device[615]
technical consulting.
6. Application for certificate of registration of
medical device[616]
inspection services.
7. Application for license to import medical
devices[617].
8. Application for Certificate of Free Sale for
domestically manufactured medical device[618].
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10. Declaration of concentration/content of raw
materials for manufacture of medical devices[620] and substances for external quality
assessment that contain narcotic substances and precursors.
11. Declaration of contents and form of advertising
of medical device[621].
12. [622] If any document required for
completing procedures specified in this Decree must be treated as confidential,
it shall be submitted in person and managed in accordance with regulations on
management of confidential documents.
Article 67. Requirements for online application
An application for declaration, registration,
issuance of license or CFS submitted online (hereinafter referred to as “online
application”) shall be considered valid when it meets the following
requirements:
1. It contains adequate documents which are
prepared according to regulations applicable to a physical application and
converted into electronic documents. The name of an electronic document must be
relevant to the name of the physical document.
2. Information on declaration, application for
registration or license is complete and accurate.
Article 68. Procedures for online declaration
1. The legal representative or his/her authorized
person shall declare information, upload electronic documents, make certification
using digital signature (if any) and make online application fee payment
according to procedures on the Portal on management of medical devices[623].
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3. Results of online administrative procedures
shall have the same legal effect as those of normal administrative procedures.
Article 69. Retention of online application
1. When submitting an online application, the
applicant is required to retain physical documents of that application in
accordance with Clause 1 Article 33 of this Decree.
2. In case any physical document included in the
application specified in Clause 1 of this Article is lost or damaged, the
applicant shall give a written notice to the receiving authority, reprepare
that document and notify the receiving authority in writing of their completion
of application, and then follow procedures for updating their application after
obtaining an approval from the receiving authority.
3. Within 35 days from the receipt of the written
notice of the loss of document, if the applicant fails to give a written notice
of their completion of application, the receiving authority shall:
a) Remove all information published on the Portal
about the medical device[624]
manufacturer, medical device[625]
trading establishment or consultant on medical device[626] technology, raw materials for
manufacture of medical devices[627],
substances for external quality assessment that contain narcotic substances and
precursors, medical device[628]
inspection service provider, and registration number of the medical device;
b) Revoke the registration number and license to
import medical devices[629].
4. The applicant shall stop their operation and
placement of the relevant medical device[630] on the market from the day on which
the information is removed as prescribed in Clause 3 of this Article.
Chapter XII
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Article 70. Responsibilities of Ministry of
Health
The Ministry of Health shall assume responsibility
before the Government for state management of medical devices[631] and have the following tasks and
powers:
1. Submit to the Government or Prime Minister to
promulgate, or promulgate within their jurisdiction, legislative documents,
national technical regulations, strategies, policies and plans on medical
devices[632].
2. Direct and organize the implementation of
legislative documents, national technical regulations, strategies, policies and
plans on medical devices[633].
3. Organize information dissemination and
communication on medical devices[634].
4. Provide training for human resources in the
field of medical devices[635].
5. [636] Publish the following information on
its web portal:
a) Successful bids for procurement of medical
devices[637] by
state-owned health facilities nationwide;
b) List of medical devices[638] whose registration number has been
revoked;
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6. Decide whether or not to apply provisions of
this Decree to products or goods are considered as medical devices[640] in some
countries but may not be considered as such medical devices[641] in other countries.
7. [642] Play the leading role and cooperate
with regulatory authorities in conducting inspections, settling
complaints/denunciations and taking actions against violations related to
medical devices[643]
in accordance with regulations of this Decree and relevant laws.
8. Update and publish the list of organizations
specified in Point a Clause 2 Article 29 of this Decree.
9. Provide detailed regulations on classification
of medical devices[644]
which must be conformable with ASEAN’s treaties on classification of medical
devices[645] to
which Vietnam is a signatory; issue practical training programs in
classification of medical devices[646].
10. Issue the list of medical devices[647] subject to
inspection and class-based inspection procedures for listed medical devices[648].
11. Provide guidelines for preparation of ASEAN
Common Submission Dossier Template (CSDT) on medical devices[649].
12. Provide specific provisions on templates used
during the implementation of this Decree.
13. [650] Publish and revise the list of
medical devices[651]
subject to compulsory price declaration to meet management requirements and
actual situations.
14. [652] Give guidelines for information on
medical devices[653]
subject to compulsory price declaration.
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1. Issue the list of medical devices[654] which are
measuring devices subject to sample approval, inspection and calibration after
obtaining the consent from the Ministry of Health.
2. Play the leading role and cooperate with the
Ministry of Health in formulating national standards for medical devices[655]; quality
inspection of medical devices[656]
that are measuring devices and radiation equipment.
Article 72. Responsibilities of Ministry of
Finance
1. Provide guidelines for management of public
assets that are medical devices[657]
by State-owned health facilities after obtaining opinions from the Ministry of
Health.
2. Provide specific provisions on management and
use of fees and charges in the field of medical devices[658] in accordance with regulations of law
on fees and charges.
3. Carry out inspection and take actions against
violations in the field of medical devices[659].
Article 73. Responsibilities of provincial
People's Committees
1. Bear responsibility to manage activities
relating to trading and use of medical devices[660] in the province.
2. Organize information dissemination and
communication on medical devices[661]
in the province.
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4. Publish on the Portal of the provincial People's
Committee and send to the Ministry of Health the following information:
a) Successful bids for medical devices[663] of State-owned
health facilities in the province.
b) List of medical devices[664] whose registration number has been
revoked in the province.
5. [665] Take responsibility to organize and
process procedures as prescribed in this Decree; organize inspections, settle
complaints/denunciations and take actions against violations related to medical
devices[666] and
prices of medical devices[667]
in their provinces in accordance with regulations of law.
Article 74. Responsibilities of medical device
traders[668]
1. Medical device[669] traders shall assume responsibility
for safety and quality of their medical devices[670].
2. Domestic medical device[671] manufacturers shall assume
responsibility to manage quality of medical devices[672] during manufacture, transport and
storage of medical devices[673]
according to their applications for registration number.
3. Registration number holders shall:
a) Carry out classification of medical devices[674], publish on the
Ministry of Health’s Portal and assume legal responsibility for their
classification results;
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b) Follow procedures for declaration of applied
standards or application for registration of medical devices[676] in accordance with this Decree.
Assume legal responsibility for the accuracy and truthfulness of their
applications for registration number;
c) Establish and maintain operation of warranty
centers for medical devices[677]
or enter in service contracts with qualified medical device[678] warranty service providers, except
disposable medical devices[679]
as defined by product owners[680]
or cases where there are documents proving that the medical device is not under
warranty;
d) Prepare and keep documents on management of
medical devices[681]
and carry out tracing of origin of medical devices[682] as prescribed in this Decree, except
disposable medical devices[683]
as defined by product owners[684];
submit reports to police authorities on loss of medical devices or raw
materials for manufacture of medical devices that contain narcotic substances
and precursors;
dd) Provide adequate and accurate information about
the product on the label and user manual of the medical devices[685] in accordance
with regulations of law on goods labels and provisions of this Decree;
e) Issue prompt, adequate and accurate warnings
about risks to users’ health and the environment; instructions for sellers and
users on how to minimize the risks; provide information about requirements for
transport, storage and use of medical devices[686];
g) Promptly stop placement on the market, take
corrective actions against or recall defective medical devices[687] in accordance with this Decree, and
notify relevant parties. Destruction of defective medical devices[688] shall comply
with regulations of law on environmental protection and relevant laws; the
destruction costs shall be paid by the registration number holder;
h) Comply with regulations of law and inspection
decisions issued by competent authorities;
i) Pay compensation for damage caused by defective
medical devices[689]
as prescribed by law;
k) Ensure that the following documents are
effective during the effective period of the registration number:
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- The authorization letter, except the case
specified in Point a Clause 1 Article 25 of this Decree;
- Certificate of eligibility to provide warranty
services, except disposable medical devices[691] defined by product owners[692] or cases where
there are documents proving that the medical device is not under warranty.
l) Ensure that the medical devices[693] are only manufactured during the
effective period of the certificate of conformity with quality control
standards;
m) Take legal responsibility for the legitimacy and
accuracy of the documents posted while following the procedures specified in
this Decree;
n) Provide every health facility that buys the
medical devices[694]
with 01 set of quality control documents on such medical devices[695] specified in
Clause 4 Article 33 of this Decree;
o) [696]
Post and declare prices of medical devices[697] in accordance with the provisions of
this Decree and the law on pricing.
p) Perform other obligations as prescribed by law.
4. Traders, exporters, importers and transferors of
medical devices[698],
raw materials, or substances for external quality assessment that contain
narcotic substances and precursors shall submit annual reports to the Ministry
of Health and Ministry of Public Security by January 15 of the following year.
5. [699] When submitting applications for
handling of procedures as prescribed in this Decree, the applying organizations
or individuals shall:
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b) ensure the consistency and conformity of
information on medical device[700]
provided in the initially submitted request or application with that provided
in documents additionally submitted at the request of competent authorities;
c) ensure the validity of submitted documents
during the handling of procedures;
d) retain documents included in their submitted
applications.
Chapter XIII
IMPLEMENTATION
Article 75. Effect[701]
1. This Decree comes into force from January 01,
2022.
2. The following Decrees cease to have effect from
the effective date of this Decree, including:
a) The Government’s Decree No. 36/2016/ND-CP dated
May 15, 2016 on management of medical devices[702];
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c) The Government’s Decree No. 03/2020/ND-CP dated
January 01, 2020 providing amendments to Article 68 of the Government’s Decree
No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices[704], as amended by
the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018 providing
amendments to the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on
management of medical devices[705].
3. Article 7 of the Government’s Decree No.
181/2013/ND-CP dated November 14, 2013 shall be abrogated from July 01, 2022.
Article 76. Transition[706]
1. Applications for issuance of registration number
which have been submitted according to the provisions of the Government’s
Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices[707], as amended in
the Government’s Decree No. 169/2018/ND-CP and the Government’s Decree No.
03/2020/ND-CP (hereinafter referred to as “Decree No. 36/2016/ND-CP”) before
January 01, 2022 but have not been yet processed by the effective date of this
Decree shall be processed as follows:
a) With regard to an application for registration
of Class-B medical device[708],
the Ministry of Health of Vietnam shall instruct the applicant to review the
submitted application and follow procedures for declaration of applied
standards in accordance with this Decree without paying additional fee;
b) With regard to an application for registration
of Class-C or D medical device[709],
the Ministry of Health of Vietnam shall issue registration number according to
Article 32 of this Decree if it meets all of the requirements laid down in
Clause 3 Article 30 of this Decree;
c) The medical device[710] classification result given by a
classification body eligible to classify medical devices[711] before the effective date of this
Decree may be used.
2. Regulations on validity of import license;
import of medical devices[712]
which are not included in the list of medical devices[713] subject to import license
requirements:
a) An import license for medical devices[714] other than IVD
reagents which is issued within the period from January 01, 2018 to December
31, 2021 shall remain valid until December 31, 2024 inclusively;
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c) Holders of import license prescribed in Point a
and b of this Clause shall meet relevant eligibility requirements laid down in
laws and assume responsibility for quality, quantity, categories and uses of
their imported medical devices[716].
The Ministry of Health of Vietnam shall carry out inspections and consider
revoking the import license in case of violations against regulations on
management of medical devices[717];
d) The import of medical devices[718] which are not subject to import
license requirements (except insecticidal and germicidal chemicals and
preparations for medical and household use which are used for disinfection of
medical devices[719]
only) and have been classified as Class-C or D medical devices[720] as published on the web portal of the
Ministry of Health of Vietnam may continue until the end of December 31, 2024
without limits on import quantities and requiring the Ministry of Health of
Vietnam’s confirmation as medical devices[721], regardless of the time of publishing
information on such medical devices on the web portal of the Ministry of Health
of Vietnam.
When following import procedures, the importer
shall declare the number of document indicating medical device[722] classification results given by
itself or by a qualified classification body and shall assume
responsibility for quality, quantity, categories and uses of imported medical
devices[723].
Customs authorities shall verify the document
indicating medical device[724]
classification results declared by the importer on the web portal of the
Ministry of Health of Vietnam.
3. Regulations on validity of registration number,
certificate of registration of medical device, and number of certificate of
registration of medical device:
a) Registration numbers issued according to the Decree
No. 36/2016/ND-CP before January 01, 2022 shall remain valid indefinitely;
b) Certificates of registration of domestically
manufactured medical devices[725]
issued before January 01, 2022 shall remain valid until the expiry dates
thereon;
c) Registration numbers of medical devices[726] which are IVD
reagents issued within the period from January 01, 2014 to December 31, 2019
shall remain valid until December 31, 2024 inclusively;
d) Registration number issued to medical devices[727] that are IVD
reagents within the period from January 01, 2020 to December 31, 2021 shall
remain valid until the expiry dates on issued certificates of registration;
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4. Regarding applications for import license for
medical devices[730]
which have been submitted before January 01, 2022 but have not been yet
processed:
The Ministry of Health of Vietnam shall inform and
request applicants to complete their applications for registration number
according to the provisions of the Decree No. 98/2021/ND-CP and prioritize the
processing of such applications. If the applicant wants to obtain an import
license according to the submitted application, the Ministry of Health of
Vietnam shall issue the import license according to the sequence and procedures
in Point c of this Clause if the submitted application is adequate and meets the
requirements laid down in Point a or b of this Clause.
a) An application for import license for a medical
device[731]
included in the list of medical devices subject to import license requirements
published by the Minister of Health of Vietnam shall include:
- The application form for import license;
- The unexpired CFS of the category of medical
device[732] to be
imported (original copy or certified true copy);
- The manufacturer’s unexpired certificate of
conformity with ISO 13485 quality control standards (the original or copy
bearing the applicant’s certification);
- The unexpired power of attorney given by the
product owner[733]
to the importer of the medical device[734] (the original or certified true copy);
- Technical file describing the category of
imported medical device[735]
in Vietnamese (bearing the applicant’s certification);
- Catalogue describing functions and technical
specifications of category of imported medical device[736];
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b) An application for import license for IVD
reagents shall include:
- Import order;
- The unexpired CFS (original copy or certified
true copy);
- The manufacturer’s unexpired certificate of
conformity with ISO 13485 quality control standards (the original or copy
bearing the applicant’s certification);
- Standards and methods for quality inspection of
medical device[738]
(bearing the applicant’s certification);
- Label and user manual in Vietnamese accompanied
with original label and user manual (bearing the applicant’s certification).
c) Procedures for granting import license:
- If the application for import license does not
need to be modified, the Ministry of Health of Vietnam shall issue the import
license. If the application for import license is refused, a written response
indicating reasons for refusal shall be given;
- If the application for import license needs to be
modified, the Ministry of Health of Vietnam shall send a request to the
applicant for modification, in which documents and/or contents to be modified
must be indicated;
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Over 60 days from the receipt of the request for
modification from the Ministry of Health of Vietnam, if the applicant fails to
submit the modified application or the application is still unsatisfactory
after 03 modification times, the Ministry of Health of Vietnam shall refuse to
issue the license to import medical devices[739];
d) An import license issued according to the
provisions of this Clause shall be valid until December 31, 2024, inclusively.
5. Regulations on application of ASEAN Common
Submission Dossier Template (CSDT) on medical devices[740]: CSDT is compulsory from January 01,
2024.
6. Applications for issuance of registration number
submitted before January 01, 2024 as prescribed in Article 30 of this Decree:
a) An application for issuance of registration
number shall include the documents specified in Article 30 of this Decree of
which CSDT document and report on CSDT document validation in Point c Clause 5
Article 30 of this Decree shall be replaced with the following documents:
- The synopsis of technical description of the
medical device[741]:
the copy in Vietnamese accompanied by technical documents describing functions
and specifications of the medical device[742] issued by the product owner[743] and bearing the
applicant’s certification shall be submitted. For in-vitro reagents,
calibrators and control materials: the synopsis of technical description in
Vietnamese must be accompanied by documents stating materials and safety of the
product, manufacturing process, pre-clinical and clinical trial reports
including stability reports;
- The user manual for medical device[744]: the copy in
Vietnamese bearing the applicant’s certification, accompanied by the original
copy in English issued by the product owner[745] in case of imported medical device[746];
- Sample of the label for the medical device[747] sold in
Vietnam: The sample label bearing the applicant’s certification is submitted.
The sample label must meet requirements laid down in regulations of law on
labeling of goods.
b) The receipt and processing of applications for
registration of medical devices[748]
prescribed in Clauses 1, 2, 3 and 4 Article 30 of this Decree shall comply with
the provisions of Article 32 of this Decree.
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- If the application does not need to be modified,
the Minister of Health of Vietnam shall process the application and consider
issuing the registration number within 90 days from the receipt of the adequate
and valid application (including application fee receipt as prescribed by the
Ministry of Finance). If the application is refused, a written response
indicating reasons for refusal shall be provided;
- If the application needs to be modified, the
Ministry of Health of Vietnam shall send a request for modification, in which
such documents and contents requiring modification must be specified, to the
applicant that is required to send the modified application to the Ministry of
Health of Vietnam within 60 days from the receipt of the request;
- The applicant shall comply with the request for
modification and send the modified application to the Ministry of Health.
If the modified application is still
unsatisfactory, the Ministry of Health of Vietnam shall continue sending a
request for modification to the applicant to modify the application as
prescribed in this Clause.
If the applicant fails to provide the modified
application within 90 days from the receipt of the Ministry of Health’s request
for modification or the application is still unsatisfactory after 03
modification times, the application shall be rejected.
7. The application of the following regulation:
“Prohibition of trading in medical devices[750] before their prices are declared or
at prices higher than those available on the Ministry of Health’s web portal at
the time of trading” is optional with respect to contract packages for bid
opening is made before April 01, 2022.
8. Regarding contract packages for purchase of
medical devices[751]
for which the supplier selection plans have been approved before the effective
date of this Decree but bidding documents have yet to be published or issued,
the modification of supplier selection plans in respect of price-related
contents shall comply with regulations of law on bidding if it is deemed
necessary.
Article 77. Responsibility for guidance and
implementation
1. The Minister of Health of Vietnam shall
instruct, organize and inspect the implementation of this Decree.
...
...
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CERTIFIED BY
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
Form 10 - Application for approval of clinical
trial made by organization or individual whose medical device is subject to
clinical trial [752]
[NAME OF
APPLICANT]
-----
THE SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
-----------------
No. ... /…….Re:
application for approval of clinical trial for medical device
...
...
...
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To: The Ministry of
Health of Vietnam.
Organization/individual owning the medical device:
……………………………………………
ID number/number of citizen identity card or
identity card/personal identification number/ passport number1:
……………………………………………………
Business address: …………………………………………………………………………………
Telephone number: …………………………………… Fax:
……………………………………
Email: ………………………………………………………………………………………………
We hereby submits this letter to the Ministry of
Health of Vietnam to apply for an approval of clinical trial for medical device
with the details as follows: ……………………………………………………………………………………………….
Clinical trial phase:
………………………………………………………………………………
...
...
...
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Type: ……………………………………………………………………………………………
Class of medical device:
………………………………………………………………………
Name of the manufacturer:
……………………………………………………………………
Address of the manufacturer: …………………………………………………………………
Proposed clinical trial institution:
………………………………………….
Address: …………………………………………………………………………………………
Telephone number: …………………………………… Fax: …………………………………
Email: ……………………………………………………………………………………………
Full name of the principal investigator:
………………………………………………………
...
...
...
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Telephone number: …………………………………… Email:
…………………………………
Attached documents: 3
1. ……………………………………………………………………………………………
2. ……………………………………………………………………………………………
3. ……………………………………………………………………………………………
The organization/individual owning the medical
device and the principal investigator hereby undertake that there is no
conflict of interest between parties participating in the trial, and we shall
properly conduct the clinical trial approved by the Ministry of Health of
Vietnam and strictly comply with good clinical practices and other regulations
on clinical trial for medical devices.
PRINCIPAL
INVESTIGATOR
(signature and full name)
REPRESENTATIVE
OF ORGANIZATION/INDIVIDUAL OWNING MEDICAL DEVICE
(signature, full name and seal)
...
...
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1Specify any of ID number/number of
citizen identity card or identity card/personal identification number/
unexpired passport number.
2Specify any of ID number/number of
citizen identity card or identity card/personal identification number/
unexpired passport number.
3List all documents attached to the
application form. All documents must be complete and arranged in the order
prescribed in the Decree No. 96/2023/ND-CP.
Form 11 - Application for approval of clinical
trial made by clinical trial institution [753]
[NAME OF
APPLICANT]
-----
THE SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
-----------------
No. … / …….Re:
application for approval of clinical trial for medical device
Hanoi, on ... ...
... ...[date]
...
...
...
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To: The Ministry of
Health of Vietnam.
Name of the clinical trial institution:
Address:
Telephone number:
Fax:
Email:
Full name of the principal investigator:
ID number/number of citizen identity card or
identity card/personal identification number/ passport number1:
……………………………………………………
Telephone number:
Email:
Organization/individual owning the medical device:
...
...
...
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Business address:
Telephone number:
Fax:
Email:
We hereby submits this letter to the Ministry of
Health of Vietnam to apply for an approval of clinical trial for medical device
with the details as follows: ……………………………………………………………………………………………….
- Clinical trial phase:
- Name of medical device:
- Type:
- Class of medical device:
- Name of the manufacturer:
...
...
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- Name of the product owner:
Attached documents: 3
1. ………………………………………………………………………………………………
2. ………………………………………………………………………………………………
3. ………………………………………………………………………………………………
We kindly request the Ministry of Health of Vietnam
to consider and give approval of the clinical trial for medical device
mentioned above.
The clinical trial institution and the principal
investigator hereby undertake that there is no conflict of interest between
parties participating in the trial, and we shall properly conduct the clinical
trial approved by the Ministry of Health of Vietnam and strictly comply with
good clinical practices and other regulations on clinical trial for medical
devices.
PRINCIPAL
INVESTIGATOR
(signature and full name)
...
...
...
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HEAD OF THE
CLINICAL TRIAL INSTITUTION
(signature, full name and seal)
_________________
1Specify any of ID number/number of
citizen identity card or identity card/personal identification number/
unexpired passport number.
2Specify any of ID number/number of
citizen identity card or identity card/personal identification number/
unexpired passport number.
3List all documents attached to the
application form. All documents must be complete and arranged in the order
prescribed in the Decree No. 96/2023/ND-CP.
Form 12 - Description of clinical trial protocol
for medical device[754]
MINISTRY OF
HEALTH OF VIETNAM
Description of clinical trial protocol for medical device
I. General information on the clinical trial for
medical device
...
...
...
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2. Code (provided by the supervisory authority)
3. Trial period:
(From ……. (month/year) to.......
(month/year))
4. Level of supervisory authority
State
□
Ministry/Provincial government □
5.
Funding
Total:
...
...
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(clearly indicate source of funding:
funding for science and technology, donations, equity, etc.)
6
Planned trial phase:
7
Principal investigator:
Full name:
Academic degree/title:
...
...
...
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Telephone
number:
(Office)/
(Home)
Fax:
Mobile:
E-mail:
Office’s address:
Home address:
8
The clinical trial institution:
Name of the clinical trial institution:
Telephone
number:
Fax:
Email:
...
...
...
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9
Organization/individual whose medical device is
subject to the clinical trial (is the one entitled to the copyright for the
medical device undergoing the clinical trial and use the clinical trial
result for initiating manufacture of the medical device or put the medical
device into use or following trial phase).
Name of organization
Telephone
number:
Fax:
E-mail:
Office’s address:
Full name (of individual):
Academic degree/title:
Scientific title:
Telephone
number:
(Office)/
(Home)
Fax:
...
...
...
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E-mail:
Office’s address:
Home address:
II. Contents of clinical trial for medical
device
10
Objectives:
11
...
...
...
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□ Theme’s
status □
New □
Follow the theme finished in the previous phase
□ Description of the medical device
(manufacturing technology, technical functions, quality of product, process
of use or operation, evaluation method, potential risks and measures for
protecting safety of participants and assessors/investigators and other
relevant contents)
□ Overview of the clinical trial for medical
device:
Foreign trial:
Domestic trial:
□ List of relevant clinical trials for medical
device announced within the last 10 years.
12
...
...
...
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12.1 Trial site:
12.2 Trial period:
12.3 Study method: Describe type of evaluation
(randomized, blinded, unblinded), design of evaluation (parallel groups,
matched-pair technique), blinding techniques (single-blind and double-blind
techniques), method and process of random sampling.
12.4 Trial participants: Describe the trial
participants (standards of participants and exclusion of potential
participants), standard operating procedures (SOPs) for the selection of
trial participants; method, standards and time of dividing trial participants
into study groups.
12.5 Sample size: Number of participants required
to achieve the evaluation objectives based on statistical calculations.
12.6 Medical device undergoing clinical trial:
Brief description of the medical device undergoing the clinical trial,
including name, type of the medical device, applied technology, main
specifications, clinical indications and uses. Specific information on the
batch of medical devices used in the trial: name, manufacturer, batch number,
date of manufacture, expiry date, and proofs of quality control. Packing,
labeling, storage, preservation, transport, instructions for use and
attentions during use of the medical device. Analyses and assessment of level
of risks/benefits from use of the medical device, potential adverse events of
the medical device and safety measures appropriate to patients/trial
participants, and healthcare workers.
12.7 Procedures for use of the medical device
(develop standard operating procedure - SOPs): Clearly describe and state the
use process (use methods and ways, intended users, etc.), diagnosis and
treatment periods; person in charge of performing steps of the procedure; evaluation
criteria and indicators.
12.8. Combination therapy: Any other therapies
that could have been defined or allowed to be used at the same time.
12.9 Trial data and collection method.
...
...
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12.11 Methods for handling adverse events
12.12 Criteria for excluding participants from
the trial: Exclusion criteria for participants and instructions for
termination of the entire or part of the clinical trial.
12.13 “Blinding” technique and protection of
identity of trial participants: Procedures for maintaining list of
participant identifiers, treatment coefficient, list of randomly selected
participants and/or case report forms (CRFs). These documents must
allow identification of each patient or participant as well as data
inspection and acquisition.
12.14 Provisions on code breaking: Information on
setting up of trial codes, place for storing lists and who is allowed to
perform code breaking, when and how the code is broken in cases of emergency.
12.15 Methods of data processing and assessment
of results: Describe the methods used for assessing results (including
statistical methods) and reports on patients or participants dropping out of
the trial.
12.16 Methods for providing information for
participants: Information provided for participants include how they will be
provided with information on the trial, when and how their participant
information sheet and consent forms will be collected.
12.17 Training for clinical trial staff: Provide
training for investigators participating in the clinical trial (including
principal investigator, coordinator, investigators, pharmacists, nurses,
technicians, etc.), including: basis contents of the trial, information on
methods for evaluation, SOPs on management and use of the medical device,
management and use of accompanied products in the trial regimen.
12.18 Ethical issues: Ethical considerations and
measures related to the trial (including methods and procedures for selecting
participants, participant information sheet and consent form, and commitments
to comply with ethical guidelines for clinical trial).
12.19 Post-trial healthcare: Healthcare provided
after the trial and treatment methods applied after the trial.
...
...
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12.21 Plan for monitoring, supervision and
inspection:
- Supervision of principal investigator and other
investigators
- Supervision of sponsors/organization or
individual owning the medical device subject to the clinical trial
- Supervision and inspection by supervisory
authorities and Research Ethics Committee.
12.22. SOPs for the clinical trial
Ethical issues in biomedical research:
(Including participant information sheet
and consent form, and commitments to comply with ethical guidelines for
clinical trial).
13
Contents of the clinical trial (list and describe
all contents of the trial, highlight the contents which are new and suitable
for resolution of issues set out and achieving the stated trial objectives,
including planned activities of cooperation in transferring trial results to
users)
...
...
...
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- Task 1:
- Task 2:
- ………….
13.2. Content 2:
- Task 1:
- Task 2:
- ………….
………….
14
...
...
...
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Name of partner
Contents of
cooperation
15
Implementation schedule
No.
Main contents
and tasks
(main evaluation milestones)
...
...
...
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Duration
(starting time - completion time)
In charge
person/authority
1
2
3
4
5
...
...
...
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...
...
...
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III. Results of the clinical trial
16
Expected results
□ Diagram
□ Data sheets
□ Analytical reports, conclucions on efficacy,
suitability and safety of the medical device
□ Forecasts for the next phase of the clinical
trial
...
...
...
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□ Use process
□ Other products
17
Product requirements
No.
Product’s name
Scientific
requirements
Notes
(1)
...
...
...
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(3)
(4)
1
2
...
...
...
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3
18
Methods for transfer of the trial results
19
Impacts of the trial results (in addition to
those mentioned in section 18)
...
...
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□ For relevant scientific fields:
□ For society and economy:
IV. Organizations/individuals participating in
clinical trial for medical device
20
Activities of organizations cooperating in
clinical trial
(specify all cooperating organizations and
their in-charge activities)
No.
Name of
organization
Address
...
...
...
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1
2
3
...
...
...
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…
21
Connection with manufacture and life
(specify manufacturers or users of trial
results who have participated in the trial and their in-charge activities)
...
...
...
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Personnel participating in the trial
(specify information on persons making
major contributions of all clinical trial institutions and
institutions/organizations cooperating in conducting the clinical trial)
No.
Full name
Working place
Percentage (%)
of working period for the trial
A
Principal investigator
...
...
...
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B
1
2
…
Investigators
V. Funding for the clinical trial and funding
sources
(provide detailed explanations according to
the Appendix enclosed herewith)
...
...
...
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23
Funding for the trial sorted by type of
expenditures
No.
Funding sources
Total
Including
Piecework-based
professional services
Raw materials,
energy
Equipment,
machinery
...
...
...
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Others
1
2
3
4
5
6
7
8
...
...
...
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Total funding
Including:
State budget-derived funding for scientific
activities
Other funding sources (specify)
- Equity
- Others (mobilized capital, etc.)
...
...
...
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1
2
HEAD OF CLINICAL TRIAL INSTITUTION
(signature, full name and seal)
......
[location & date]
PRINCIPAL INVESTIGATOR
(signature and full name)
...
...
...
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……….. [location
& date]
DIRECTOR
OF ADMINISTRATION OF SCIENCE, TECHNOLOGY AND TRAINING
ESTIMATED COSTS
OF THE CLINICAL TRIAL
Unit: VND million
No.
Expenditures
Total
Funding source
Funding
...
...
...
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State
budget-derived funding for scientific activities
Donations
Others
1
Piecework-based professional services
...
...
...
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2
Raw materials, energy
3
Specialized equipment and machinery
...
...
...
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4
Construction, minor repairs
...
...
...
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5
Others
Total
...
...
...
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Explanations
about expenditures
(VND million)
Item 1. Piecework-based professional services
No.
Description
Total funding
...
...
...
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State
budget-derived funding for scientific activities
Donations
Others
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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Total
...
...
...
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Item 2. Raw materials, energy
No.
Description
Unit
Quantity
Unit price
Amount
...
...
...
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State
budget-derived funding for scientific activities
Donations
Others
2.1
Raw materials
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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2.2
Tools, spare parts
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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2.3
Energy and fuels
...
...
...
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- Coal
...
...
...
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- Electricity
kW/h
...
...
...
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- Oil and gas
...
...
...
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- Other fuels
...
...
...
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Water
m3
2.5
...
...
...
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Total
...
...
...
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Item 3. Specialized equipment and machinery
No.
Description
Unit
Quantity
Unit price
Amount
...
...
...
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State
budget-derived funding for scientific activities
Donations
Others
3.1
Purchase of technology equipment
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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3.2
Purchase of evaluation and measuring equipment
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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3.3
Depreciation
...
...
...
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...
...
...
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...
...
...
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...
...
...
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3.4
Leased equipment
...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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...
...
...
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3.5
Transport and installation
...
...
...
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...
...
...
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...
...
...
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...
...
...
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Total
...
...
...
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Item 4. Construction, minor repair
No.
Description
Funding
Funding source
State
budget-derived funding for scientific activities*
Donations
Others
4.1
...
...
...
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4.2
Repair of …..m2 of workshop/laboratory
...
...
...
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4.3
Installation of electrical and water systems
4.4
Other expenses
...
...
...
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...
...
...
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Item 5. Others
No.
Description
Funding
Funding source
...
...
...
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Donations
Others
5.1
Business trip expenses
...
...
...
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...
...
...
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5.2
Administration expenses
...
...
...
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5.3
Costs of evaluation, inspection and acceptance
testing
...
...
...
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- Appraisal and approval of documents
...
...
...
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- Supervision costs
- Costs of intermediate inspection and acceptance
testing
...
...
...
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- Costs of internal acceptance testing
...
...
...
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5.4
Others
...
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- Training
- Conferences
...
...
...
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- Printing of documents, office stationery
...
...
...
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….
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5.5
Allowances for investigators
Total
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*Note: NSSNKH - State budget-derived
funding for scientific activities.
Form 13 - Application for approval of changes in
clinical trial for medical device[755]
[NAME OF
APPLICANT]
-----
THE SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
-----------------
No. …/…..Re:
application for approval of changes in clinical trial
Hanoi, on ... ...
... ...[date]
...
...
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To: The Ministry of
Health of Vietnam
Name of the clinical trial institution:
………………………………………………………
Name of organization/individual that owns the
medical device undergoing the clinical trial: ………………………………………
Full name of the principal investigator:
…………………………………………………………
Number of ID card or Passport:
…………………………………………………………………
Telephone number: ……………………………………… Email:
………………………………
The Ministry of Health of Vietnam has granted
approval of the clinical trial for the medical device [name of the trial] under
the Decision No. /QD-BYT dated………..
We hereby submit this letter to apply for approval
of the following changes:
No.
...
...
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Explanation on
change
List of
documents concerning the change
1.
2.
...
...
...
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3.
Attached documents: 1
1. ……………………………………………………………………………………………………
2. ……………………………………………………………………………………………………
3. ……………………………………………………………………………………………………
After studying the Decree No. 98/2021/ND-CP on
management of medical devices, the Decree No. 96/2023/QD-CP elaborating the Law
on Medical Examination and Treatment and relevant regulations, we hereby
declare that we will fully comply with relevant legislative documents and
professional regulations as well as codes of ethics for clinical trials. We
kindly request the Ministry of Health (via the Administration of Science
Technology and Training) to consider granting approval of our abovementioned
changes.
...
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PRINCIPAL
INVESTIGATOR
(signature and full name)
HEAD OF THE
CLINICAL TRIAL INSTITUTION
(signature, full name and seal)
REPRESENTATIVE
OF ORGANIZATION/INDIVIDUAL OWNING MEDICAL DEVICE UNDERGOING CLINICAL TRIAL
(signature, full name and seal)
_______________________
1List all documents attached to the
application form. All documents must be complete and arranged in the order
prescribed in the Decree No. 96/2023/ND-CP.
Form 14 - Application for approval of results of
clinical trial for medical device[756]
[NAME OF
APPLICANT]
-----
...
...
...
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No. …/….Re:
application for approval of clinical trial results
Hanoi, on ... ...
... ...[date]
To: The Ministry of
Health of Vietnam.
The clinical trial institution:
Name of organization/individual that owns the
medical device undergoing the clinical trial:
Cooperating organization:
Principal investigator:
We kindly request the Ministry of Health of Vietnam
to consider giving approval of results of the clinical trial for medical
device:
...
...
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- Code of the clinical trial:
- Trial period:
- Clinical trial phase:
- Name of medical device:
- Type:
- Class of medical device:
- Name of the manufacturer:
- Address of the manufacturer:
- Name of the product owner:
...
...
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Attached documents:1
1. ……….……….……….……….……….……….……….……….……….……….……….
2. ……….……….……….……….……….……….……….……….……….……….……….
3. ……….……….……….……….……….……….……….……….……….……….……….
PRINCIPAL
INVESTIGATOR
(signature and full name)
HEAD OF THE
CLINICAL TRIAL INSTITUTION
(signature, full name and seal)
REPRESENTATIVE
OF ORGANIZATION/INDIVIDUAL OWNING MEDICAL DEVICE UNDERGOING CLINICAL TRIAL
(signature, full name and seal)
____________________________
...
...
...
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Form 15 - Report on results of clinical trial
for medical device[757]
Cover page 1
MINISTRY
OF HEALTH OF VIETNAM
REPORT ON
RESULTS OF CLINICAL TRIAL FOR MEDICAL DEVICE
...
...
...
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Classification of risks:
Code of the trial (if any):
Clinical trial phase:
Principal investigator:
The clinical trial institution:
Name of organization/individual that owns the
medical device undergoing the clinical trial:
Sponsor:
Level of supervisory authority: Ministry of Health
of Vietnam
...
...
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Total funding for the trial: ………………………. VND million
Including: Funding for scientific activities:
………………………. VND million
Other funding sources (if any) ………………………. VND
million
Year ……
Heading page
MINISTRY OF
HEALTH OF VIETNAM
...
...
...
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REPORT ON
RESULTS OF CLINICAL TRIAL FOR MEDICAL DEVICE
Name of the clinical trial:
Principal investigator:
The clinical trial institution:
Name of organization/individual that owns the
medical device undergoing the clinical trial:
Sponsor:
...
...
...
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Code of the trial (if any):
Trial period: (From month/year….. to month/year……)
Total funding for the trial: ………………………. VND million
Including: Funding for scientific activities:
………………………. VND million
Other funding sources (if any) ………………………. VND
million
Year …
...
...
...
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REPORT ON
RESULTS OF CLINICAL TRIAL FOR MEDICAL DEVICE
1. Name of the clinical trial:
2. Name of medical device:
3. Principal investigator:
4. The clinical trial institution:
5. Name of organization/individual that owns the
medical device undergoing the clinical trial:
6. Clinical trial phase:
...
...
...
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8. Clerk of the trial (if any):
9. Trial sites:
(a) Trial site 1
- Location:
- Principal investigator:
(b) Trial site 2
- Location:
- Principal investigator:
(c)
...
...
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11. Name of supervisor
12. Commitments on compliance with GCP requirements
13. Reporting date
Page 4
ABBREVIATIONS
TABLE OF CONTENTS
Part A. Abstract
...
...
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1. Preface:
1.1. Brief description of relevant domestic and
overseas trials
1.2. Urgency of the trial
1.3. Assumptions of the trial
1.4. Objectives of the trial
2. Overview of the trial:
2.1. Relevant trials in foreign countries
2.2. Relevant trials in Vietnam
3. Trial participants and study methods:
...
...
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3.2. Sampling, sample size and trial participants.
3.3. Study method.
3.3.1. Study indicators.
3.3.2. Methods for determining study indicators.
3.3.3. Specific study tools.
3.4. Data processing method.
4. Results of the clinical trial:
4.1. Brief description of the medical device
undergoing the trial, including intended function, type of device, technology,
characteristics and method of use.
4.2. Analysis of selected documents and data,
advantages and disadvantages.
...
...
...
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4.4. Evaluation of cultural, geographical and
demographic factors (e.g. age, ethnic group, sex, etc.).
4.5. Equivalent methods of device use according to
the same safety standards and considerations on ethical issues.
4.6. Summary of health status of the trial
participants.
5. Discussion:
6. Conclusion and recommendations:
7. References:
8. Appendixes (if any):…..
COMPULSORY
CONTENTS OF THE REPORT
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...
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2. Objectives of the trial.
3. Plans for conducting the clinical trials
3.1. Trial design and plan
3.2. Discussion on the trial design and selection
of control
3.3. Selection of the trial participants (target
population) (including standards of participants, and standards for exclusion
of participants from treatment or the trial)
3.4. The medical device undergoing the clinical
trial, accompanied devices/techniques/methods/treatment
regimen/medicines/products
3.5. Description of the method for ensuring data
quality
3.6. Statistical method specified in the clinical
trial protocol and determination of sample size
3.7. Changes occurring during the conduct of the
trial and analysis according to the plan.
...
...
...
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4.1. Current conditions of the trial participants
4.2. Variations compared to clinical trial protocol
5. Evaluation of the clinical trial results
5.1. Data analysis
Clearly determine patients/participants used in
analysis of the trial results and those excluded from the trial and causes
therefor.
5.2. Anthropological characteristics and other
basic characteristics
Provide a summary table of anthropological
characteristics of each patient
5.3. Determination of the suitability of the
medical device undergoing the clinical trial
Summarize and analyze any result of evaluation of
the suitability of each patient/participant for the medical device undergoing
the clinical trial.
...
...
...
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Analysis of treatment effectiveness.
Analysis/statistics.
Provide each patient’s response data sheet.
Method of use of the medical device undergoing the
clinical trial; technical procedures, dosage, usage of accompanied
devices/techniques/methods/treatment regimen/medicines/products, and the
relationship with treatment response.
Provide data of each patient.
Conclusions on treatment effectiveness.
6. Safety evaluation
Carry out analysis of data on the safety at 3
levels:
- Level of exposure () which needs to be inspected
to determine the safety of the trial.
...
...
...
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- Serious AEs and AEs that commonly occur in
participants/patients who must withdraw from the clinical trial ahead of the
required schedule, or participants/patients died, regardless of whether such a
serious AE is related to the medical device.
7. Level of exposure
The level of exposure needs to be evaluated on the
basis of the number of patients who received treatment with use of the medical
device, and implementation period.
8. Adverse effects (AEs)
- Summary of AEs.
- Description of AEs.
- Analysis of AEs.
- List of AEs sorted by patients/participants.
9. Deaths and other serious AEs
...
...
...
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- Report on deaths and SAEs (serious AEs), and
other AE symptoms.
- Analysis and discussion on deaths and SAEs
(serious AEs).
10. Evaluation of tests
- List test values of each patient/participant (as
prescribed in Appendix) and abnormal values.
- Evaluate each test parameter.
11. Vital signs, physiological symptoms and
other observations related to safety
Analyze vital signs, physiological symptoms and
observable changes.
12. Conclusions on safety
Re-state the level of safety of the medical device,
changes caused by dosage (if the medical device has accompanied products), AEs
resulting in termination of the use of medical device, required medical
interventions or death, etc.
...
...
...
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Evaluate the effectiveness and safety of the
medical device undergoing the clinical trial, relevance of benefits and risks.
14. Relevant tables, diagrams and charts
15. List of references
16. Appendixes: List appendixes included in
the report.
[1] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[2] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[3] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[4] The
Government’s Decree No. 07/2023/ND-CP dated March 03, 2023 providing amendments
to the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021
prescribing medical device management is promulgated pursuant to:
...
...
...
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And at the request of the Minister of Health of
Vietnam;”
The Government’s Decree No. 96/2023/ND-CP dated
December 30, 2023 on elaboration of the Law on Medical Examination and
Treatment is promulgated pursuant to:
“The Law on Government Organization dated
June 19, 2015; the Law on Amendments to the Law on Government Organization and
the Law on Local Government Organization dated November 22, 2019;
The Law on Medical Examination and Treatment
dated January 09, 2023;
And at the request of the Minister of Health of
Vietnam;”
[5] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[6] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[7] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[8] The
phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết bị y
tế” (without change in their meaning) as prescribed in clause 7 Article 147 of
the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[10]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[11]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[12]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[13]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[14]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[15]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[16]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[17]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[18]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[20]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[21]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[22]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[23]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[24]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[25]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[26]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[27]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[28]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[30]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[31]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[32]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[33]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[34]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[35]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[36]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[37]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[38]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[40]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[41]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[42]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[43]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[44]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[45]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[46]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[47]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[48]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[50]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[51]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[52]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[53]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[54]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[55]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[56]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[57]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[58]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[60]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[61]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[62]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[63]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[64]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[65]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[66]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[67]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[68]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[70]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[71]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[72]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[73]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[74]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[75]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[76]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[77]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[78]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[80]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[81]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[82]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[83]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[84]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[85]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[86]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[87]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[88]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[90]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[91]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[92]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[93]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[94]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[95]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[96]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[97]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[98]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[100]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[101]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[102]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[103]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[104]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[105]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[106]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[107]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[108]
Heading of this Chapter is amended according to Clause 8 Article 147 of the Decree
No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[110]
This Article is amended according to Clause 10 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[111]
This Article is amended according to Clause 11 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[112]
This Article is amended according to Clause 12 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[113]
This Article is amended according to Clause 13 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[114]
This Article is amended according to Clause 14 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[115]
This Article is amended according to Clause 15 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[116]
This Article is amended according to Clause 16 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[117]
This Article is amended according to Clause 17 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[118]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[120] The phrase “trang thiết bị y tế” (“medical device”)
is changed into "thiết bị y tế” (without change in their meaning) as
prescribed in clause 7 Article 147 of the Decree No. 96/2023/ND-CP, coming into
force from January 01, 2024.
[121]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[122]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[123]
This Clause is amended according to Clause 1 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[124]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[125]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[126]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[127]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[128]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[130]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[131]
This Article is amended according to Clause 2 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[132]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[133]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[134]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[135]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[136]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[137]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[138]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[140]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[141]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[142]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[143]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[144]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[145]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[146]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[147]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[148]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[150]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[151]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[152]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[153]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[154]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[155]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[156]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[157]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[158]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[160]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[161]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[162]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[163]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[164]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[165]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[166]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[167]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[168]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[170]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[171]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[172]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[173]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[174]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[175]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[176]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[177]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[178]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[180]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[181]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[182]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[183]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[184]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[185]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[186]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[187]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[188]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[190]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[191]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[192]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[193]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[194]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[195]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[196]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[197]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[198]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[200]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[201]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[202]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[203]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[204]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[205]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[206]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[207]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[208]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[210]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[211]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[212]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[213]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[214]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[215]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[216]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[217]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[218]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[220]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[221]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[222]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[223]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[224]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[225]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[226]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[227]
This Clause is added according to point a Clause 19 Article 147 of the Decree
No. 96/2023/ND-CP, coming into force from January 01, 2024.
[228]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[230]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[231]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[232]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[233]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[234]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[235]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[236]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[237]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[238]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[240]
This Clause is added according to point c Clause 19 Article 147 of the Decree
No. 96/2023/ND-CP, coming into force from January 01, 2024.
[241]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[242]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[243]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[244]
This Clause is added according to Point d Clause 19 Article 147 of the Decree
No. 96/2023/ND-CP, coming into force from January 01, 2024.
[245]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[246]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[247]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[248]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[250]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[251]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[252]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[253]
This Point is amended according to Clause 3 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[254]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[255]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[256]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[257]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[258]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[260]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[261]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[262]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[263]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[264]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[265]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[266]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[267]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[268]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[270]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[271]
This Article is added according to Clause 21 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[272]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[273]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[274]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[275]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[276]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[277]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[278]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[280]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[281]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[282]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[283]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[284]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[285]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[286]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[287]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[288]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[290]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[291]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[292]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[293]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[294]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[295]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[296]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[297]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[298]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[300]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[301]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[302]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[303]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[304]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[305]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[306]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[307]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[308]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[310]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[311]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[312]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[313]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[314]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[315]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[316]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[317]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[318]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[320]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[321]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[322]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[323]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[324]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[325]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[326]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[327]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[328]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[330]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[331]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[332]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[333]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[334]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[335]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[336]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[337]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[338]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[340]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[341]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[342]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[343]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[344]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[345]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[346]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[347]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[348]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[350]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[351]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[352]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[353]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[354]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[355]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[356]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[357]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[358]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[360]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[361]
This Clause is amended according to Clause 4 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[362]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[363]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[364]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[365]
Heading of this Section is amended according to Clause 5 Article 1 of the
Decree No. 07/2023/ND-CP, coming into force from March 03, 2023.
[366]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[367]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[368]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[370]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[371]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[372]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[373]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[374]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[375]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[376]
This Clause is added according to Clause 6 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from Mach 03, 2023.
[377]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[378]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[380]
This Clause is added according to Clause 7 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from Mach 03, 2023.
[381]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[382]
This Article is added according to Clause 8 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from Mach 03, 2023.
[383]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[384]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[385]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[386]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[387]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[388]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[390]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[391]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[392]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[393]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[394]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[395]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[396]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[397]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[398]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[400]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[401]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[402]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[403]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[404]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[405]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[406]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[407]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[408]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[410]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[411]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[412]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[413]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[414]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[415]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[416]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[417]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[418]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[420]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[421]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[422]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[423]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[424]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[425]
This Article is amended according to Clause 9 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[426]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[427]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[428]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[430]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[431]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[432]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[433]
This Article is amended according to Clause 10 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[434]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[435]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[436]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[437]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[438]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[440]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[441]
This Article is amended according to Clause 11 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[442]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[443]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[444]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[445]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[446]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[447]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[448]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[450]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[451]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[452]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[453]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[454]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[455]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[456]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[457]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[458]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[460]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[461]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[462]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[463]
This Point is amended according to point a Clause 12 Article 1 of the Decree
No. 07/2023/ND-CP, coming into force from March 03, 2023.
[464]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[465]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[466]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[467]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[468]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[470]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[471]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[472]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[473]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[474]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[475]
This Point is added according to Point b Clause 12 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from 03 March, 2023.
[476]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[477]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[478]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[480]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[481]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[482]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[483]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[484]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[485]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[486]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[487]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[488]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[490]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[491]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[492]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[493]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[494]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[495]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[496]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[497]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[498]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[500]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[501]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[502]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[503]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[504]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[505]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[506]
This Clause is amended according to Clause 13 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from 03 March, 2023.
[507]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[508]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[510]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[511]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[512]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[513]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[514]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[515]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[516]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[517]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[518]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[520]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[521]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[522]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[523]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[524]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[525]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[526]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[527]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[528]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[530]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[531]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[532]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[533]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[534]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[535]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[536]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[537]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[538]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[540]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[541]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[542]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[543]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[544]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[545]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[546]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[547]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[548]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[550]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[551]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[552]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[553]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
554] The phrase “trang thiết
bị y tế” (“medical device”) is changed into "thiết bị y tế” (without
change in their meaning) as prescribed in clause 7 Article 147 of the Decree
No. 96/2023/ND-CP, coming into force from January 01, 2024.
[555]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[556]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[557]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[558]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[560]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[561]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[562]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[563]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[564]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[565]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[566]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[567]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[568]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[570]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[571]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[572]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[573]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[574]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[575]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[576]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[577]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[578]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[580]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[581]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[582]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[583]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[584]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[585]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[586]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[587]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[588]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[590]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[591]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[592]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[593]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[594]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[595]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[596]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[597]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[598]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[600]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[601]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[602]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[603]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[604]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[605]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[606]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[607]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[608]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[610]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[611]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[612]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[613]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[614]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[615]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[616]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[617]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[618]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[620]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[621]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[622]
This Clause is added according to Clause 14 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from Mach 03, 2023.
[623]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[624]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[625]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[626]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[627]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[628]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[630]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[631]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[632]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[633]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[634]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[635]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[636]
This Clause is amended according to Point a Clause 15 Article 1 of the Decree
No. 07/2023/ND-CP, coming into force from March 03, 2023.
[637]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[638]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[640]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[641]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[642]
This Clause is amended according to Point b Clause 15 Article 1 of the Decree
No. 07/2023/ND-CP, coming into force from March 03, 2023.
[643]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[644]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[645]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[646]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[647]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[648]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[650]
This Clause is added according to point c Clause 15 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[651]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[652]
This Clause is added according to point c Clause 15 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[653]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[654]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[655]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[656]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[657]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[658]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article 147
of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[660]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[661]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[662]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[663]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[664]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[665]
This Clause is amended according to Clause 16 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from 03 March, 2023.
[666]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[667]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[668]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[670]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[671]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[672]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[673]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[674]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[675]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[676]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[677]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[678]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[680]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[681]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[682]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[683]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[684]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[685]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[686]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[687]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[688]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[690]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[691]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[692]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[693]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[694]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[695]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[696]
This Point is amended according to point a Clause 17 Article 1 of the Decree
No. 07/2023/ND-CP, coming into force from March 03, 2023.
[697]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[698]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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[700]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[701]
Articles 2 and 3 of the Government’s Decree No. 07/2023/ND-CP dated March 03,
2023 providing amendments to the Government’s Decree No. 98/2021/ND-CP dated
November 08, 2021 prescribing medical device management, coming into force from
March 03, 2023, stipulate that:
“Article 2. Implementation
This Decree comes into force from the date on
which it is signed.
Article 3. Responsibility for implementation
1. The Minister of Health of Vietnam shall
instruct, organize and inspect the implementation of this Decree.
2. Ministers, heads of ministerial agencies,
heads of Governmental agencies, Chairpersons of Provincial People’s Committees
and relevant authorities, organizations and individuals are responsible for the
implementation of this Decree./.”
Clause 1 and Clause 20 Article 147 and Article 148
of the Government’s Decree No. 96/2023/ND-CP dated December 30, 2023 on
elaboration of the Law on Medical Examination and Treatment, coming into force
from January 01, 2024, stipulate that:
“Article 147. Effect
...
...
...
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20. Provisions of clause 5 Article 105 of this
Decree and clause 19 of this Article shall apply from January 01, 2026.
Article 148. Responsibility for
implementation
Ministers, heads of ministerial agencies, heads
of Governmental agencies, Chairpersons of Provincial People’s Committees and
relevant authorities, organizations and individuals are responsible for the
implementation of this Decree.”
[702]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[703]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[704]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[705]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[706]
This Article is amended according to Clause 18 Article 1 of the Decree No.
07/2023/ND-CP, coming into force from March 03, 2023.
[707]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[709]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[710]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[711]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[712]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[713]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[714]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[715]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[716]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[717]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[719]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[720]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[721]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[722]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[723]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[724]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[725]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[726]
The phrase “trang thiết bị y tế” (“medical device”) is changed into "thiết
bị y tế” (without change in their meaning) as prescribed in clause 7 Article
147 of the Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.
[727] The phrase “trang thiết bị y tế”
(“medical device”) is changed into "thiết bị y tế” (without change in
their meaning) as prescribed in clause 7 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
...
...
...
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TVPL Pro Membership to see English documents.
[729]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[730]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[731]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[732]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[733]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[734]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[735]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[736]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[737]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[739]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[740]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[741]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[742]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause 7
Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January 01,
2024.
[743]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[744]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[745]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[746]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[747]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
[749]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[750]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[751]
727]; The phrase “trang thiết bị y tế” (“medical device”) is changed into
"thiết bị y tế” (without change in their meaning) as prescribed in clause
7 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[752]
The application form for approval of clinical trial made by an organization or
individual whose medical device is subject to the clinical trial included in
the application for approval of clinical trial as prescribed in Article 17 of
this Decree is amended according to point a Clause 18 Article 147 of the Decree
No. 96/2023/ND-CP, coming into force from January 01, 2024.
[753]
The application form for approval of clinical trial made by a clinical trial
institution included in the application for approval of clinical trial as
prescribed in Article 17 of this Decree is amended according to point b Clause
18 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[754]
Description of clinical trial protocol for medical device included in the
application for approval of clinical trial as prescribed in Article 17 of this
Decree is amended according to point c Clause 18 Article 147 of the Decree No.
96/2023/ND-CP, coming into force from January 01, 2024.
[755]
The application form for approval of changes in clinical trial for medical
device included in the application for approval of changes in clinical trial as
prescribed in Article 17 of this Decree is amended according to point d Clause
18 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[756]
The application form for approval of results of clinical trial for medical
device included in the application for approval of results of clinical trial as
prescribed in Article 17 of this Decree is amended according to point dd Clause
18 Article 147 of the Decree No. 96/2023/ND-CP, coming into force from January
01, 2024.
[757]
Report on results of clinical trial for medical device included in the
application for approval of results of clinical trial as prescribed in Article
17 of this Decree is amended according to point e Clause 18 Article 147 of the
Decree No. 96/2023/ND-CP, coming into force from January 01, 2024.