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THE GOVERNMENT
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: 98/2021/ND-CP
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Hanoi, November
08, 2021
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DECREE
PRESCRIBING
MEDICAL DEVICE MANAGEMENT
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;
The Government promulgates a Decree prescribing
medical device management.
Chapter I
GENERAL PROVISIONS
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1. This Decree deals with the
management of medical devices, including: classification of medical devices;
manufacture, placement on the market, trading, import, export and provision of
services related to medical devices; medical device information and
advertising; management of prices of medical devices, and management and use of
medical devices in health facilities.
2. This Decree does not apply
to:
a) Ingredients and semi-finished products used for
manufacture of medical devices, except raw materials containing narcotic
substances and precursors;
b) Raw materials for manufacture of medical devices,
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;
dd) Research Use Only (RUO) and Laboratory Use Only
(LUO) products.
Article 2. Definitions
1. “medical device” means any
instrument, implant, apparatus, material, in-vitro reagent or calibrator, or
software that meets all of the following requirements:
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- 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;
- providing information
serving diagnosis, monitoring or treatment through examination of specimens
derived from the human body.
b) The device does not achieve its principal
intended action in or on the human body by pharmacological, immunological or
metabolic means, but that may be assisted in its function by such means to serve
the purposes mentioned in Point a of this Clause.
2. “in vitro diagnostic (IVD)
medical device” 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” means a medical device 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.
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5. “product owner” means any
organization or person that:
a) supplies the medical device 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, or for assigning to it a purpose.
Article 3. Principles of
management of medical devices
1. The quality, safety and
efficacy of the medical device must be verified.
2. Adequate, accurate and
timely information about specifications and intended purpose of the medical
device and potential risks to the user must be provided.
3. The traceability of medical
devices must be ensured.
4. Medical devices 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 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.
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7. Medical devices, raw
materials or ingredients used for manufacturing of medical devices, 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;
b) Medical devices 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
Article 4. Classes of medical
devices
Medical devices shall be classified into the
following 4 classes according to their levels of potential risks related to
their designs and manufacture:
1. Class A: Low risk.
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3. Class C: Moderate-high
risk.
4. Class D: High risk.
Article 5. Classification rules
for medical devices
1. The classification of
medical devices must be carried out in accordance with risk classification
rules.
2. In the event that a medical
device 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 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.
4. In the event that a medical
device is designed to be used in combination with another medical device, each
of the medical devices shall be classified separately.
IVD medical devices 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 as a whole. IVD medical devices that are other products used in
or supporting testing process may be separately assigned into risk levels.
5. The Minister of Health
shall provide detailed guidelines on classification of medical devices in
accordance with ASEAN’s treaties on classification of medical devices to which
Vietnam is a signatory.
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Article 6. Cancellation of
classification results
1. Classification results
shall be cancelled in the following cases:
a) The incorrect classification result reduces the
level of risk of the medical device;
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 classification result from the Portal on management of medical
devices.
The decision to cancel classification result shall
be sent to the classification body, Provincial Departments of Health, General
Department of Customs and border checkpoint customs authorities, and published
on the Portal on management of medical devices.
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 that have been issued using classification
results specified in the Ministry of Health’s decision to cancel classification
results.
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1. In case a medical device 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 classification result, the
receiving authority shall refuse to issue the registration number.
2. In case a medical device
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 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.
3. In case a medical device
whose classification result is cancelled has been granted the registration
number and customs clearance but has not been purchased:
a) The registration number holder shall:
- Stop placing on the market
and recall the medical device granted the registration number using the
classification result that has been cancelled;
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- Send a report to the
registration number issuer specifying the quantity of medical device 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:
- The customs authority shall
refuse to grant customs clearance;
- The registration number
issuer shall revoke the issued registration number.
4. If the medical device has
been sold to health facilities:
a) The registration number holder shall:
- Send a report to the
registration number issuer specifying the quantity of medical device sold to
health facilities;
- Send written notices to
health facilities that purchased the medical device.
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c) If the medical device granted the registration
number using incorrect classification result is found to pose threats to
patients’ heath, health facilities shall stop using the medical device and the
registration number holder shall implement necessary measures for ensuring
normal operation of such health facilities.
Chapter III
MANUFACTURE OF MEDICAL
DEVICES
Article 8. Requirements for
quality control by medical device manufacturer
1. The manufacturer’s quality
control system must comply with ISO 13485.
2. A manufacturer of the
medical device 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:
a) It has a system for monitoring the dispatching,
warehousing, inventory and use of narcotic substances and precursors, the
medical devices and raw materials containing narcotic substances and
precursors;
b) Medical devices 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
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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
1. A set of application for
declaration of eligibility for manufacture of medical devices 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.
b) Documents in a language other than English and
Vietnamese must be translated into Vietnamese. Vietnamese translations must be
notarized in accordance with regulations of law.
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.
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Article 11. Procedures for
declaration of eligibility for manufacture of medical devices
1. Before initiating
manufacture of medical devices, the 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 factory is located
shall publish on the Portal on management of medical devices all information
about and application for declaration of eligibility for manufacture of medical
devices.
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 within 03 working days
from the occurrence of such changes.
Chapter IV
CLINICAL STUDY ON
MEDICAL DEVICES
Article 12. Clinical study
stages for medical devices
1. Stage 1: preliminary study
to determine the safety of medical device for patients and its usability for
medical practitioners and healthcare workers.
2. Stage 2: confirmatory study
to ascertain and establish evidence for the safety and efficacy of medical
device.
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Article 13. Requirements for
medical devices undergoing clinical study
1. The medical device meets
quality standards specified in the clinical study application.
2. Technical parameters of the
medical device have been duly inspected to ensure its quality and safety.
3. The medical device must be
labeled as “for clinical study only - not for any other purposes”. The labeling
of medical devices shall comply with regulations of law on labeling of goods.
Article 14. Requirements for
organizations conducting clinical study on medical devices
An organization conducting clinical study on
medical devices (hereinafter referred to as “clinical study institution”) is required
to meet the following requirements:
1. It is a scientific research
institution that is independent from the organization or individual whose
medical device undergoes clinical study.
2. It must have clinical study
laboratory or site, quality control system and technical documents that meet
the Good Clinical Practice (GCP) guidelines adopted by the Minister of Health.
3. It has adequate human
resources to conduct clinical studies, including:
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b) Researchers who must have professional
qualifications and competence meeting research requirements, and have completed
training courses in knowledge and skills in clinical study on medical devices.
Article 15. Clinical study
dossiers
A clinical study dossier consists of the following
application for approval to conduct clinical study, application for approval of
changes to clinical study, and application for approval of clinical study
results:
1. An application for approval
to conduct clinical study consists of:
a) The application form for approval to conduct
clinical study.
b) Documents about the medical device undergoing
the clinical study, including:
- Description of the
investigational product (general information about the investigational medical
device, including: name, specifications, uses and other relevant information);
- Documents about pre-clinical
study on the investigational medical device, including: study report on the
safety and efficacy of the medical device, and recommendations for use and
storage of the device;
- Documents about previous
stages of the clinical study on the medical device (in case an application for
following-stage clinical study is submitted and the medical device is not
exempt from previous clinical study stages).
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- Technical documents for
medical device;
- Technical standards and
records of testing/inspection of the medical device issued by competent authorities;
- The user manual if the
medical device undergoes stage-3 clinical study;
- Certifications of
participation given by research institutions in a multi-center clinical study
conducted in Vietnam;
- The cooperative agreement on
clinical study between the authority, organization or individual whose medical
device undergoes the clinical study and the clinical study service provider;
the cooperative agreement between organization or individual whose medical
device undergoes the clinical study and the sponsor of the clinical study (if
any).
d) Clinical study protocol and protocol
description, including: Description of the clinical study on medical device and
questionnaires or CRFs (Case Report Forms).
dd) Scientific CV and copy of certificate of
completion of GCP training course, issued by the Ministry of Health or
qualified GCP training program provider, of the principal investigator.
e) Informed consent forms given by the clinical
study volunteers.
g) The record of review of ethical and scientific
aspects of the clinical study made by the Internal Ethics Committee.
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2. An application for approval
of changes to clinical study consists of:
a) The application form for approval of changes to
clinical study.
b) Updated versions of the corresponding documents
specified in Clause 1 of this Article, as changed.
c) Review record made by the Internal Ethics
Committee if changes to the clinical study may affect the health and benefits
of the participants or the design, process and procedures of the clinical
study.
3. An application for approval
of clinical study results consists of:
a) The application form for approval of clinical
study results.
b) The copy of the approved clinical study
protocol;
c) The copy of the decision on approval of the
clinical study protocol;
d) The record of review of clinical study results
made by the Internal Ethics Committees;
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4. Requirements for documents:
a) Documents in the clinical study dossier must be
made in Vietnamese. Documents in a language other than Vietnamese must be
accompanied by their notarized Vietnamese translations.
b) Documents issued by foreign authorities require
consular legalization in accordance with regulations of law on consular
legalization, except for the case in which consular legalization is exempted in
accordance with regulations of law.
Article 16. Procedures for
approval of clinical study on medical devices
1. The clinical study
institution (the applicant) shall send, directly or by post, an application for
approval to conduct clinical study to the Ministry of Health.
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 shall transfer it to the National Ethics Committee for review.
If the application is not valid, a written notice of request for modification
of the application shall be sent to the applicant.
The applicant must complete the application within
60 days from the receipt of the notice. After this period, the application
shall be rejected.
3. Within 25 days from the
receipt of the valid application, the National Ethics Committee shall hold a
meeting to review the clinical study protocol which must be duly recorded.
If the clinical study protocol is satisfactory, the
National Ethics Committee shall issue a Certificate of approval of the clinical
study protocol.
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Within 07 working days from the receipt of the
complete application, the National Ethics Committee shall hold a meeting to
review the application. If the application is satisfactory, the National Ethics
Committee shall issue a Certificate of approval of the clinical study protocol.
If the application is refused, the National Ethics Committee shall give a
written notice in which reasons for such refusal must be specified.
An application shall not be modified more than 03
times.
4. Within 05 working days from
the receipt of the Certificate of approval of the clinical study protocol and
accompanied documents, the Ministry of Health shall issue a decision to approve
the clinical study protocol.
Article 17. Procedures for
approval of changes to clinical study on medical devices
1. The clinical study
institution (the applicant) shall send, directly or by post, an application for
approval of changes to clinical study to the Ministry of Health.
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 not valid, written notices of request
for modification of the application shall be sent to the applicant until the
application is considered valid. The applicant shall complete the application
within 60 days from the receipt of the notice. After this period, the
application shall be rejected.
If the application is valid, within 02 working
days, the Ministry of Health shall transfer the application to the National
Ethics Committee for review of changes to the clinical study protocol which
must be duly recorded.
3. Within 25 days from the
receipt of the valid application, the National Ethics Committee shall hold a
meeting to review changes to the clinical study protocol which must be duly
recorded.
If the clinical study protocol is satisfactory, the
National Ethics Committee shall issue a Certificate of approval of changes to
the clinical study protocol.
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Within 07 working days from the receipt of the
complete application, the National Ethics Committee shall review the
application. If the application is valid, the National Ethics Committee shall
issue a Certificate of approval of changes to the clinical study protocol. If
the application is refused, the National Ethics Committee shall give a written
notice, in which reasons for such refusal must be specified, to the applicant.
An application shall not be modified more than 03
times.
4. Within 05 working days from
the receipt of the Certificate of approval of changes to the clinical study
protocol and accompanied documents, the Ministry of Health shall issue a
decision to approve changes to the clinical study protocol.
Article 18. Procedures for
approval of clinical study results for medical devices
1. The clinical study
institution (the applicant) shall send, directly or by post, an application for
approval of clinical study results that is made in Vietnamese to the Ministry
of Health.
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 shall transfer it to the National Ethics Committee for
review. If the application is not valid, a written notice of request for
modification of the application shall be sent to the applicant.
The applicant shall complete the application within
60 days from the receipt of the notice. After this period, the application
shall be rejected.
3. Within 25 days from the
receipt of the valid application, the National Ethics Committee shall hold a
meeting to review clinical study results which must be duly recorded.
If the application is satisfactory, the National
Ethics Committee shall issue a certificate of approval of clinical study
results.
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Within 07 working days from the receipt of the
complete application, the National Ethics Committee shall review the
application. If the application is valid, the National Ethics Committee shall
issue a Certificate of approval of clinical study results. If the application
is refused, the National Ethics Committee shall give a written notice, in which
reasons for such refusal must be specified, to the applicant.
An application shall not be modified more than 03
times.
4. Within 05 working days from
the receipt of the Certificate of approval of clinical study results and
accompanied documents, the Ministry of Health shall issue a decision to approve
clinical study results.
Article 19. Responsibilities
of organizations or individuals whose medical devices undergo clinical study
1. Make compensation for
clinical study participants for any risks incurred from the clinical study in
accordance with regulations of law.
2. Conclude agreement on
clinical study on medical device with the clinical study institution.
3. Assume legal responsibility
for quality and safety of their medical devices.
Article 20. Responsibilities
of clinical study institutions
1. Assume responsibility for
their provided clinical study results.
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3. Ensure the integrity and
objectivity of conducted clinical studies.
4. Ensure that their economic
benefits and personnel are independent from the organization or individual
whose medical device undergoes clinical study.
Chapter V
PLACEMENT OF MEDICAL
DEVICES ON MARKET
Section 1. REGISTRATION
NUMBER, CONDITIONS FOR PLACEMENT ON THE MARKET AND REQUIREMENTS FOR
ORGANIZATIONS DECLARING APPLIED STANDARDS OR APPLYING FOR REGISTRATION NUMBER
Article 21. Registration
number of medical devices
1. Registration number of a
medical device is:
a) The number of declaration of applied standards of
Class-A or Class-B medical device;
b) The number of certificate of registration of
Class-C or Class-D medical device.
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3. Validity of registration
number: The medical device registration number shall be valid for indefinite
term, except cases where a registration number is issued according to
regulations on issuance of emergency use registration number for medical
devices 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, the Minister of Health shall decide specific
period validity of the issued registration number.
Article 22. Conditions for
placement of medical devices on the market
1. A medical device may be
placed on the market if it meets the following conditions:
a) It has been granted registration number or
import license in accordance with regulations laid down in this Decree, except
the cases specified in Clause 8 Article 3 and Article 24 of this Decree;
b) Its label contains adequate information in
accordance with regulations of law on labeling of goods;
c) Instructions for use of the medical device are
given in Vietnamese;
d) Information about warranty center, conditions
and time for warranty, except disposable medical devices defined by product
owners or cases where there are documents proving that the medical device is
not under warranty.
2. If the information
specified in Point c and Point d Clause 1 of this Article is not provided upon
the medical device 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.
Article 23. Requirements for
declaration of applied standards or issuance of certificate of registration for
medical devices
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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;
b) If the medical device 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 shall be
rejected in the following cases:
a) The medical device falls in the case specified
in Clause 1 Article 37 of this Decree;
b) The medical device is recalled under Clauses 1,
3 Article 38 of this Decree.
3. If a medical device
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 is used
for research, testing, inspection, experiment, performance evaluation,
instruction for use or device modification only.
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3. Unregistered medical
devices are imported to serve epidemic prevention and control, disaster
recovery and cannot be replaced by any other medical devices sold on the
market.
4. Medical devices 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
1. Organizations that declare
applied standards or apply for registration number for medical devices include:
a) Vietnamese enterprises, cooperatives or
household businesses that are product owners;
b) Vietnamese enterprises, cooperatives or
household businesses that are authorized by product owners;
c) Permanent representative offices in Vietnam of
foreign traders that are product owners or authorized by product owners.
2. The organization declaring
applied standards or applying for registration of a medical device must
establish and maintain a warranty center in Vietnam or sign a contract with a
qualified warranty center, except disposable medical devices as defined by
product owners 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 is the entity prescribed in
Point c Clause 1 of this Article, the product owner must establish and maintain
a warranty center in Vietnam or sign a contract with a qualified warranty
center, except disposable medical devices as defined by product owners 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
Article 26. Application for
declaration of applied standards
An application for declaration of applied standards
for Class-A or Class-B medical device consists of:
1. The declaration of applied
standards for Class-A or Class-B medical device.
2. An unexpired certificate of
conformity with ISO 13485 quality control standards.
3. The unexpired letter of
authorization given by the product owner 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, except
disposable medical devices defined by product owners 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 in Vietnamese, accompanied by technical
documents describing functions and specifications of the medical device issued
by the product owner.
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 study reports including stability report.
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With regard to domestically manufactured medical
devices, 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, 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.
7. User manual of the medical
device.
8. A sample of the label for
the medical device sold in Vietnam.
9. The unexpired CFS (for
imported medical devices).
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: original copy or certified true copy;
- For an imported medical
device: consularly legalized copy or certified true copy thereof.
c) Certificate of conformity or product standard
sheet provided by the product owner: 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: Vietnamese
copy bearing certification of the declarant, accompanied by English version
issued by the product owner, in case of imported medical devices. 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: consularly legalized copy or certified true
copy thereof.
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): original copy or certified true copy.
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1. Before placing Class-A or
Class-B medical device 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 is
headquartered shall publish the number of declaration of applied standards for
Class-A or Class-B medical device on the Portal on management of medical
devices 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, class of the medical device, 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 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 within 05 working days from the occurrence of any of the
following changes:
a) Change in address of the product owner or
registration number holder;
b) Change in name of the registration number holder
or product owner;
c) Change in the medical device 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
Article 29. Methods of
registration
1. A new registration number
shall be issued in the following cases:
a) The medical device does not have any
registration number.
b) The medical device has been granted registration
number but has any of the following changes:
- A change in the product
owner; class of the medical device; 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 or disposable medical device;
concentration, content, composition of raw materials that are active
ingredients incorporated in the medical device 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
a new registration number:
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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 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 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 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 to the organization that applies for registration, except the
case specified in Point a Clause 1 Article 25 of this Decree.
d) The certificate of eligibility to provide
warranty granted by the product owner, except disposable medical devices
defined by product owners or cases where there are documents proving that the
medical device is not under warranty.
dd) The unexpired CFS (for imported medical
devices).
e) ASEAN Common Submission Dossier Template
(hereinafter referred to as “CSDT”).
g) Certificate of conformity.
2. An application for issuance
of a new registration number for the medical device that is a measuring device
whose sample requires approval as prescribed by the law on measurement consists
of:
a) The application form for issuance of a new
registration number.
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c) The documents specified in Points b, c, d, dd
and e Clause 1 of this Article.
3. An application for quick issuance
of a new registration number for the medical device 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 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, 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 and has been granted CFS by one of EU Member
States, UK or Switzerland;
- 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 and has been granted the Marketing
Authorization by one of the reference countries;
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- 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 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.
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.
e) Certificate of inspection or certificate of
quality assessment issued by one of the inspection/assessment bodies in the
list published on the Ministry of Health’s website if the medical device falls
in one of the following cases:
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- The medical device 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.
5. An application for issuance
of a new registration number for another medical device 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 that is
reagent, calibrator or control material: certificate of quality issued by a
competent authority of Vietnam.
dd) With regard to chemicals or preparations only
used for disinfection of medical devices: Report on testing for active
ingredients for disinfection given by the entity that has declared its eligibility
to provide testing services in accordance with regulations of law on management
of insecticidal and germicidal chemicals and preparations for medical and
household use; report on trials to evaluate biological efficacy and side
effects of product on trial participants given by the entity that has declared
its eligibility to conduct trial in accordance with regulations of law on
management of insecticidal and germicidal chemicals and preparations for
medical and household use.
Article 31. Requirements for
application for issuance of a new registration number
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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 letter of authorization and
certificate of eligibility to provide warranty:
- For a domestically
manufactured medical device: original copy or certified true copy;
- For an imported medical
device: consularly legalized copy or certified true copy thereof.
c) CFS: consularly legalized copy or certified true
copy thereof.
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.
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.
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Documents issued by foreign competent authorities
must be consularly legalized. 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
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
1. The applicant shall submit
an application for registration number to the Ministry of Health through the
Portal on management of medical devices.
2. With regard to an
application for registration number for the medical device in the case
prescribed in Clause 1 or Clause 2 Article 30 of this Decree:
a) If the application is satisfactory, the Minister
of Health shall process it within 30 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.
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.
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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 05
modification times, the application shall be rejected.
3. With regard to an
application for registration number for the medical device 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 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 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 10 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 3 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.
4. With regard to an application
for registration number for the medical device in the case prescribed in Clause
4 Article 30 of this Decree:
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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 in the case
prescribed in Clause 5 Article 30 of this Decree:
a) If the application is satisfactory, the Minister
of Health shall process it within 45 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.
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.
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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 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,
including:
a) Name, category, manufacturer and manufacturing
country of the medical device;
b) Registration number of the medical device;
c) Name and address of the product owner;
d) Name and address of the registration number
holder;
dd) Name and address of the warranty center;
e) The documents included in the application for
registration of the medical device, except the documents specified in Point e
Clause 1 and Point c Clause 5 of Article 30;
g) Intended purposes of the medical device.
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a) Change in address of the product owner or
registration number holder;
b) Change in name of the registration number holder
or product owner;
c) Change in the medical device 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. Where the medical device 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.
Section 4. POST-MARKET
MANAGEMENT OF MEDICAL DEVICES AND HANDLING OF MEDICAL DEVICES IN SOME SPECIFIC
CASES
Article 33. Documents for
post-market management of medical devices
The registration number holder shall organize and
manage the tracing of origin of medical devices placed on the market and fully
retain at least the following documents to serve its management of medical
devices:
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a) The letter of authorization given by the product
owner 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, except disposable medical devices
defined by product owners 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, especially those that are defective or
unsafe for users.
4. Medical device quality
management documents, including:
a) The Certificate of Origin made in accordance
with regulations of law on origin of goods;
b) The certificate of quality of each medical
device batch issued by the product owner or manufacturer whose name is
specified in the application for registration of the medical device;
c) Record of inspection of medical device in the
case specified in Clause 1 Article 55 of this Decree;
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dd) Instructions for use of the medical device are
given in Vietnamese;
e) Information about warranty center, conditions
and time for warranty, except disposable medical devices defined by the product
owner or cases where there are documents proving that the medical device is not
under warranty.
Article 34. Handling of
medical devices 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
that poses a serious threat to public health or may cause death of users, the
registration number holder shall inform health facilities using such device 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
specified in Clause 1 of this Article is found to have a defect which may
affect the health of users, the registration number holder shall:
a) Suspend the placement of the batch of medical devices
on the market.
b) Send a written notice to the Ministry of Health,
distributors and users of such medical device. The notice shall specify the
batch number and the defect, and whether or not such defect can be repaired.
c) Establish a plan for repairing or recalling the
batch of defective medical device.
d) Send a report to the Ministry of Health after
the repair or recall of defective medical devices is completed.
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a) Within 03 working days from the receipt of the
notice from the registration number holder, the Ministry of Health shall issue
a decision to suspend the placement of the batch of defective medical devices
on the market.
A suspension decision shall contain the following
information:
- Name of the medical device
suspended from placement on the market;
- Batch number of the medical
device;
- Registration number of the
medical device.
b) After a suspension decision 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 device specified in Clause 1 Article 55 of this Decree)
or commitment to maintain quality of the medical device after the defect has
been repaired (for other medical device) to the Ministry of Health.
d) Within 20 working days from the receipt of the
report for the registration number holder, the Ministry of Health shall issue a
decision to lift the suspension. If the Ministry of Health refuses to lift the
suspension, it shall respond and explain in writing.
4. If the defect cannot be repaired:
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A recall decision shall contain the following
information:
- Name of the medical device
to be recalled;
- Batch number;
- Registration number of the
medical device.
b) The registration number holder shall recall the
entire batch of defective medical devices by the deadline imposed by a
competent authority and pay the cost of recall.
c) If the registration number holder fails to
complete the recall 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 to be
taken in case of an adverse event (AE) that has caused harm to health of users
1. In case where a medical device has an AE that pose a serious
threat to public health or has caused death of a user, the registration number
holder shall:
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;
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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, 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, submit a report to the Ministry of Health after completing the
repair or recall.
2. In case the AE 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, 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, submit a report to the Ministry of Health after completing the
repair or recall.
3. The medical device 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.
Article 36. Handling, repair
and recall of defective medical devices
1. Methods for handling
defective medical devices:
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b) Fixing the defect;
c) Replace the defective medical device with an
equivalent device;
d) Recall the defective medical device for
re-export or destruction;
2. Methods for recall of the
defective medical devices:
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 in case product owner or registration number holder no longer
carries out manufacturing or goes bankrupt or is dissolved
1. If the product owner
declares termination of manufacturing of a medical device which has been
granted the registration number or 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 product owner’s declaration of manufacturing termination,
bankruptcy or dissolution provided that the registration number holder in
Vietnam provides a commitment to provide warranty or materials for replacing or
serving the use of the medical device for 08 years, unless the registration
number holder is a permanent representative office in Vietnam of a foreign
trader that is the product owner.
2. If the registration number
holder of a medical device 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 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 for 08 years.
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4. The commitment shall
include the following documents:
a) The written commitment to provide warranty and
materials serving the use of the medical devices;
b) The list of medical devices of which it is the
registration number holder but the product owner or registration number holder
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 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. If the Ministry of Health
refuses to permit the placement of the medical device specified in Clause 1 of
this Article on the market, the registration number holder or distributor shall
recall all medical devices placed on the market, except those sold to users.
Section 5. REVOCATION OF
REGISTRATION NUMBER OF MEDICAL DEVICES
Article 38. Cases where
registration number is revoked
1. The application for
registration number is forged.
2. In case where 03 batches of
the medical device are recalled during the validity of the registration number,
except registration number holder’s voluntary recall of the medical device.
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4. The registration number
holder shuts down or is no longer authorized by the product owner and no
substitute is appointed, except the case specified in Article 37 of this
Decree.
5. Quality of the medical
device 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 as prescribed
in Clause 1 and Clause 2 Article 37 of this Decree.
8. The period for placing the
medical device on the market expires as prescribed in Clause 1 or Clause 2
Article 37 of this Decree.
9. The medical device 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.
11. The application for
declaration or issuance of registration number is found to not comply with
regulations of this Decree.
12. The medical device has
been classified against regulations on classification of medical devices.
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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 published on its website.
4. When receiving the decision
to revoke registration number of the registration number issuer, Provincial
Departments of Health shall publish the full text of the decision on their
websites and direct specialized agencies to supervise the recall of relevant
medical devices.
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.
Chapter VI
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Section 1. ELIGIBILITY
REQUIREMENTS TO BE SATISFIED BY TRADING ESTABLISHMENTS
Article 40. Requirements for
trading in Class-B, C, D medical devices
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 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 stored therein;
- be well ventilated, dry and
clean, and separated from sources of pollution;
- satisfy storage requirements
for the medical devices laid down in their user manuals.
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A trading establishment that does not have a warehouse
or vehicle may sign a contract with a qualified storage or transport service
provider.
3. Requirements for trading in medical devices that contain
narcotic substances or precursors:
a) The chief technician has a bachelor’s degree in
medical devices, medicine, pharmacy, pharmaceutical chemistry or biology.
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 containing narcotic substances and precursors.
Article 41. Application and
procedures for declaration of eligibility for medical device trading
1. An application for
declaration of eligibility for medical device trading consists of:
a) The declaration of eligibility for medical
device trading;
b) A personnel list;
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d) Documents proving that the warehouse and
inventory monitoring system for medical devices 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 that contain narcotic
substances and precursors.
2. Procedures for declaration
of eligibility for medical device trading:
a) Before trading medical devices, the trading
establishment shall submit an application for declaration of eligibility for
medical device trading to the Department of Health of province where the
trading establishment is located.
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 trading establishment is headquartered shall publish on
the Portal on management of medical devices all information about and
application for declaration of eligibility for medical device 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 within 03 working days from the occurrence of such changes.
Article 42. Trading in medical
devices without satisfying eligibility requirements and following procedures
for declaration of eligibility for medical device trading
1. Class-B, C, D medical
devices included in the list of medical devices promulgated by the Minister of
Health shall be traded as normal goods.
2. Establishments trading in the
medical devices 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.
Section 2. MANAGEMENT OF
PRICES OF MEDICAL DEVICES
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1. Manage prices of medical
devices according to the market mechanism; respect the right to pricing and
price competition of entities trading in medical devices in accordance with
regulations of law.
2. Ensure transparency of
prices of medical devices placed on the market.
3. Protect lawful rights and
interests of medical device traders and users, and of the State.
4. Take measures for ensuring
management of medical device prices appropriate for socio-economic development
in each period.
Article 44. Measures for
management of medical device prices
1. Prices of medical devices
must be declared in accordance with regulations of this Decree before they are
placed on the market in Vietnam, and declared again whenever they are changed.
2. Wholesale and retail prices
in VND of medical devices shall be posted at transaction or selling locations
of medical device trading establishments; such prices shall be publicly posted
on a board, paper or otherwise posted.
3. Successful bids for medical
devices of public health facilities must be made publicly available.
4. Trading establishments
shall not be allowed to trade medical devices before their prices are declared
or at prices higher than those available on the Ministry of Health’s Portal on
management of medical devices at the time of trading.
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1. Contents of declaration of
medical device prices:
a) Name and category of the medical device;
b) Manufacturing country;
c) Unit;
d) Import cost price of the imported medical device
or manufacturing cost of the domestically manufactured medical device;
dd) Expected profits;
e) The highest price of the medical device
determined according to its design configurations, technical functions and
unit;
g) Prices of accessories and parts (if any);
h) Warranty or maintenance costs (if any);
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k) Other costs (if any);
2. Contents about medical
device prices to be publicly posted:
a) Name and category of the medical device;
b) Manufacturer and manufacturing country; product
owner and country of product owner;
c) Unit;
d) The highest price of the medical device
determined according to its design configurations, technical functions and
unit;
dd) Prices of accessories and parts (if any);
e) Warranty or
maintenance costs (if any);
g) Training costs (if any);
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3. Prices of medical devices
shall be expressed in VND.
4. Registration number holders
shall:
a) Make declaration of prices of their medical devices
according to the declaration contents specified in Clause 1 of this Article and
publish information on the Ministry of Health’s portal before such medical
devices are placed on the market of Vietnam;
b) Update prices of medical devices whenever they
are changed;
c) Request distributors to comply with the
provisions of Points a and b of this Article in the case prescribed in Point c
Clause 1 Article 25 of this Decree. In case of multiple distributors of the
same medical device, one distributor shall be appointed to declare the medical
device price. Other distributors shall not be required to make price
declaration but shall not sell the medical device at a price higher than that
declared by the appointed distributor;
d) Make declaration and explain elements
constituting the medical device price to tax authorities or at the request of
regulatory authorities.
5. A price posted on the
Ministry of Health’s portal must include adequate information prescribed in
Clause 2 of this Article.
Section 3. EXPORT AND IMPORT
OF MEDICAL DEVICES
Article 46. Rules for
management of import and export of medical devices
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2. Medical devices that have
been granted registration numbers in Vietnam may be exported and imported without
limits on quantities and are exempt from the Ministry of Health’s approval.
3. Issuance of CFS for medical
devices shall comply with regulations of the law on foreign trade management.
4. Temporary import for
re-export, temporary export for re-import, or transit of medical devices shall
comply with regulations of law.
5. Import of used medical
devices shall comply with regulations of the law on foreign trade management.
Article 47. Export and import
of medical devices
1. Domestic enterprises are
encouraged to manufacture medical devices for export.
2. An organization or
individual that wishes to import the medical device 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, 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 storage and transport service provider;
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3. Procedures for import and
export of medical devices shall comply with regulations of the law on customs.
Importers of medical devices 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
1. An import license is required in the following cases:
a) Unregistered medical devices are imported to
serve scientific research, testing, inspection, experiment, performance
evaluation, or instruction for use or device modification only;
b) Unregistered medical devices are imported to
serve epidemic prevention and control, or disaster recovery;
c) Unregistered medical devices 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 are imported to
serve charitable medical examination and treatment;
dd) Unregistered medical devices are imported for
personal treatment of illness, including personalized medical devices, or to
serve a health facility’s special diagnosis demand;
e) Used medical
devices:
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- are temporarily imported for
re-export to serve display, product launch event, trade fair or exhibition.
Procedures for import, temporary import for
re-export of medical devices shall comply with regulations of the law on
foreign trade management.
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 in Vietnamese;
c) Certificate of conformity with quality control
standards of the manufacturer bearing the applicant’s certification;
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 device 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 device 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;
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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 device 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 device 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 device 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: 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;
n) If the medical device is imported to serve the
purposes of epidemic prevention and control or disaster recovery, the following
documents are required:
- 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 device has been granted marketing
authorization or license for emergency use by a competent authority.
3. Procedures for processing an application for license to import
medical devices:
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The import license shall be sent to the applicant
and customs authorities.
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 10 days, or 02 working days with respect to an unregistered
medical device 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
1. An application for CFS for a
medical device 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.
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
Article 51. Rights of medical
device trading establishments
1. Request the medical device
seller to provide adequate information and documents serving the tracing of
origin and warranty on the medical device.
2. Request importers, distributors
and users to cooperate in recalling and handling defective medical devices.
3. Request the registration
number holder or warranty center that is recognized by the product owner to
provide warranty on the medical device.
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5. Exercise other rights as
prescribed by laws.
Article 52. Obligations of
medical device trading establishments
1. Implement internal control
measures to maintain the quality of medical devices as prescribed by the
registration number holder.
2. Provide users with adequate
and timely information about:
a) Instructions for use of medical devices;
conditions for ensuring safety, storage, calibration, inspection and
maintenance of medical devices;
b) Notices of defective medical devices.
3. Declare and post medical
device prices in accordance with regulations of law. Do not trade medical
devices before their prices are declared or at prices higher than those
available on the Ministry of Health’s Portal on management of medical devices
at the time of trading.
4. Keep documents on
management of medical devices and carry out tracing of origin and recall of
medical devices in accordance with regulations of this Decree.
5. Promptly notify
registration number holders and state regulatory authorities of defective
medical devices.
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7. Perform other obligations
as prescribed by law.
Chapter VII
MEDICAL DEVICE-RELATED
SERVICES
Section 1. MEDICAL DEVICE
TECHNICAL CONSULTING
Article 53. Eligibility
requirements to provide medical device technical consulting
1. Consulting on listing and
formulation of technical configuration and functions of medical devices 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 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 all
information about and application for declaration of eligibility to provide
medical device technical consulting.
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Section 2. INSPECTION AND
CALIBRATION OF MEDICAL DEVICES
Article 55. Rules for
inspection and calibration of medical devices
1. Medical devices 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 that are measuring devices or
radiation equipment shall be carried out in accordance with Clause 2 of this
Article.
2. Medical devices 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 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 inspection services are the same
as those for provision of conformity assessment services.
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 into service
A medical device 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 is imported to serve scientific research or training in use, maintenance
or repair of such medical device.
3. The unregistered medical
device 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 is imported for display at a trade fair, exhibition or product launch
event.
Article 58. Handling of
unqualified medical devices
1. In case the result of the
inspection conducted before putting the medical device into service is not
satisfactory:
a) Health facilities shall not receive and use that
medical device;
b) The inspecting organization shall send a written
notice of unsatisfactory inspection result to the Ministry of Health;
c) If 03 medical devices 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 reinspection, the quantity of medical devices
that have to undergo reinspection, or suspend the use of such medical devices.
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In case 03 batches of medical devices are recalled
during the validity of the registration number, the registration number of the
medical device shall be revoked. Medical devices 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 is not satisfactory:
a) Health facilities must stop using that medical
device;
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 reinspection;
d) Only the medical device that passes the
reinspection may be used.
Chapter VIII
MANAGEMENT OF RAW
MATERIALS FOR MANUFACTURE OF MEDICAL DEVICES, SUBSTANCES FOR EXTERNAL QUALITY
ASSESSMENT THAT CONTAIN NARCOTIC SUBSTANCES AND PRECURSORS
Article 59. Rules for
management of raw materials for manufacture of medical devices, 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,
substances for external quality assessment that contain narcotic substances and
precursors
1. An application for
declaration consists of:
a) Declaration form;
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 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;
b) After receiving an adequate and valid application,
the Ministry of Health shall publish on the Portal on management of medical
devices all information and the application for declaration of raw materials
for manufacture of medical devices and substances for external quality
assessment that contain narcotic substances and precursors.
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Chapter IX
INFORMATION ON MEDICAL
DEVICES
Article 61. Information on
medical devices
1. Information on a medical device is meant to provide medical
practitioners and medical device users with instructions on how to use the
medical device reasonably and safely.
2. Information on a medical
device must be adequate, objective, accurate, truthful and easily
understandable and must not cause misunderstanding.
3. Responsibility to provide
information on medical devices:
a) Registration number holders and trading
establishments shall publish information on levels of risks and other
information related to the use of medical devices;
b) Health facilities shall internally disseminate
information on medical devices;
c) Health workers shall disseminate information on
levels of risks of Class-C, D medical devices to patients;
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4. Providers of information on
medical devices shall assume responsibility for their provided information.
5. The Minister of Health shall
organize a medical device information system.
Article 62. Advertising of
medical devices
1. Contents of an
advertisement for a medical device 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;
b) The application for registration of Class-C or
Class-D medical device.
2. An advertisement for a
medical device shall, inter alia, have the following information:
a) Name, category, product code, manufacturer and
manufacturing country of the medical device;
b) Registration number;
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d) Name and address of the registration number
holder or the entity authorized by the registration number holder;
dd) Warnings for medical device users and storage
conditions (if any).
3. Audio or video
advertisement 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 or the entity
authorized in writing by the registration number holder shall publish on the
Portal on management of medical devices planned contents and form of
advertising.
5. The registration number
holder or the entity authorized in writing by the registration number holder
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 or the application for registration
of Class-C or Class-D medical device.
6. Documents or materials that
do not contain name of a medical device, those that contain name and technical
specifications of the medical device 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 BY HEALTH FACILITIES
Article 63. Rules for
management and use of medical devices
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2. Medical devices 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 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 must be adequately prepared, managed and retained; medical devices
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.
Article 64. Management and use
of medical devices by State-owned health facilities
In addition to the provisions of Article 63 of this
Decree, State-owned health facilities shall comply with the following
provisions:
1. Investment in, purchase,
management and use of medical devices shall comply with regulations of law on
management and use of public assets.
2. Use of domestically
manufactured medical devices is encouraged.
Article 65. Rights and
responsibilities of health facilities for management and use of medical devices
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a) Request the registration number holder or the
warranty center recognized by the product owner to provide periodical maintenance
of medical device during the warranty period;
b) Request the seller to provide technical
documents of the medical device;
c) Receive the used medical devices to serve their
scientific research and training in use and repair of medical devices.
2. Each health facility shall
have the following responsibilities:
a) Use and operate the medical device according to
instructions of the product owner;
b) Carry out periodical maintenance, inspection and
calibration according to instructions of the product owner or as prescribed by
law;
c) Participate in testing for and assessment of
quality of medical devices;
d) Submit reports on defective medical devices 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.
2. Declaration of applied
standards for medical devices.
3. Application for
registration of medical device.
4. Declaration of eligibility
for medical device trading.
5. Declaration of eligibility
to provide medical device technical consulting.
6. Application for certificate
of registration of medical device inspection services.
7. Application for license to
import medical devices.
8. Application for Certificate
of Free Sale for domestically manufactured medical device.
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10. Declaration of
concentration/content of raw materials for manufacture of medical devices and
substances for external quality assessment that contain narcotic substances and
precursors.
11. Declaration of contents
and form of advertising of medical device.
Article 67. Requirements for
online application
An application for declaration, registration, and
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.
2. The online application
receiving authority shall carry out administrative procedures relevant to the
application in accordance with regulations of this Decree.
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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 manufacturer, trading establishment or consultant, raw
materials for manufacture of medical devices, substances for external quality
assessment that contain narcotic substances and precursors, medical device
inspection service provider, and registration number of the medical device;
b) Revoke the registration number and license to
import medical devices.
4. The applicant shall stop
their operation and placement of the relevant medical device on the market from
the day on which the information is removed as prescribed in Clause 3 of this
Article.
Chapter XII
ORGANIZATION OF
IMPLEMENTATION
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The Ministry of Health shall assume responsibility
before the Government for state management of medical devices 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.
2. Direct and organize the
implementation of legislative documents, national technical regulations,
strategies, policies and plans on medical devices.
3. Organize information
dissemination and communication on medical devices.
4. Provide training for human
resources in the field of medical devices.
5. Publish the following
information on the Ministry of Health’s Portal:
a) Prices of medical devices declared by
enterprises;
b) Successful bids for medical devices of
State-owned health facilities nationwide;
c) List of medical devices whose registration
number has been revoked.
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7. Carry out inspection and
settle complaints, denunciations and take actions against violations in the
field of medical devices. During inspection of medical device prices, if any
establishment is found to inadequately declare medical device prices, the competent
authority affiliated to the Ministry of Health shall request the subject
establishment to review their price information and provide explanations.
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 which must be conformable with
ASEAN’s treaties on classification of medical devices to which Vietnam is a
signatory; issue practical training programs in classification of medical devices.
10. Issue the list of medical
devices subject to inspection and class-based inspection procedures for listed
medical devices.
11. Provide guidelines for
preparation of ASEAN Common Submission Dossier Template (CSDT).
12. Provide specific provisions
on templates used during the implementation of this Decree.
Article 71. Responsibilities
of Ministry of Science and Technology
1. Issue the list of medical
devices 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; quality inspection of medical devices that are measuring
devices and radiation equipment.
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1. Provide guidelines for
management of public assets that are medical devices 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 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.
Article 73. Responsibilities
of provincial People's Committees
1. Bear responsibility to manage activities relating to trading
and use of medical devices in the province.
2. Organize information
dissemination and communication on medical devices in the province.
3. Provide training for human
resources in the field of medical devices in the province.
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 of State-owned
health facilities in the province.
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5. Carry out inspection and
settle complaints, denunciations and take actions against violations in the
field of medical devices in the province.
Article 74. Responsibilities
of medical device traders
1. Medical device traders
shall assume responsibility for safety and quality of their medical devices.
2. Domestic medical device
manufacturers shall assume responsibility to manage quality of medical devices
during manufacture, transport and storage of medical devices according to their
applications for registration number.
3. Registration number holders
shall:
a) Carry out classification of medical devices,
publish on the Ministry of Health’s Portal and assume legal responsibility for
their classification results;
Take correction measures for incorrect
classification results that reduce the level of risks of classified medical
devices or in term of authority specified in this Decree.
b) Follow procedures for declaration of applied
standards or application for registration of medical devices 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 or enter in service contracts with qualified
warranty service providers, except disposable medical devices as defined by
product owners or cases where there are documents proving that the medical
device is not under warranty;
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dd) Provide adequate and accurate information about
the product on the label and user manual of the medical devices 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;
g) Promptly stop placement on the market, take
corrective actions against or recall defective medical devices in accordance
with this Decree, and notify relevant parties. Destruction of defective medical
devices 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 as prescribed by law;
k) Ensure that the following documents are
effective during the effective period of the registration number:
- The CFS (for imported
medical devices);
- 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 defined by
product owners or cases where there are documents proving that the medical
device is not under warranty.
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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 with 01 set of quality control documents specified in Clause 4
Article 33 of this Decree;
o) Directly or designate an organization to declare
and update selling prices of medical devices;
p) Perform other obligations as prescribed by law.
4. Traders, exporters, importers and transferors of medical
devices, 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.
Chapter XIII
IMPLEMENTATION
Article 75. Effect
1. This Decree comes into
force from January 01, 2022.
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a) Government’s Decree No. 36/2016/ND-CP dated May
15, 2016;
b) Government’s Decree No. 169/2018/ND-CP dated
December 31, 2018;
c) Government’s Decree No. 03/2020/ND-CP dated
January 01, 2020.
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
1. The medical devices which
have been manufactured in Vietnam or imported into Vietnam before the effective
date of this Decree shall continue to be placed on the market until they are
liquidated in accordance with regulations of law on management and use of
public assets or the expiry date specified on the certificate of registration
or expiry date of the product.
2. Regulations on validity of
the registration number or import license issued before January 01, 2022:
a) Registration numbers of medical devices which
have been issued in accordance with the Government’s Decree No. 36/2016/ND-CP
dated May 15, 2016, as amended in Decree No. 169/2018/ND-CP and Decree No.
03/2020/ND-CP (hereinafter referred to as “Decree No. 36/2016/ND-CP”) shall be
valid for indefinite term;
b) If domestically manufactured medical devices
have been issued certificates of registration, these certificates of
registration shall be valid until the expiry dates thereon;
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d) Medical devices 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) and have been classified as Class-C or D medical devices as
published on the Ministry of Health’s Portal may continue to be imported until
December 31, 2022 without limits on quantities and confirmation as medical
devices from the Ministry of Health;
dd) Medical devices that are IVD reagents and have
been granted registration number within the period from January 01, 2014 to
December 31, 2017, these registration numbers shall be valid until December 31,
2022;
e) Medical devices that are IVD reagents and have
been granted registration number within the period on January 01, 2018 onwards,
these registration numbers shall be valid until the expiry dates thereon;
g) Import licenses issued to medical devices that
are IVD reagents on January 01, 2018 onwards shall be valid until December 31,
2022 inclusively without limits on quantities. Customs authorities shall not
control import quantities in this case.
3. Applications for registration number which are submitted in
accordance with the Decree No. 36/2016/ND-CP before January 01, 2022 but have
been not yet processed before the effective date of this Decree shall be
processed as follows:
a) With regard to an application for registration
of Class-B medical device, the Ministry of Health shall instruct the applicant
to review the application and follow procedures for declaration of applied
standards in accordance with this Decree without paying application fee.
b) With regard to an application for registration
of Class-C or D medical device, the Ministry of Health shall issue registration
number according to Article 32 of this Decree if it meets the requirements laid
down in Clause 3 Article 30 of this Decree;
c) Classification
result given by the classification body that has been granted certification of
declaration of eligibility to classify medical devices before the effective
date of this Decree may be used.
4. Applications for license to
import medical devices submitted before January 01, 2022 shall be processed in
accordance with legislative documents promulgated by the Minister of Health
before the effective date of this Decree. An import license issued according to
the provisions of this Clause shall be valid until December 31, 2022.
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6. Regulations on application
of CSDT:
a) CSDT is compulsory from January 01, 2023.
b) With regard to applications for issuance of
registration number submitted before December 31, 2022, an application shall
consist of the documents specified in Points a, b, d, dd Clause 1 Article 30 of
this Decree and the following documents:
- A synopsis of technical description
of the medical device in Vietnamese, accompanied by technical documents
describing functions and specifications of the medical device issued by the
product owner.
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 study reports including stability report.
- User manual of the medical
device.
- Sample of the label for the
medical device sold in Vietnam.
Such documents must meet the following
requirements:
- Technical documents of the
medical device: copy bearing the applicant’s certification.
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- Sample label: the sample
label bearing the applicant’s certification. The sample label must meet
requirements laid down in regulations of law on labeling of goods.
c) An application
for registration of a medical device prescribed in Point b of this
Clause shall be received and processed as follows:
- If the application is
satisfactory, the Minister of Health shall 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 an application is refused, reasons for such refusal must be given in writing.
- 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 70 days from the receipt of the application;
- 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 6 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.
7. Declaration of contents and
form of advertising of medical devices shall be applied from July 01, 2022.
8. Holders of registration
numbers or licenses to import medical devices issued before the effective date
of this Decree are required to comply with the provisions of Clause 4 Article
45 of this Decree before April 01, 2022 for their medical devices placed on the
market of Vietnam and before placing their imported medical devices on the
market of Vietnam.
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1. The Minister of Health 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.
ON BEHALF OF
THE GOVERNMENT
PP. PRIME MINISTER
DEPUTY PRIME MINISTER
Vu Duc Dam