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THE GOVERNMENT
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
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No. 36/2016/ND-CP
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Hanoi, May 15th, 2016
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DECREE
ON MEDICAL DEVICES MANAGEMENT
Pursuant to the Law on
Government organization dated December 25, 2001;
Pursuant to the Law on
Investment dated November 26, 2014;
At the request of the
Minister of Health;
The Government hereby
promulgates the Decree on medical devices management.
Chapter I
GENERAL PROVISIONS
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This Decree provides for
the management of medical devices, including the classification of medical
devices; the manufacture, registration of medical devices and provision of
services related to medical devices; information and label of medical devices
and the management and use of medical devices at medical facility.
Article 2.
Interpretation of terms
1. "Medical devices”
includes devices, tools, materials for implanting activities, reagents and in
vitro calibration solutions, software which are used separately or in
association with each other according to the instruction of the product owner
for human use for one or more of the following purposes:
a) To diagnose, prevent,
supervise, treat and eliminate the illness or to make up for pains;
b) To examine, replace,
adjust or assist surgery activities or physiology processes;
c) To support or sustain
life;
d) To control the
conception;
dd) To sterilize medical
devices, including chemicals used in testing;
e) To serve the specialized
transport or use for healthcare activities;
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2. “In vitro diagnosis medical
device” includes reagents, calibration solutions, control materials, tools,
machinery, devices and systems which are used separately or together according
to the instruction of their owners to serve the examination of samples taken
from human body.
3. “Fittings” are
products which are decided by the product owner to be used for a specific
purpose together with a specific medical device to facilitate or assist such
devices to be used for its intended use.
4. The product owner is
an organization or an individual that:
a) Provide medical
devices using its/his/her name or any label, design, trade name or other name
or code within the possession of such individual/organization;
b) Take responsibility
for the design, production, assembly, processing, labelling, packaging or the
repair of medical devices or the determination of the use of such medical
devices.
Article 3. Rules on
management of medical devices
1. Assure the quality and
safety of medical devices and assure the effective use thereof.
2. Promptly provide
sufficient and accurate information about specifications and uses of medical
devices and possible risks thereby to the users.
3. Ensure the
traceability of the origin of the medical devices.
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5. Medical devices being
measurement instruments or radiological equipment must be managed according to
laws on measuring and laws on atomic energy and the provisions of this Decree.
Chemicals and
preparations which are used only for sterilizing medical devices shall be
managed according to regulations in this Decree. Chemicals and preparations
which are used not only for sterilizing medical devices but also for other
purposes shall be managed according to laws pertaining to chemicals and/or
preparations killing insects and bacteria for domestic and medical use.
Chapter II
CLASSIFICATION OF MEDICAL DEVICES
Article 4. Classes of
medical devices
Medical devices shall be
classified into 2 groups which are divided into 4 types depending on the
possible levels of risks related to the design and production of such medical
devices:
1. Group 1 comprises
Class A medical devices which is medical devices with low level of risks.
2. Group 2 comprises
Class B, C and D medical devices, where:
a) Class B medical
devices are medical devices with lower average level of risks;
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c) Medical devices of
Class D are medical devices with high level of risks.
Article 5. Rules on
classification of medical devices
1. The classification of
medical devices must be based on the classification of levels of risks.
2. If medical devices can
be classified into multiple levels of risks, its highest level of risks shall
prevail.
3. If the medical devices
are intended to be used together with other medical devices, such devices shall
be classified separately.
4. If the medical devices
are intended to be used together with other medical devices or the medical
device has multiple uses, the classification must be based on its most
important use.
5. The Minister of Health
shall be responsible for detailing the classification of medical devices
according to international treaties on classification of medical devices by
Association of Southeast Asian Nations to which Vietnam is a signatory.
Article 6. Carrying
out classification of medical devices
1. The classification of
medical devices must be carried out by an organization satisfying the
conditions specified in Article 7 of this Decree.
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3. If there is difference
in the classification of medical devices, such classification shall be decided
by the Ministry of Health.
Article 7. Requirements
to be satisfied by classifying organizations
1. Any organization must
satisfy the following requirements to classify medical devices
a) Legally established as
prescribed by laws;
b) Having qualified
medical devices-classifying employees according to clause 2 of this Article.
2. Conditions of medical
devices-classifying employees:
a) Having at least a
bachelor’s degree in technology or medicine/pharmacy;
b) Having at least 24
months’ experience of working in the field of medical devices technologies at
hospitals, medical facilities having beds, training institutions specified in
medical devices, facilities researching medical devices, establishments
producing medical devices, classifying organizations, agencies managing medical
devices (hereinafter referred to as “medical device facilities”);
c) Having been tested and
recognized by a training institution as capable of classifying medical devices
according to the training program issued by the Ministry of Health.
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Article 8. Declaration
of eligibility for medical device classification
1. A declaration of
eligibility for medical device classification shall consist of:
a) A written document
announcing the eligibility to classify medical devices using the form No. 01
specified in Annex I enclosed with this Decree;
b) A list of employees
using the form specified in Annex II enclosed with this Decree; accompanied by
a written certificate of working time using the form in Annex III enclosed with
this Decree and qualifications of each employee conducting the classification
of medical devices.
2. Requirements for
documents in the declaration:
a) Original copies or
certified true copies of the certificates of working time;
b) Certified true copies
of qualifications of employees conducting the classification of medical
devices.
Article 9. Procedures
for declaring eligibility to classify medical devices
1. Procedures for
declaring the eligibility to classify medical devices:
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b) If the declaration is
satisfactory, the Ministry of Health shall issue the classifying organization
with the certification of declaration using the form No. 01 specified in Annex
IV enclosed herewith;
c) Within 03 working days
from the date written on the certification of declaration, the Ministry of
Health shall publish the following information on its web portal: name,
address, phone number of the classifying organization of medical devices and
the declaration of eligibility for medical device classification.
2. If there is any
modification in the declaration during its operation, the classifying
organization of medical devices shall re-conduct the procedures for declaration
of eligibility for medical device classification.
Article 10.
Recognition of classification of medical devices
1. Medical devices are
not required to be reclassified in Vietnam if it has been classified by a
competent regulatory body of a country recognized by Vietnam on the basis of
international treaties or international arrangements to which Vietnam is a
party or of a country which adopts a medical devices classification system
similar to that adopted by Vietnam.
2. The Minister of Health
shall publish the list of countries whose medical devices classifications have
been recognized by Vietnam.
Chapter III
PRODUCTION OF MEDICAL DEVICES
Article 11. Investment
incentives for the production of medical devices
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a) Any investor having a
project of producing Class B medical devices that leases state-owned land shall
be eligible for the rental rate prescribed by People’s Committees of
provinces/central-affiliated cities and shall be eligible for exemption from
land rents according to laws;
b) Any investor having a
project of producing Class C or D medical devices shall be eligible for
exemption from land rents from the day on which the project is launched;
c) Any investor having a
project of producing medical devices shall be eligible for exemption from rents
for land used for the construction of accommodations for employees or for
planting public trees.
2. Apart from investment
incentives specified in clause 1 of this Article, the project of producing
medical devices shall be eligible for other investment incentives as prescribed
by laws on investment and science and technology.
Article 12.
Requirements for employees of producers of medical devices
1. The professionals
must:
a) Have qualifications
specified in medical devices technology of college level or higher or having
qualifications specified in technique or medicine of university level or
higher;
b) Have at least 24
months experience of working in the field of technique of medical devices at a
medical devices-providing facility for at least 24 months;
c) Be a full-time worker
at the producer’s factory. The assignment and appointment of professionals
shall be made in writing.
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Article 13.
Requirements for infrastructures, equipment and quality control of producers of
medical devices
1. Having conditions of location,
area and factory in conformity with the medical devices that such producer
produces.
2. Having equipment and
procedures of production and quality inspection in conformity with the medical
devices that such producer produces. In case there is no equipment for quality
inspection, a contract with an establishment capable of conducting quality
inspection for the medical devices shall be concluded.
3. Having storage
facilities at least conformable to the following conditions:
a) Having area in
accordance with the type and the quantity of the medical devices to be stored;
b) Being airy, dry,
clean, separate from sources of pollution;
c) Satisfying other
storing requirements applicable to medical devices according to the
instruction.
4. Having vehicles for
delivering medical devices from producing establishments in accordance with the
medical devices.
5. Applying the quality
control system prescribed in clause 1 Article 68 of this Decree.
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Article 14.
Declaration of eligibility to produce medical devices
A declaration of
eligibility to produce medical devices shall consist of the following
documents:
1. A declaration of
eligibility to produce medical devices using the form No. 02 specified in Annex
I enclosed with this Decree.
2. A list of employees
using the form specified in Annex II enclosed with this Decree.
3. A document on
assignment/appointment of professionals of the producing establishment,
enclosed with the certificates of working time using the form in Annex III
enclosed with this Decree and qualifications of the professionals.
4. A certificate of
conformity with quality control standards.
In case of unavailability
of the certificate of conformity with quality control standards, documents proving
facilities satisfying requirements specified in clauses 1, 2, 3 and 4 Article
13 of this Decree are required.
In case the establishment
fails to conduct the product quality inspection itself, or in case the
establishment does not have storage facilities or transport vehicle and sign a
contract with another establishment for quality inspection, storage and
transport, documents proving that such contracting establishment is capable of
conducting quality inspection, storing and transporting medical devices
produced by the producing establishment must be enclosed.
Article 15.
Requirements for declaration of eligibility to produce medical devices
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a) Documents shall be
readable and arranged according to the order provided for in Article 14 of this
Decree; there shall be separators between different parts, there shall be cover
pages and the table of contents;
b) Documents must be made
in either English or Vietnamese.
2. Requirements for
documents in the declaration of eligibility to produce medical devices:
a) An original copy or a
certified true copy of the written assignment/appointment or qualifications of
professionals of the producing establishment;
b) The original copies or
the certified true copies of documents proving that the establishment
satisfying requirements specified in clauses 1, 2, 3 and 4 Article 13 of this
Decree;
c) An original copy or a
certified true copy or a copy certified by the applicant establishment of the
Certificate of conformity with quality control standards.
Article 16. Procedures
for making declaration of eligibility to produce medical devices
1. The establishment
shall carry out the production of medical devices only when it has obtained the
certification of declaration prescribed in point b clause 2 of this Article.
2. Procedures for making
declaration of eligibility to produce medical devices:
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b) If the declaration is
satisfactory, the Department of Health shall issue the establishment with the
certification of declaration using the form No. 02 in Annex IV enclosed with
this Decree;
c) Within 03 working days
from the date written on the certification of declaration, the Department of
Health shall publish the following information on its web portal: name of the
establishment; the professionals in charge; medical devices produced by the
establishment; contact address and phone number and the declaration of
eligibility to produce medical devices, except for the producing procedures and
the quality inspection procedures.
3. During its operation,
if there is any change related to the accepted declaration, the producing
establishment shall re-conduct the procedures for declaration of eligibility to
produce medical devices.
4. If the producing
establishment has its producing site relocated to another province, is must
notify the Department of Health where it has make the declaration of
eligibility to produce medical devices within 10 working days from the date of
relocation.
Within 03 working days
from the day on which the notification of the relocation of producing site is
received, the Department of Health receiving the declaration of eligibility to
produce medical devices shall terminate the publication of information relevant
to such establishment.
Chapter IV
REGISTRATION OF MEDICAL DEVICES
Section 1.
REQUIREMENTS FOR GRANT OF REGISTRATION, REGISTRATION NUMBER AND REQUIREMENTS
APPLIED TO ORGANIZATIONS DECLARING APPLIED STANDARDS OR APPLYING FOR
REGISTRATION
Article 17.
Requirements for registration of medical devices
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a) Having an effective
registration number or having obtained permission for import according to
provisions of this Decree;
b) Having label or
supplementary label containing sufficiently information specified in Article 54
of this Decree;
c) Having technical
documents serving the repair and maintenance of medical devices, excluding
disposable medical devices prescribed by its owner;
d) Having Vietnamese
instruction of how to use the medical devices;
dd) Having information
about warranty establishments, conditions and duration, unless the device is
disposable as decided by its owner.
2. The information
specified in points c, d and dd clause 1 of this Article which is not enclosed
with the device must be provided in form of electronic information; guidelines
for accessing to such information must be clearly stated on the label of the medical
devices.
Article 18. Conditions
for declaring applied standards of application or issuance of certificate of
free-sale registration for medical devices
1. Conditions for
declaring the applied standards or the issuing the certificate of free-sale
registration for medical devices
a) Such medical devices
shall be manufactured at the producing establishment which has declared its
eligibility to produce domestically produced medical devices;
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c) Such medical devices
shall be conformable to National technical regulation or the standard that the
producer has declared to be applied.
2. Re-application for
applied standards or registration is not available to:
a) Medical devices
specified in clause 1 Article 34 of this Decree;
b) Medical devices that
are recalled according to regulations in clauses 1 and 3 Article 35 of this
Decree.
3. The declaration of
applied standards or the application for registration of medical devices of any
of cases specified in clauses 2 and 8 Article 35 of this Decree shall not be
accepted for 12 months from the day on which the decision to revoke the
registration number is issued.
Article 19. Medical
devices exempt from declaring applied standards and free-sale registration
1. Medical devices that
is used solely for researching, testing or repairing medical devices or guiding
the use thereof.
2. Medical devices
imported into Vietnam for assisting purpose or for displaying at a fair,
exhibition or for product introduction or as a gift.
3. Medical devices
produced in Vietnam solely for export or for displaying at an overseas fair or
exhibition.
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1. Registration number of
medical devices means:
a) The number of the
certification of declaration of applied standards, applicable to Class A
medical devices, using the form No. 03 provided in Annex IV enclosed with this
Decree;
b) The number of the
certificate of registration, applicable to Class B, C or D medical devices,
using the form No. 09 provided in Annex IV enclosed with this Decree.
2. The registration
number of medical devices may be issued to one or a group of medical devices
type.
3. The registration
number holder is the organization declaring the applied standards, applicable
to Class A medical devices, or the organization obtaining the registration
number, applicable to Class B, C or D medical devices.
4. Effect of the
registration number:
a) The registration
number of Class A medical devices shall be permanently effective;
b) The registration
number of Class B, C or D medical devices shall be effective for 05 years from
the date of issue. In case where the effect of the registration number is
extended, the registration number shall be retained.
Article 21.
Requirements for organizations declaring applied standards or applying for
registration of medical devices
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a) Vietnamese
enterprises, cooperatives or business households that are in possession of
medical devices;
b) Vietnamese
enterprises, cooperatives or business households trading medical devices that
are authorized by medical devices’ owners to follow the registration
procedures;
c) Standing representative
offices in Vietnam of foreign traders who are the owners of the medical devices
or who are authorized by the owners of the medical devices.
2. Any organization
declaring the applied standards or carrying out registration of medical devices
must have warranty establishments in Vietnam or sign a contract with an
organization capable of providing warranty services on medical devices which is
registered by its name, except for disposable medical devices as prescribed by
the owners of such medical devices.
If the organization
declaring the applied standards or applying for registration of medical devices
is one of those specified in point c clause 1 of this Article, the owners of
the medical devices sign a contract with an organization capable of providing
warranty services on medical devices which is declared by its name, except for
disposable medical devices as prescribed by the owners of such medical devices.
The warranty
establishment shall be certified by the product owner to be capable of
providing warranty on products which are registered by such organization.
Section 2. PUBLICATION
OF APPLIED STANDARDS OF TYPE A MEDICAL DEVICES
Article 22.
Declaration of applied standards
The declaration of applied
standards for Class A medical devices shall consist of:
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2. A classification table
using the form in Annex V enclosed with this Decree.
3. A certification of
declaration of eligibility to produce medical devices, applicable to
domestically produced medical devices, or the Certificate of conformity with
quality control standards which is effective by the time of declaration,
applicable to imported devices.
4. The power of attorney
by the product owner for the organization declaring the applied standards using
the form in Annex VI enclosed with this Decree which is effective by the time
of declaration, except for cases specified in point a clause 1 Article 21 of
this Decree.
5. The certificate of
eligibility to provide warranty issued by the product owner using the form
provided in Annex II enclosed with this Decree, excluding disposable medical
devices prescribed by its owner.
6. Documents that give
brief description of medical devices technology using the form No. 01 in Annex
VIII enclosed with this Decree.
7. The standard which the
product owner declares to apply or the Certificate of conformity.
8. Written instruction
for the medical devices.
9. The label of the
medical devices which is intended to be used when it is sold in Vietnam.
Article 23.
Requirements for declaration of applied standards
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2. Requirements for a
number of documents in the declaration of applied standards:
a) Regarding the
certification of declaration of eligibility to produce medical devices: a copy
which is certified by the organization declaring the applied standards is
required.
b) Regarding the
Certificate of conformity with quality control standard: an original copy or a
certified true copy or a copy certified by the establishment declaring the
applied standards is required;
If the copy certified by
the organization declaring the applied standards is used, at the time of
submission of the declaration, the original copy shall be presented for
comparison or data sources shall be provided so that the receiving body checks
the validity of such documents;
Any Certificate of
conformity with quality control standard which is not made in English or
Vietnamese shall be translated into Vietnamese. The translation must be
authenticated according to laws.
c) Regarding the power of
attorney of the owner of medical devices and the Certificate of eligibility to
provide warranty:
- Regarding domestically
produced medical devices: an original copy of a certified true copy is
required;
- Regarding imported
medical devices: a consularly legalized copy or a certified true copy of the
consularly legalized copy is required.
d) Regarding the
Certificate of conformity or the standard declared by the product owner: a copy
certified by the organization declaring the applied standards is required.
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dd) Regarding the
instructions for the medical devices: a Vietnamese copy certified by the
organization declaring the applied standards is required;
e) Regarding the label
model: a copy which is certified by the organization declaring the applied
standards is required. The label model must satisfy requirements specified in
Article 54 of this Decree.
Article 24. Procedures
for declaring applied standards
1. Class A medical
devices shall only be placed on the market when the certification of
declaration of applied standards has been issued by the Department of Health as
prescribed in point b clause 2 of this Article.
2. Procedures for
declaring applied standards:
a) Before releasing Class
A medical devices, the establishment in charge of selling medical devices shall
send the declaration of applied standards specified in Article 22 of this
Decree to the Department of Health of the area where such establishment is
headquartered;
b) If the declaration is
satisfactory, the Department of Health shall issue the establishment with the
certification of declaration using the form No. 03 in Annex IV enclosed with
this Decree;
c) Within 03 working days
from the date written on the certification of declaration, the Ministry of
Health shall publish the following information on its web portal: name,
classification, producer, country of origin of medical devices; registration
number of the medical devices; name, address of the product owner; name,
address of the holder of the registration number; name, address of the
establishment providing warranty services on medical devices and the
declaration of applied standards for medical devices.
3. If the product owner
or the producer is changed, the registration number holder shall re-conduct the
procedures for declaration of the applied standards according to provisions of
this Decree.
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Article 25. Forms of
registration
1. A new registration
number shall be issued to the following medical devices:
a) Medical devices
applying for registration number for the first time;
b) Medical devices which
has been issued with the registration number and has been modified in type or
producing materials (that affects its functions, applicable to in vitro
diagnosis device and disposable medical devices);
c) Medical devices which
has been issued with registration number and its owner fails to apply for
extension of its registration number within the time specified in clause 3
Article 27 of this Decree.
2. The registration
number shall be re-issued if the Certificate of registration is lost or
damaged.
3. The time limit of the
registration number shall be extended of the registration number nearly expires
as prescribed in clause 3 Article 27 of this Decree.
Article 26.
Application for new registration number
1. An application for the
registration number of medical devices for which there is no applicable
National technical regulation:
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b) A classification table
using the form in Annex V enclosed with this Decree;
c) The certificate of
conformity with quality control standards which is effective at the time of
application, unless the medical devices has been issued with the Certificate of
Free sale (CFS) by the competent body of any of the following countries and organizations:
EU member countries, Japan, Canada, Therapeutic Goods Administration (TGA) of
Australia, Food and Drug Administration (FDA) of America;
d) The power of attorney
by the product owner for the establishment conducting the free-sale
registration using the form in Annex VI enclosed with this Decree which is
effective by the time of application, except for cases specified in point a
clause 1 Article 21 of this Decree;
dd) The certificate of
eligibility to provide warranty issued by the product owner using the form
provided in Annex II enclosed with this Decree, excluding disposable medical
devices prescribed by its owner;
e) The CFS which is
effective at the time of application, applicable to imported medical devices;
g) Vietnamese documents
that give brief description of medical devices using the form No. 01 in Annex
VIII enclosed with this Decree;
h) A catalogue describing
functions and specifications of medical devices; technical information on
reagents, calibration solutions, in vitro control materials using the form No.
02 provided in Annex VIII enclosed with this Decree;
i) Written instruction
for the medical devices;
k) Regarding Class C or D
medical devices which is used by putting into human body: the summary of
clinically testing data using the form in Annex IX enclosed with this Decree
together with the clinical trial results are required, unless:
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- Such medical devices
have permitted been placed on the market and granted the CFS by the competent
body of any of the following countries and organizations: EU member countries,
Japan, Canada, TGA of Australia, FDA of America;
- Other cases specified
by the Minister of Health.
l) Class C or D medical
devices for in vitro diagnosis must have the certificate of inspection as
prescribed by the Minister of Health, unless the medical devices has been
issued with the CFS by the competent body of any of the following countries and
organizations: EU member countries, Japan, Canada, TGA of Australia, FDA of
America;
m) The label of the
medical devices which is intended to be used when such medical devices are placed
on the market in Vietnam.
2. Regarding the application
for the registration number of medical devices with applicable National
technical regulations:
a) A written application
form for a new registration number using the form No. 04 provided in Annex I
enclosed with this Decree;
b) The certificate of
conformity;
c) Papers specified in
points b, c, d, dd, e, g, h, i and m clause 1 of this Article.
3. Regarding the
application for a new registration number of medical devices being measurement
instruments subject to obtaining the approval of the model according to laws on
measuring:
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b) The decision to
approve the model;
c) Papers specified in
points b, c, d, dd, e, g, h, i and m clause 1 of this Article.
4. Regarding the
application for a new registration number of medical devices being measurement
instruments which is not required to obtain the approval for the model as
prescribed in laws on measuring, regulations in clause 1 of this Article shall
be complied with.
Article 27.
Application for reissuance/extension of registration number
1. The application for
reissuance of the registration number which is lost or damaged shall include an
application form using the form No. 05 provided in Annex I enclosed with this
Decree.
2. An application for
extension of the registration number shall consist of:
a) A written application
form for extension of registration number using the form No. 06 provided in
Annex I enclosed with this Decree;
b) A copy of the obtained
certificate of registration;
c) The certificate of
conformity with quality control standards which is effective at the time of
application, unless the medical devices has been issued with the Certificate of
Free sale by the competent body of any of the following countries and
organizations: EU member countries, Japan, Canada, Therapeutic Goods
Administration (TGA) of Australia, Food and Drug Administration (FDA) of
America;
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dd) The CFS which is
effective at the time of application, applicable to imported medical devices;
e) The income statement
for the period when the registration number is obtained using the form in Annex
X enclosed with this Decree.
3. Time limit for
applying for extension of the registration number shall be at least 60 days
before it expires.
Article 28.
Requirements for application for new issuance/extension of registration number
1. An application for new
issuance or extension of the registration number of medical devices shall be
made in 01 dossier and documents in such dossier shall be readable and shall be
arranged according to the order specified in Article 26 of this Decree,
applicable to applications for new issuance of the registration number, or in
clause 2 Article 27 of this Decree, applicable to applications for extension of
the registration number; there shall be separators between different parts,
there shall be cover pages and the table of contents.
2. Required documents in
the application for new issuance/extension of registration number:
a) Regarding the
Certificate of conformity with quality control standards: the original copy or
a certified true copy or a copy certified by the applicant establishment is
required.
In case of including the
copy certified by the applicant establishment, the original copy shall be
presented for comparison or data sources shall be provided for checking the
validity of such documents, at the time of submission of the application.
Any Certificate of
conformity with quality control standard which is not made in English or
Vietnamese shall be translated into Vietnamese. The translation must be
authenticated according to laws.
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- Regarding medical
devices manufactured in Vietnam: an original copy of a certified true copy is
required;
- Regarding imported
medical devices: a consularly legalized copy or a certified true copy of the
consularly legalized copy is required.
c) Regarding the Certificate
of Free sale: a consularly legalized copy or a certified true copy of the
consularly legalized copy is required.
Any CFS which is not made
in English or Vietnamese shall be translated into Vietnamese. The translation
must be authenticated according to laws.
If the CFS does not
specify the date of expiry, it shall expire after 36 months counted from the
date of issue.
d) Regarding catalogue of
the medical devices: the copy certified by the applicant is required.
Any catalogue which is
not made in English or Vietnamese shall be translated into Vietnamese. The
translation must be authenticated according to laws;
dd) Regarding the
instructions for the medical devices: a Vietnamese copy certified by the
applicant establishment is required.
e) Regarding the
certificate of inspection: the original copy or a certified true copy or a copy
certified by the applicant establishment is required.
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g) Regarding the label
model: a copy which is certified by the applicant for registration of medical
devices. The label model must satisfy requirements specified in Article 54 of
this Decree.
Article 29. Receipt
and inspection of application for registration number of medical devices
1. Any establishment
applying for the registration number shall submit the application at the
Ministry of Health.
2. When receiving
satisfactory application, the Ministry of Health shall issue the applicant
establishment with the certification of declaration using the form No. 04
provided in Annex IV enclosed with this Decree.
3. In case the
application is satisfactory and not any modification is required, the Minister
of Health shall:
a) Regarding medical
devices for which there is no applicable National technical regulation: Conduct
inspection for new issuance of the registration number within 60 days or for
extension of the registration number within 30 days from the date written on
the certification of declaration. In case of refusal to issue or grant
extension of the registration number, a written response containing explanation
shall be made;
b) Regarding medical
devices with applicable National technical regulation: Conduct inspection for
new issuance of the registration number within 15 days or for extension of the
registration number within 10 days from the date written on the certification
of declaration. In case of refusal to issue or grant extension for the
registration number, a written response containing explanation shall be made;
c) The re-issuance of the
registration number shall be carried out within 05 working days from the date
written on the certification of declaration. In case of refusal to re-issue the
registration number, a written response containing explanation shall be made.
4. If the application for
the registration number is not satisfactory, the Ministry of Health shall send
a written notification to the establishment applying for new issuance,
re-issuance or extension of the registration requesting the modification,
detailing documents and information subject to modification within the periods
specified as follows:
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b) 05 working days from
the date written on the certification of declaration, applicable to
applications for re-issuance of the registration.
5. After receiving the
request for modification of the application for the registration number, the
applicant establishment shall complete the documents according to the written
notification and send them to the Ministry of Health. The date of receipt of
the completed application shall be written on the certification of declaration.
In case where the
applicant fails to comply with the request, the Ministry of Health shall
request the applicant establishment to continue completing the application
according to regulations in clause 4 of this Article.
After 60 days from the
day on which the written notification by the Ministry of Health is received, if
the applicant establishment fails to complete its application, it shall
re-conduct the procedures for applying for the registration number.
6. If the inspection
council requests the modification of the application, within 10 working days
from the day on which the meeting minute of the council is made, the Ministry
of Health shall send a written notification to the applicant establishment for
modification of the application. The notification shall specify the information
to be supplemented and the information to be adjusted.
After receiving the
request for modification of the application for the registration number, the
applicant establishment shall modify the documents according to the written
notification and re-send the application to the Ministry of Health. The date of
receipt of the completed application shall be written on the certification of
declaration.
In case where the
applicant fails to fully comply with the request, the Ministry of Health shall
request the applicant establishment to continue completing the application
according to regulations in clauses 4 and 5 of this Article.
7. Within 03 working days
from the day on which the registration number is issued, the Ministry of Health
shall publish on its web portal the following information:
a) Name, classification,
producer and country of origin of the medical devices;
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c) Name and address of
the product owner;
d) Name and address of
the registration number holder;
dd) Name and address of
the warranty provider of the medical devices;
e) The application for
registration number of the medical devices, except for information specified in
points g and h clause 1 Article 26 of this Decree.
8. During the period of
registration of medical devices, the holder of the registration number shall
send a written notification to the Ministry of Health within 10 working days
from the day on which any of the following activities is conducted:
a) The address of the
product owner or of the holder of the registration number of the medical
devices is changed;
b) Name of the
registration number holder is changed. The holder of the registration number
shall enclose with the written notification documents proving the ownership
towards the medical devices of the new owner and the label model prescribed in
Article 54 of this Decree;
c) Information about name
or address of the producer of the medical devices is modified. The registration
number holder shall enclose with the written notification of modification the
following documents: the Certificate of Free sale and the Certificate of
conformity with quality control standards which are effective at the time of
application, unless the medical devices has been issued with the Certificate of
Free sale by the competent body of any of the following countries and
organizations: EU member countries, Japan, Canada, TGA of Australia, FDA of
America;
d) The packing
specifications are changed, applicable to in vitro diagnosis medical devices.
The registration number holder shall enclose with the written notification
documents specified in points h and m clause 1 Article 26 of this Decree;
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9. Within 03 working days
from the day on which the notification by the registration number holder is
issued, the Ministry of Health shall update the modified information on its web
portal the following information.
10. The Minister of
Health shall issue regulations on the inspection of the application for
registration number.
Section 4. TRACING
ORIGIN AND HANDLING DEFECTIVE MEDICAL DEVICES, SUSPENSION OF SALE OR RECALLING
OF DEFECTIVE MEDICAL DEVICES AND HANDLING OF MEDICAL DEVICES IN SPECIFIC CASES
Article 30. Tracing
the origin of defective medical devices
1. Regarding defective
medical devices, the registration number holder shall trace the origin,
including:
a) Determining name, type
and amount of medical devices in the defective batch;
b) Publishing on the web
portal of the owner (if any) and the web portal of the Ministry of Health, and
requesting establishments producing, trading or using such medical devices in
writing to provide information on name, type and the amount of medical devices
in the defective batch, the actual amount remained in the storage and the
actual amount being on market;
c) Formulating plans on
measures to be taken or on the recall of defective medical devices;
d) Report to a competent
agency the plans specified in point c of this Clause.
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Article 31. Handling
and recalling defective medical devices
1. Measures to be taken
for defective medical devices:
a) Providing guidelines
on remedial measures;
b) Eliminating defects of
the medical devices;
c) Replacing the defective
medical devices with the equivalent one;
d) Recalling for
re-exporting or destruction.
2. Defective medical
devices shall be recalled as follows:
a) Voluntary recalling
conducted by the registration number holder;
b) Compulsory recalling,
for cases specified in Article 35 of this Decree.
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If the registration
number holder fails to recall the defective medical devices within the time
limit specified by the competent agency, the recall shall be enforced as
prescribed legislation on penalties for administrative violations.
Article 32. Procedures
for suspension of sale of defective medical devices against which a warning has
been issued by owner of medical devices
1. If the medical devices
are found to be defective and have bad effect on users’ health, the
registration number holder shall:
a) Suspend such medical
devices from sale;
b) Send a written
notification to the Ministry of Health and organizations and persons that are
selling or using such medical devices. The notification shall specify the
manufacture batch, the factor causing bad effect on users’ health and the
statement whether such factor can be eliminated.
2. In case the defect of
the medical devices that causes bad effect on users’ health can be eliminated:
a) Within 03 working days
from the day on which the notification by the product owner is received, the
Ministry of Health shall issue a decision to suspend the sale of such medical
devices;
b) When the decision to
suspend the sale of the medical devices has been issued, the registration
number holder in Vietnam shall take measures to eliminate the factor that
causes bad effect on users’ health;
c) After completing the
elimination of the factor that causes bad effect on users’ health, the
registration number holder shall send a written report to the Ministry of
Health which contains the undertaking to assure the quality of the medical
devices after the elimination or the inspection result by a laboratory which is
conformable to the TCVN ISO/IEC 17025 national standard or the ISO/IEC 17025
international standard or a equivalent standard;
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3. If the defect of the
medical devices that causes bad effect on users’ health cannot be eliminated,
the Ministry of Health shall issue a decision to recall all the devices of the
batch of medical devices which incurs the suspension.
4. The decision to
suspend the sale shall consist of:
a) Name of medical
devices to incur the suspension;
b) The number of the
batch of medical devices to incur the suspension;
c) The registration
number of the medical devices to incur the suspension;
Article 33. Procedures
for suspension of sale of defective medical devices against which a warning has
been issued by a competent
1. Within 05 working days
as from the day on which the notification of the defect that causes bad effect
on users’ health made by a medical facility of another country where the
medical devices are being sold or to which they are sent by World Health
Organization, the Ministry of Health shall send a written request to the
registration number holder for explanatory report.
2. Within 05 working days
from the day on which the written response by the Ministry of Health is
received, the registration number holder shall send a written report to the
Ministry of Health.
3. Within 5 working days
from the day on which the report made by the registration number holder of
medical devices in Vietnam is received, the Ministry of Health shall establish
a scientific council for assessing the defect that causes bad effect on users'
health.
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5. If it is determined
that the medical devices have defect causing bad effect on users’ health, the
Ministry of Health shall follow the procedures for suspension of such devices
from sale according to regulations in clauses 2, 3 and 4 Article 32 of this
Decree.
Article 34. Handling
of medical devices whose owner or whose registration number’s holder terminates
the production or is bankrupt or dissolved
1. If the medical devices
has been issued with the registration number but the owner of such medical
devices declares terminating the production or declares bankruptcy or
dissolution, such medical devices shall be on market for not exceeding 24 more
months counted from the date of such declaration, provided that the holder of
the registration number in Vietnam shall undertake to provide the warranty and
maintenance as well as provide materials for replacing or serving the use of
medical devices for 08 years, unless the holder of the registration number is
the standing representative office in Vietnam of the foreign trader who is the
owner of such medical devices.
2. If the medical devices
has been issued with the registration number but the registration number holder
is bankrupt or dissolved, such medical devices shall be on market for not
exceeding 24 months counted from the date of such bankruptcy/dissolution,
provided that the distributing establishment shall undertake to provide the
warranty and maintenance as well as provide materials for replacing or serving
the use of medical devices for not more than 08 years.
3. The holder of the
registration number or the distributing establishment shall send the dossier
about its undertaking to the Ministry of Health within 60 days from the day on
which the product owner or the holder of the registration number declares
terminating the manufacture or declares bankruptcy or dissolution.
4. The undertaking
dossier shall consist of:
a) A written undertaking
to provide the warranty and maintenance and provide materials serving the use
of medical devices using the form provided in Annex XI enclosed with this
Decree;
b) A list of medical
devices having registration number kept by such establishment whose owner or whose
registration number’s owner of the medical devices declared terminating the
manufacture or declared bankruptcy or dissolution.
5. Within 15 working days
from the day on which the undertaking prescribed in clause 4 of this Article,
the Ministry of Health shall make a written response on the approval or refusal
of the maintenance of registration of medical devices. In case of refusal,
explanation shall be provided.
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Section 5. REVOCATION
OF REGISTRATION NUMBER OF MEDICAL DEVICES
Article 35. Cases
where registration number is revoked
1. The applicant uses
fraudulent documents to apply for registration.
2. The registration of 03
batches of the medical devices is revoked within the effective period of the
registration number, applicable to types B, C or D medical devices, or for 05
years, applicable to Class A medical devices, unless the registration number
holder voluntarily recalls the medical devices as prescribed in Article 32 of
this Decree.
3. The applicant
falsifies the contents of the registration number without permission.
4. The registration
number holder terminates its operation or is no longer authorized by the
product owner and no substitute organization has been appointed, except for
cases specified in Article 34 of this Decree.
5. Quality of medical
devices being sold on market is not consistent with the registration quality.
6. The registration
number has been issued against provisions of this Decree.
7. The owner of the
registration number or the distributing establishment of the medical devices
has not given undertakings as prescribed in clauses 1 and 2 Article 34 of this
Decree.
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9. The medical devices
were manufactured at an establishment unconformable to requirements specified
in this Decree.
Article 36. Procedures
for revocation of registration number
1. During the inspection,
if any case specified in clauses 1, 2, 3, 4, 5, 6 and 8 Article 35 of this
Decree is discovered, the agency conducting the inspection shall send an
inspection record to the Ministry of Health or the Department of Health having
issued the registration number (hereinafter referred to as “registration number
issuer”).
2. Within 05 working days
from the day on which the record specified in clause 1 of this Article is
issued, the registration number issuer shall consider deciding the revocation
of the registration number within its management.
3. After issuing the
decision to revoke the registration number, the agency issuing the decision on
revocation shall:
a) Publish on the web
portal of the registration number issuer the decision on revocation of
registration number and send such decision to the registration number holder,
the Ministry of Health and other Departments of Health nationwide;
b) Annul information
related to medical devices which has been posted on the web portal of the
registration number issuer.
4. When the decision to
revoke the registration number made by the registration number issuer has been
received, Departments of Health shall publish it on the web portal and direct
professional bodies to supervise the revocation of the medical devices.
Chapter V
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Section 1. CONDITIONS
FOR TRADING MEDICAL DEVICES
Article 37. Class B, C
or D medical devices trading establishments
As establishment must
satisfy the following conditions to trade in Class B, C or D medical devices:
1. Having technical staff
with acceptable qualifications for installing or guiding the use of medical
devices which such establishment trades, at least 01 of whom has the
qualifications of technology or medicine/pharmacy of college or higher level or
has the qualifications of medical devices technology of college or higher level
and his/her profession is conformable to the medical devices which the
establishment trades.
2. Having storage
facilities conformable to the requirements specified in clause 3 Article 13 of
this Decree and having vehicles for delivering medical devices conformable to
requirements specified in clause 4 Article 13 of this Decree, unless otherwise
prescribed by laws. If the establishment does not have storage facilities or
vehicles, a contract with an establishment capable of storing and transporting
medical devices shall be concluded.
Article 38. Procedures
for declaration of eligibility to trade medical devices
1. The declaration of
eligibility to trade medical devices shall consist of:
a) A declaration form of
eligibility to trade medical devices using the form No. 07 specified in Annex I
enclosed with this Decree;
b) A list of employees
using the form specified in Annex II enclosed with this Decree;
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2. Procedures for
declaration of eligibility to trade medical devices:
a) Before trading Class
B, C or D medical devices, heads of medical devices trading establishments
shall send an declaration of eligibility to trade medical devices specified in
clause 1 of this Article to the Department of Health of the area where the
trading establishment’s headquarters are located;
b) If the declaration is
satisfactory, the Department of Health shall issue the establishment with the
certification of declaration using the form No. 05 in Annex IV enclosed with
this Decree;
c) Within 03 working days
from the day on which the declaration of eligibility to trade medical devices,
the Department of Health shall publish the following information on its web
portal: name and address of the establishment trading medical devices and the
declaration of eligibility to trade medical devices.
3. The establishment
shall be allowed to trade Class B, C or D medical devices only when the
procedures specified in point b clause 2 of this Article are fully conducted,
except for cases specified in Article 39 of this Decree.
4. During its operation,
if there is any change in employee staff, storage system or transport vehicles,
the trading establishment shall re-conduct the procedures for declaration of
eligibility to trade medical devices.
Article 39. Trade of
Class B, C or D medical devices which is not required to satisfy conditions nor
follow procedures for declaring eligibility to trade medical devices
1. Class B, C or D
medical devices in the list of medical devices issued by the Minister of Health
shall be traded like other normal goods.
2. The trade of medical
devices specified in clause 1 of this Article is not required to satisfy
conditions specified in Article 37 of this Decree and is not required to follow
the procedures for declaring the eligibility to trade prescribed in Article 38
of this Decree, provided that such trading is conformable to the requirements
for storage and transport prescribed by the product owner.
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Article 40. Rules on
management of export/import of medical devices
1. Any organization or
individual exporting or importing medical devices must satisfy conditions
specified in laws on export and import and must assure the quality of the
medical devices that they exported/imported.
2. Medical devices having
got the registration number in Vietnam may be exported/imported on demand
without limit on quantity and without approval by the Ministry of Health.
3. The CFS shall only be
issued to medical device for exports as prescribed by the Prime Minister.
4. The temporary import,
temporary export or transit of medical devices shall be carried out according
to laws.
5. The import of used
medical devices shall be carried out according to laws.
Article 41. Export and
import of medical devices
1. The production of
medical devices for export is encouraged.
2. Any
organization/individual importing medical devices with the registration number
must satisfy the following conditions:
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b) Having storage facilities
conformable to the requirements specified in clause 3 Article 13 of this Decree
and having vehicles for delivering medical devices conformable to requirements
specified in clause 4 Article 13 of this Decree or having the contract with the
establishment capable of storing and transporting medical devices.
3. The export and import
of medical devices shall comply with laws on customs. When conducting customs
procedures, the organization importing medical devices is not required to prove
the conformity with conditions specified in Clause 2 of this Article.
Article 42. Import
license
1. Cases in which a
license to import medical devices is required:
a) Such medical devices
does not have the registration number and is imported for scientific research or
testing or for guiding the use of medical devices or for repairing medical
devices;
b) Such medical devices
do not have the registration number and is imported to be used as aids;
c) Such medical devices
do not have the registration number and is imported for personal healthcare.
2. An application for the
import license shall consist of:
a) A written application
form for an import license using the form No. 08 provided in Annex I enclosed
with this Decree;
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c) The Certificate of
conformity with quality control standards of the establishment producing the
medical devices applying for the import license;
d) For medical devices
imported for research, a certified true copy of the decision on approval for
the research project and documents proving that such products have been
permitted in the exporting country by the competent agency;
dd) Regarding medical
devices imported to be use in training, the original copy of the training plan
and documents proving that such products have been permitted in the exporting
country by the competent agency;
e) For medical devices
imported to be used as aids, a copy of the decision on approval for aid receipt
by the competent authority and documents proving that such products have been
permitted in the exporting country by the competent agency ;
g) For cases where
medical devices are imported for personal healthcare, the prescription by the
doctor.
3. Procedures for
processing the application for the license for importing medical devices:
a) After receiving the
application, the Ministry of Health shall issue the applicant with the
certification of declaration using the form No. 06 provided in Annex IV
enclosed with this Decree;
b) If the application is
not required to be amended, the Ministry of Health shall conduct inspection
serving the issuance of the license for importing medical devices within 15
working days from the date written on the certification of declaration. If the
application is rejected, a written response containing explanation shall be
made;
c) If the application is
unsatisfactory, within 05 working days from the date written on the
certification of declaration, the Ministry of Health shall send a written
response to the applicant for completion. The notification shall specify the
information to be supplemented and the information to be adjusted;
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If the applicant fails to
fully comply with the request, the Ministry of Health shall notify the
applicant for completing it;
After 60 days from the
day on which the request of the Ministry of Health is received, if the
applicant fails to complete the application, the procedures for applying for
the import license shall be re-conducted.
dd) If the application is
satisfactory, the Ministry of Health shall issue the license for importing
medical devices according to regulations in point b of this clause. The import
license shall be sent to the applicant and the customs authority.
Article 43.
Application for CFS of domestically produced medical devices
1. An application for the
Certificate of free sale of medical devices without the registration number
shall include:
a) A written application
form for the Certificate of free sale using the form No. 11 provided in Annex I
enclosed with this Decree;
b) Documents specified in
Article 22 (applicable to Class A medical devices) or Article 26 (applicable to
Class B, C or D medical devices).
2. The application for
the certificate of free sale of medical devices must satisfy requirements
specified in Article 23 (applicable to Class A medical devices) or Article 28
(applicable to Class B, C or D medical devices).
3. The application for
the Certificate of Free sale of medical devices with the registration number
shall include the application form using the form No. 12 provided in Annex I
enclosed with this Decree.
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1. The Minister of Health
shall be responsible for the issuance, reissuance and revocation of the
Certificate of free sale of medical devices.
2. Procedures for
issuance, reissuance and revocation of the Certificate of free sale shall
comply with regulations of the Prime Minister on the issuance of the
Certificate of Free sale.
Section 3. RIGHTS AND
OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS TRADING MEDICAL DEVICES
Article 45. Rights of
establishments trading medical devices
1. To request the medical
devices seller provides sufficiently information and documents to be used for
tracing the origin and the warranty of medical devices.
2. To request
organizations/individuals importing, distributing or using products to
cooperate with them in recalling and handling defective medical devices.
3. To request the holder
of the registration number of the medical devices to provide warranty on the
medical devices.
4. To be notified by the
holder of the registration number of the defective medical devices.
5. Other rights as
prescribed in laws.
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1. Conduct internal
supervision to maintain the quality of medical devices prescribed by the holder
of the registration number.
2. Provide sufficiently
and promptly information about:
a) Instruction on how to
use the medical devices; conditions for ensuring the safety, storing,
calibrating, inspecting and maintaining medical devices;
b) Give notification of
defective medical devices.
3. Retain medical devices
supervision dossier and trace the origin or recall medical devices according to
regulations in this Decree.
4. Promptly notify the
registration number holder and the authority of the defective medical devices.
5. Comply with laws and
decisions on inspection issued by competent agencies.
6. Other obligations as
prescribed in laws.
Chapter VI
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Section 1. CONSULTANCY
ABOUT MEDICAL DEVICES TECHNOLOGY
Article 47. Conditions
for providing consultancy services on medical devices technology
1. The provision of
services for consulting about the listing and formulation of technical
structure and specifications of medical devices technology shall be conducted
by an individual who has been issued with the certificate of completing the
training in consulting medical devices technology.
2. Requirements
applicable to individuals providing consultancy services on medical devices
technology:
a) Having university
level qualifications specified in technique or medicine/pharmacy;
b) Having at least 5
years’ experience of working in the field of medical devices technology at a
medical devices-providing facility;
c) Having been tested and
recognized by training institutions to be capable of consulting on medical
devices technology according to the training program issued by the Ministry of
Health.
3. The consultant shall
provide only consultancy on medical devices technology when he/she has obtained
the certification of declaration for the application for declaration of
eligibility to provide consultancy about medical devices technology as
prescribed in point b clause 2 Article 48 of this Decree.
Article 48. Procedures
for declaration of eligibility to provide consultancy on medical devices
technology
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a) An application form
for declaration of eligibility to provide consultancy using the form No. 09
specified in Annex I enclosed with this Decree;
b) Certified true copies
of qualifications specified in points a and c clause 2 Article 47 of this
Decree;
c) A certificate of
working time using the form in Annex II enclosed with this Decree.
2. Procedures for
declaration of eligibility to provide consultancy on medical devices
technology:
a) Before providing
consultancy on medical devices technology, the applicant shall send the documents
specified in clause 1 of this Article to the Ministry of Health;
b) If the application is
satisfactory, the Ministry of Health shall issue the certification of
declaration using the form No. 07 provided in Annex IV enclosed with this
Decree;
c) Within 03 working days
from the date written on the certification of declaration, the Ministry of
Health shall publish the following information on its web portal: name,
address, phone number of the consultant; scope of consultancy on medical
devices technology and the declaration of eligibility to provide consultancy on
medical devices technology.
3. During its operation,
if there is any change related to the accepted declaration, the consultant
shall re-conduct the procedures for declaration of eligibility to provide
consultancy on medical devices technology.
Section 2. INSPECTION
AND CALIBRATION OF MEDICAL DEVICES
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1. Medical devices shall
be inspected according to laws on product quality and shall be calibrated
according to regulations by the manufacturer, except for cases specified in
clause 2 of this Article.
2. The inspection and
calibration of medical devices being measurement instruments or radiological
equipment shall comply with regulations on measuring and atomic energy.
3. The inspection of
medical devices shall be conducted by establishments which have declared the
eligibility to provide services on inspection and calibration for medical
devices.
4. The calibration of
medical devices shall be conducted by an establishment which has declared the
eligibility to provide services on inspection and calibration for medical
devices or by the warranty provider of the holder of the registration number of
the medical devices.
Article 50.
Requirements for establishments conducting inspection and calibration of
medical devices
1. Employees:
There shall be at least 2
technical employees (civil servants or employees working under contracts which
are valid for 12 months or more or employees working under indefinite
contracts) who satisfy the following conditions:
a) Having qualifications
of college or higher level specified in technique or medicine/pharmacy;
b) Having professions
suitable for the medical devices he/she is assigned to inspected/calibrated.
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There shall be
laboratories. The laboratory shall obtain the certificate of conformity with
the national standard on competence of testing and calibration laboratories
TCVN ISO/IEC 17025 or the international standard ISO/IEC 17025 (hereinafter
referred to as the certificate of conformity with testing and calibration
standards).
3. The establishment
shall carry out the inspection/calibration of medical devices only when it has
obtained the certification of declaration of eligibility to conduct the
inspection/calibration of medical devices as prescribed in clause 2 of this
Decree.
Article 51.
Declaration of eligibility to conduct inspection/calibration
1. A declaration of
eligibility to conduct the inspection/calibration shall consist of:
a) An application form
for declaration using the form No. 10 specified in Annex I enclosed with this
Decree;
b) A list of employees
using the form specified in Annex II enclosed with this Decree;
c) The certificate of
conformity with testing and calibration standards which is valid at the time of
declaration.
2. Requirements for the
declaration of eligibility to conduct the inspection/calibration:
a) Documents serving the
declaration of eligibility to conduct the inspection/calibration shall be compiled
into 01 dossier, readable and arranged in order specified in clause 1 of this
Article; there shall be separators between different parts, there shall be
cover pages and the table of contents;
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If the copy certified by
the organization declaring the eligibility to conduct the inspection/calibration
is used, at the time of submission of the declaration, the original copy shall
be presented for comparison or data sources shall be provided so that the
receiving body can check the validity of such documents.
Any Certificate of
conformity with inspection/calibration standards which is not made in English
or Vietnamese shall be translated into Vietnamese. The translation must be
authenticated according to laws.
Article 52. Procedures
for declaring the eligibility to conduct the inspection/calibration
1. Before conducting the
inspection/calibration of medical devices, heads of the inspection/calibration
establishment shall send the application specified in clause 1 Article 51 of
this Decree to the Ministry of Health.
2. If the declaration is
satisfactory, the Ministry of Health shall issue the establishment with the
certification of declaration using the form No. 08 in Annex IV enclosed with
this Decree.
3. Within 03 working days
from the date written on the slip of receiving, the Ministry of Health shall publish
the following information on its web portal: name, address, phone number of the
establishment conducting the inspection/calibration of medical devices; scope
of the inspection/calibration and the declaration of eligibility to conduct the
inspection/calibration.
4. During its operation,
if there is any change related to the accepted declaration, the
inspection/calibration establishment shall re-conduct the procedures for
declaring the eligibility to conduct the inspection/calibration of medical
devices.
Chapter VII
INFORMATION AND LABEL OF MEDICAL DEVICES
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1. Information about
medical devices is meant to serve healthcare practitioners and users with
guidelines on the reasonable and safe use of medical devices.
2. Information about
medical devices must be sufficient, objective, accurate, honest, understandable
and must not cause misunderstanding.
3. Responsibility for
communicating information about medical devices:
a) The registration number
holder and the trading establishment of the medical devices shall publish the
information about the level of risks and information related to the use of
medical devices;
b) Medical facility shall
communicate information about medical devices within their establishment;
c) Health workers shall
communicate information about the level of risks of the use of Class C or D
medical devices on the patients;
d) Medical devices
management agencies shall publish the information on medical devices.
4. Any organization and
individual communicating information about medical devices must be responsible
for the information it/he/she has provided.
5. The Minister of Health
shall develop medical devices information system.
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1. The labeling of
medical devices shall comply with regulations in Decree No. 89/2006/ND-CP dated
August 30, 2006 by the Government on labeling of goods and the label must
contain:
a) Name of the medical
devices;
b) The registration
number of the medical devices;
c) Name and address of
the holder of the registration number of the medical devices;
d) The origin of the
medical devices;
dd) Date of production or
expiry date. The date of production and the expiry date must be written in the
format [dd/mm/yyyy] or [mm/yyyy].
e) Number of batch or the
serial number of the medical devices;
g) Guidance for seeking
information about the warranty provider, guidelines for using the medical
devices, technical documents serving the repair and maintenance according to
regulations in clause 2 Article 17 of this Decree.
2. Medical devices
imported into Vietnam whose label does not contain sufficiently the information
specified in clause 1 of this Article must be enclosed with a supplementary
label containing such information written in Vietnamese and the original label
of the devices shall be retained.
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MANAGEMENT AND USE OF MEDICAL DEVICES AT
MEDICAL FACILITIES
Article 55. Rules on
management and use of medical devices
1. The management and use
of medical devices must be conformable with the purposes, utilities, policies
and economical and effective.
2. The inspection,
maintenance, repair, verification and calibration must comply with regulations
of the producer, unless otherwise prescribed by laws.
Regarding medical devices
with strict labour hygiene and safety requirements, apart from the regulations
on inspection, maintenance, repair, verification and calibration specified in
this Decree, laws on labour hygiene and safety shall be complied with as well.
3. Documents on medical
devices shall be compiled, managed and retained sufficiently; the settlement of
medical devices in kind or in cash shall be conducted according to current laws
on accounting and statistics and other relevant law provisions; funding for the
conduct of tasks specified in Clause 2 of this Article shall be secured.
4. Medical facilities
shall submit to the inspection and supervision of competent regulatory bodies
specified in medical devices management.
Article 56. Management
and use of medical devices at State medical facilities
Apart from complying with
regulations in Article 55 of this Decree regarding the management and use of
medical devices, state medical facilities shall conform to the following
regulations:
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2. Policies on management
and use of medical devices shall be published.
3. The investment in or
the conduct of the purchase of medical devices shall conform to the following
rules:
a) The investment as well
as the purchase of medical devices shall be conformable to the functions, tasks
and demand of the unit and current laws on bidding;
b) State medical
facilities are encouraged to use domestically produced medical devices.
Regarding domestically produced medical devices which are declared by the
Ministry of Health to be conformable to the requirements on quality and supply,
the bidding documents and the invitations for bid shall contain provisions that
forbid the bidders from offering imported medical devices.
Article 57. Powers and
responsibilities of medical facilities in the management and use of medical
devices
1. A medical facility
shall have the following powers:
a) To request the
registration number holder to carry out the periodic maintenance during the
warranty period;
b) To request the seller
to supply technical documents about medical devices;
c) To receive medical devices
that is used for scientific research or for guiding the use of medical devices.
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a) Use and operate
medical devices according to the guidance by its owner;
b) Periodically maintain,
inspect and calibrate medical devices according to the guidance by its owner or
according to laws;
c) Conduct testing and
assessment of quality of medical devices;
d) Report cases of
defective medical devices and other information at the request of competent
agencies.
Chapter IX
ONLINE DECLARATION AND REGISTRATION
Article 58. Cases
subject to online declaration, registration or licensing
1. Declaration of
eligibility for medical device classification.
2. Declaration of
eligibility to produce medical devices.
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4. Registration of
medical devices.
5. Declaration of
eligibility to trade medical devices.
6. Declaration of
eligibility to provide consultancy on medical devices technology.
7. Declaration of eligibility
to conduct the inspection/calibration of medical devices.
8. Application for the
license to import medical devices.
9. Application for the
CFS for domestically-produced medical devices.
Article 59. Online
application for declaration, registration or licensing
A valid online
declaration, online application for registration or the license or the CFS
(hereinafter referred to as the online registration application) shall satisfy
the following requirements:
1. It contains sufficient
documents according to regulations applicable to written application which are
transformed into electronic documents. Such electronic documents shall be named
according to the name of the form in the written application.
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Article 60. Procedures
for online declaration
1. The legal
representative shall make declaration, download electronic documents, confirm
with public digital signatures and pay charges according to the procedures
specified on the web portal of the Ministry of Health or the Department of
Health.
2. When the online
application has been submitted, the representatives at law shall receive a
receipt note.
3. The online application
receiving body shall carry out administrative procedures for the application
according to regulations in this Decree.
4. The result of the
online administrative procedures is an electronic document with the digital
signature of the receiving body and shall have legal effect like the one of the
normal administrative procedures.
Article 61. Retention
of online applications
1. In case of online
application, the applicant shall retain the written documents of the
application.
2. If any document of the
registration dossier specified in clause 1 of this Article is lost or damaged,
the registering establishment shall send a written notification to the
receiving body, recomplete the dossier; when the application has been
recompleted, the applicant shall notify the receiving body in writing and
update the information after being approved by the receiving body.
3. Within 35 days from
the day on which the notification of the loss of the application is received,
if the applicant fails to issue a written notification of the recompletion of
the application, the receiving body shall:
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b) Revoke the
registration number and the import license of the medical devices.
4. The registering
establishment shall not continue its operation and the medical devices shall
not be placed on the market from the time the receiving body annuls the
information as prescribed in clause 3 of this Article.
Chapter X
ORGANIZATION OF IMPLEMENTATION
Article 62. The
Ministry of Health
The Ministry of Health
shall be answerable to the Government for the management of medical devices and
shall have the following tasks and powers:
1. Request the Government
or the Prime Minister to promulgate or promulgate by itself within their
competence legislative documents, National technical regulation, strategies,
policies and plans regarding medical devices.
2. Direct and conduct the
implementation of legislative documents, strategies, policies and plans
regarding medical devices.
3. Conduct the
communication of information about medical devices.
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5. Publish on the web
portal of the Ministry of Health information about:
a) The winning price of
the bidding for medical devices of medical facilities nationwide;
b) The list of medical
devices whose registration number has been revoked.
6. Conduct inspection,
resolve complaints/denunciations and impose penalties for violations against
laws pertaining to medical devices.
7. Promote the
international cooperation in medical devices.
Article 63. The
Ministry of Science and Technology
1. Issue the list of
medical devices and measurement instruments subject to obtaining model
approval, inspection and/or calibration after receiving the opinion of the
Ministry of Health.
2. Preside over or
cooperate with the Ministry of Health in formulating national standards on
medical devices; conduct inspection of the quality of medical devices being
measurement instruments or radiological equipment.
Article 64. The
Ministry of Finance
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2. Provide detailed
regulations on the management and use of charges and fees pertaining to medical
devices according to laws on charges and fees.
Article 65. People’s
Committees of provinces and central-affiliated cities
1. Manage activities
related to the trade and use of medical devices in local areas.
2. Conduct the
communication of information about medical devices in local areas.
3. Provide training for
human resources whose work involves medical devices in local areas.
4. Publish on the web
portals of People’s Committees of provinces or central-affiliated cities and
send the Ministry of Health information about:
a) The winning prices of
the bidding for medical devices of medical facilities in local areas;
b) The list of medical
devices whose registration number has been revoked within local areas.
5. Conduct inspection,
resolve complaints/denunciations and impose penalties for violations against
laws pertaining to medical devices in local areas.
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1. Organizations and
individuals trading medical devices shall be responsible for the safety and quality
of medical devices they trade.
2. Holders of the
registration numbers shall:
a) Publish the applied
standards or conduct the registration of medical devices according to
regulations of this Decree;
b) Establish and maintain
the medical devices warranty providers or conclude contracts with medical
devices warranty providers;
c) Formulate and retain
medical devices supervision dossiers and trace the origin of medical devices
according to regulations in this Decree, except for disposable medical devices
as prescribed by the owners of the medical devices;
d) Print sufficiently and
accurately information about the products on their labels or their enclosed
documents according to laws on labeling and provisions of this Decree;
dd) Promptly give
sufficient and accurate warning about the risks of causing bad effect on users’
health and on the environment ; guide the sellers and the consumers to prevent;
provide information about requirements applicable to the transport, storage and
use of medical devices;
e) Promptly terminate the
free sale of the medical devices, notify relevant parties and take measures to
handle or eliminate the issues or recall the defective equipment as provided
for in this Decree. In cases where medical devices have to be destroyed, such
destruction must comply with laws on environmental protection and relevant law
provisions. The owners of the registration numbers shall pay fully the cost of
such destruction activity;
g) Comply with laws and
decisions on inspection issued by competent agencies;
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i) Take responsibility
for ensuring that the following papers are kept valid during the validity of
the registration numbers:
- The Certificate of
conformity with quality control standards of the establishment producing the
medical devices;
- The Certificate of free
sale, applicable to Class B, C or D imported medical devices;
- The power of attorney,
except for cases specified in point a clause 1 Article 21 of this Decree;
- The Certificate of
eligibility to provide warranty.
k) Other obligations as
prescribed by laws.
3. The representative
offices of the holders of the registration numbers shall fully implement the
obligations specified in clause 2 of this Article.
Chapter XI
IMPLEMENTARY CLAUSE
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1. This Decree comes into
effect from July 01, 2016.
2. Clause 10 Article 12
of Decree No. 89/2006/ND-CP dated August 30, 2006 by the Government shall be
annulled by the effect of this Decree.
Article 68.
Transitional clause
1. A producer of medical
devices which has operated before the effective date of this Decree may
continue its operation, provided that the declaration of eligibility to produce
medical devices is made before July 01, 2017. Particularly regarding
regulations on the quality control system: the producers of medical devices
shall complete the application of the ISO 9001 quality control system before
January 01, 2018 and the ISO 13485 the quality control system before January
01, 2020.
2. Trading establishments
which has operated before the effective date of this Decree may continue their
operation, provided that the declaration of eligibility to trade medical
devices has been made according to regulations in this Decree before January
01, 2017.
3. Providers of medical
devices services that have operated before the effective date of this Decree
may continue their service provision, provided that they have submitted the
application for declaration of eligibility to provide consultancy about medical
devices technology or of the eligibility to conduct the inspection/calibration
of medical devices before July 01, 2017.
4. Medical devices
produced in Vietnam or imported into Vietnam before the effective date of this
Decree are allowed to be sold freely until it is disposed as prescribed in
clause 1 Article 22 of the Law on the management and use of State-owned
property or until the expiry date written on the certificate of registration.
5. The issuance of the
license for importing medical devices or the issuance of the registration
number of medical devices which is domestically produced or in vitro diagnostic
reagents shall comply with current law provisions until the expiration of the
period specified in clause 6 of this Article. Validity periods:
a) An import license
shall be effective until June 30, 2017, for Class A medical devices, or
December 31, 2017, for Class B, C and D medical devices, except for cases
specified in clause 1 Article 42 of this Decree;
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6. Declarations of
applied standards for Class A medical devices shall be received since January
01, 2017 and the corresponding certifications of declaration shall be effective
since July 01, 2017; the application for registration of Class B, C or D
medical devices shall be received since July 01, 2017 and the registration numbers
of medical devices shall be effective from January 01, 2018.
7. The labels of the
medical devices produced in Vietnam or imported into Vietnam before the date
specified in clause 5 of this Article are accepted until the expiry date of the
medical devices or until the medical devices are disposed as prescribed in
clause 1 Article 22 of the Law on the management and use of State-owned
property or until the expiry date written on the certificate of registration.
Article 69.
Responsibility for guiding and implementing
1. The Minister of Health
shall be responsible for guiding and monitoring the implementation of this
Decree.
2. Ministers, Heads of
ministerial-level agencies, Heads of Governmental agencies, Presidents of
People’s Committees of all levels and relevant agencies, organizations and
individuals shall be responsible for implementing this Decree./
ON BEHALF OF THE GOVERNMENT
THE PRIME MINISTER
Nguyen Xuan Phuc
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ANNEX I
FORMS OF DECLARATIONS, APPLICATIONS FOR LICENSING, APPLICATIONS
FOR ISSUANCE OF THE CERTIFICATE OF REGISTRATION
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
Form No. 01
Declaration of
eligibility for medical device classification.
Form No. 02
Declaration of eligibility
to produce medical devices.
Form No. 03
Declaration of applied
standards of Class A medical devices
Form No. 04
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Form No. 05
Application for reissuance
of the registration number of medical devices
Form No. 06
Application for
extension of the registration number of medical devices
Form No. 07
Declaration of
eligibility to trade medical devices
Form No. 08
Application for the
permit to import medical devices.
Form No. 09
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Form No. 10
Declaration of
eligibility to conduct the inspection/calibration of medical devices
Form No. 11
Application for the
Certificate of Free Sale for medical devices without a registration number
Form No. 12
Application for the
Certificate of Free Sale for medical devices with a registration number
Form No. 01
Name of establishment
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No.: .................
........1........,
...........[Date]............
DECLARATION OF ELIGIBILITY FOR MEDICAL DEVICE
CLASSIFICATION
To: The Ministry of Health (the Department of Medical
devices and Works)
1. Name of establishment:
........................................................................................
Tax codes or Number of
the representative office establishment license: ................
Address: 2..................................................................................................................
Phone number:
.................................. Fax:
...............................................................
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2. Lawful representative:
Full name:
..........................................................................................
National ID number/ Passport
number: ...................., Date of issue: .................................,
Place of issue: ..........................
Phone number (landline):
............................ Phone number (mobile): .........................
3. Classifying technician(s)3:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
Professional ability:
..................................................................................
Experience of working in
field of medical devices: .....................................month(s).
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Attachments:
1.
List of employees
2.
Certificate of
experience (working time)
3.
Qualifications of each
classifying technician
We - the establishment
declaring eligibility to classify medical devices - undertake that:
1. The declared
information is accurate, lawful and conformable. In any case where the
information is forged or falsified, we will take wholly the responsibility and
will incur penalties according to laws.
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3. Any change related to
the information in the declaration will be notified to the Ministry of Health
(the Department of Medical devices and Works).
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
2. The address written on
the enterprise registration certificate is required
3. All the technicians
shall be specified
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Name of establishment
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
.......1........, ...........[Date]..........
DECLARATION OF ELIGIBILITY TO PRODUCE MEDICAL DEVICES
To: ....................2........................
1. Name of establishment:
........................................................................................
Tax codes:
.......................................................................................
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Address of establishment:
...................4..........................................................................
Phone number:
.................................. Fax:
....................................................................
Email: …………………………….
Website (if any): .........................................................
2. Lawful representative:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
Phone number (landline):
............................ Phone number (mobile): .........................
3. Professional:
Full name:
..........................................................................................
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Professional ability:
..................................................................................
Experience of working in
field of medical devices: .....................................month(s).
4. Medical devices
produced by establishment:
No.
Name of medical devices
Expected scale
(pcs/year)
1
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Hereby declare the eligibility to produce medical devices
Attachments:
1.
List of employees
2.
Documents on assignment
and appointment of professionals of the establishment
3.
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4.
Certificates of
experience (working time) of the professionals
5.
Certificate of
conformity with quality control standards5
6.
Documents proving that
conditions of location, area and factory are suitable for the medical devices
that the establishment produces
7.
Documents about medical
devices and manufacturing and quality inspection procedures suitable for the
medical devices that the establishment produces
8.
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9.
Documents on storage
facilities for medical devices
10.
Documents on transport
vehicles for medical devices
We - the establishment declaring
eligibility to produce medical devices - undertake that:
1. The declared
information is accurate, lawful and conformable. In any case where the
information is forged or falsified, we will take wholly the responsibility and will
incur penalties according to laws.
2. Declared conditions
are ensured and maintained during our operation.
3. Any change related to
the information in the declaration will be notified to the Department of
Health.
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Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
2. Name of the Department
of Health of the province/central-affiliated city where the establishment is
headquartered
3. The address written on
the Certificate of Business registration is required
4. If such address is the
same as the one written on the Certificate of Business registration, write “tại
trụ sở” (at the headquarter)
5. If such document is
unavailable, documents specified in rows 6, 7, 8, 9 and 10 are required
Form No. 03
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
..........1.............., ...................[Date]...............
DECLARATION OF APPLIED STANDARDS FOR TYPE A MEDICAL DEVICES
To: ....................2........................
1. Name of establishment:
........................................................................................
Tax codes or Number of
the representative office establishment license: ........................
Address: ........................................................
3 .................................................................
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Email:........................................................................................................................
2. Lawful representative:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue: .................................,
Place of issue: ..........................
Phone number (landline):
............................ Phone number (mobile): .........................
3. Class A medical
devices:
Name of the medical
devices: ................................................................................
Model/code of
product:..............................................................................
Packaging specifications
(if any): ..................................................................................
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Address of establishment:
..............................................................................................
Applied standards:
..................................................................................
4. Information about the
product owner:
Name:
........................................................................................
Address:
........................................................................................
5. Information about
warranty establishment:
Name:
........................................................................................
Address:
.................................................................................................................
Phone number (landline):
............................ Phone number (mobile): .........................
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Attachments:
1.
Classification table of
medical devices
2.
Note of receipt of the
declaration of eligibility to produce medical devices
3.
Certificate of
conformity with quality control standards
4.
LETTER OF AUTHORIZATION
by the product owner
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Certificate of
eligibility to provide warranty
6.
Documents containing
technical summary of the medical devices
7.
The standard which the
product owner declares to apply
8.
Certificate of conformity
9.
Written instruction for
the medical devices
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Sample of the label of
the medical devices
We - the establishment
declaring the applied standards for Class A medical devices - undertake that:
1. The declared information
is accurate, lawful and conformable. In any case where the information is
forged or falsified, we will take wholly the responsibility and will incur
penalties according to laws.
2. Medical devices
receive quality assurance and are sold according to the declared information.
3. Any change related to
the information in the declaration will be notified to the Department of
Health.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Name of the Department
of Health of the province/central-affiliated city where the establishment is
headquartered is required
3. The address written on
the Certificate of Business registration is required
Form No. 04
Name of establishment
-------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
........1........,
...........[Date]............
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To: The Ministry of Health (Department of Medical devices
and Works).
1. Name of establishment:
........................................................................................
Tax codes or Number of
the representative office establishment license: .........................
Address: …………2.............................................................................................................
Phone number:
.................................. Fax:
.......................................................................
Email:........................................................................................................................
2. Lawful representative:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Medical devices to be
registered:
Name of the medical
devices:
................................................................................
Model:
................................................................................
Packaging specifications
(if any):
..................................................................................
Type of medical devices:
................................................................................
Name of manufacturer:
........................................................................................
Address of manufacturer:
..................................................................................................
4. Information about the
product owner:
Name:
........................................................................................
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. Information about warranty
establishment:
Name:
........................................................................................
Address:
.................................................................................................................
Phone number (landline):
............................ Phone number (mobile): .........................
Attachments:
1.
Classification table of
medical devices
2.
Certificate of
conformity with quality control standards
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
LETTER OF AUTHORIZATION
by the product owner
4.
Certificate of
eligibility to provide warranty
5.
Certificate of Free
Sale for imported medical devices
6.
Documents containing
technical summary of the medical devices
7.
Documents containing description
of technical features of the medical devices
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Written instruction for
the medical devices
9.
Summary of data on
clinical test of types C and D medical devices used by putting into human
bodies
10.
Certificate of inspection,
applicable to medical devices used for types C and D in-vitro diagnosis
11.
Sample of the label of
the medical devices
12.
Certificate of
conformity
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Decision to approve the
model
We - the establishment applying
for the registration number of medical devices - undertake that:
1. The provided
information is accurate, lawful and conformable. In any case where the
information is forged or falsified, we will take wholly the responsibility and
will incur penalties according to laws.
2. Medical devices
receive quality assurance and are sold according to the registration dossier.
3. Any change related to
the information in the application will be notified to the Ministry of Health.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. The address written on
the Certificate of Business registration is required
Form No. 05
Name of establishment
-------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
........1........,
...........[Date]............
APPLICATION FOR REISSUANCE OF REGISTRATION NUMBER OF
MEDICAL DEVICES
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Name of establishment:
........................................................................................
Tax codes or Number of
the representative office establishment license: .........................
Address: ………2.................................................................................................................
Hereby apply for
reissuance of the registration number of medical devices:
Number of the obtained
certificate of registration for
sale:..................................................
Date of issue:
.............................. Effective duration:
.......................................................
Reasons for applying for
reissuance of the registration number of medical devices:
.....................................................
We undertake that this
information above is truthful. In any case where the information is forged or
falsified, we will take wholly the responsibility and will incur penalties
according to laws.
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
2. The address written on
the Certificate of Business registration is required
Form No. 06
Name of establishment
-------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPLICATION FOR EXTENSION OF THE REGISTRATION NUMBER OF
MEDICAL DEVICES
To: The Ministry of Health (Department of Medical devices
and Works).
Name of establishment:
........................................................................................
Tax codes or Number of
the representative office establishment license: ..........................
Address: ………2..................................................................................................................
Hereby apply for
extension of the registration number of medical devices:
The obtained registration
number: .....................................................
Date of issue:
.............................. Effective duration:
.......................................................
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Date of 2nd extension:
......................... Effective duration:
.................................................
Attachments:
1.
The obtained
certificate of registration for sale
2.
Certificate of
conformity with quality control standards
3.
LETTER OF AUTHORIZATION
by the product owner
4.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5.
Income statement
We - the establishment
applying for the registration number of medical devices - undertake that:
1. The provided
information is accurate, lawful and conformable. In any case where the information
is forged or falsified, we will take wholly the responsibility and will incur
penalties according to laws.
2. Medical devices
receive quality assurance and are sold according to the registration dossier.
3. Any change related to
the information in the application will be notified to the Ministry of Health.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Location
2. The address written on the
Certificate of Business registration is required
Form No. 07
Name of establishment
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
........1........, ...........[Date]............
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To: ....................2........................
1. Name of establishment:
........................................................................................
Tax codes:
.......................................................................................
Address: …………3............................................................................................................
Transaction office (if
any): .........................................................................
2. Lawful representative:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
Phone number (landline):
............................ Phone number (mobile): .........................
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
Professional ability:
..................................................................................
4. List of medical
devices traded by the establishment:
.................................................................................................................................
.................................................................................................................................
.................................................................................................................................
Hereby declare the eligibility to trade medical devices
Attachments:
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
List of employees
2.
Documents on storage facilities
for medical devices
3.
Documents on transport
vehicles for medical devices
We - the establishment
declaring eligibility to trade medical devices - undertake that:
1. The declared
information is accurate, lawful and conformable. In any case where the
information is forged or falsified, we will take wholly the responsibility and
will incur penalties according to laws.
2. Medical devices
receive quality assurance and are sold according to the laws.
3. Any change related to
the information in the declaration will be notified to the Department of Health
of ..........5............
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
2. The name of the
Department of Health of the province/central-affiliated city where the
establishment is headquartered is required
3. The address written on
the Certificate of Business registration is required
4. All the technicians
shall be specified
5. The
province/central-affiliated city where the establishment is headquartered
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Name of importing organization/individual
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
........1........,
...........[Date]............
APPLICATION FOR THE PERMIT TO IMPORT MEDICAL DEVICES
To: The Ministry of Health (Department of Medical devices
and Works).
Name of importing organization/individual:
.......................................................................
Tax codes or National ID
number/ Passport number:
.......................................................
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Contact number:
..............................................................................
Hereby apply for the
permit to import the following medical devices:
No.
Name of medical devices
Model
Manufacturer, Country of origin
Owner
Distributor
(if any)
Quantity
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Importing purpose:
.........................................................................................
2. User:
…………...........................................................................................................
3. I/We - the importing
organization/individual - hereby undertake to:
- Take responsibility for
ensuring the quality, model, quantity of imported medical devices.
- Ensure the proper use
of imported medical devices.
I/We will take all legal
responsibility for any violation I/we commit.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
Form No. 09
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
.......1.......
...................[Date]..............
DECLARATION OF ELIGIBILITY TO PROVIDE CONSULTANCY ON
MEDICAL DEVICES TECHNOLOGY
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Provider of
consultancy about medical devices technology:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue: .................................,
Place of issue: ..........................
Address:
.................................................................................................................
Phone number:
.................................. Email: .........................................................
Professional ability:
..................................................................................
2. Scope of consultancy:
No.
Content of consultancy
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1
Consultancy about
formulation of list of medical devices
2
Consultancy about
formulation of configuration and technical features of medical devices
Hereby declare the eligibility to provide consultancy on
medical devices technology
Attachments:
1.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2.
Certificate of
experience (working time)
I undertake that:
1. The declared
information is accurate, lawful and conformable. In any case where the
information is forged or falsified, I will take wholly the responsibility and
will incur penalties according to laws.
2. Any change in the declaration
of eligibility to provide consultancy about medical devices technology will be
reported to the Ministry of Health.
The consultancy provider
(Signature and full name)
_______________
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form No. 10
Name of establishment
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
........1........,
...........[Date]............
DECLARATION OF ELIGIBILITY TO CONDUCT THE INSPECTION/CALIBRATION
OF MEDICAL DEVICES
To: The Ministry of Health (Department of Medical devices
and Works).
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Tax codes:
.......................................................................................
Address: ………2..................................................................................................................
Transaction office (if
any): .........................................................................
2. Lawful representative:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue: .................................,
Place of issue: ..........................
Phone number (landline):
............................ Phone number (mobile): .........................
3. Technicians of the
trading establishment3:
Full name:
..........................................................................................
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Professional ability:
..................................................................................
4. Scope of inspection:
List of medical devices subject to inspection by the eligible establishment
.................................................................................................................................
.................................................................................................................................
.................................................................................................................................
5. Scope of calibration:
…………………………….4...........................................................................................
.................................................................................................................................
.................................................................................................................................
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Attachments:
1.
List of employees
2.
Certificate of
conformity with testing and calibration standards
We - the establishment
declaring the eligibility to conduct the inspection/calibration of medical
devices - undertake that:
1. The declared
information is accurate, lawful and conformable. In any case where the
information is forged or falsified, we will take wholly the responsibility and
will incur penalties according to laws.
2. Declared conditions
are ensured and maintained during our operation.
3. Any change in the
declaration of eligibility to conduct inspection/calibration of medical devices
will be reported to the Ministry of Health.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
2. The address written on
the Certificate of Business registration is required
3. All the technicians shall
be specified
4. The list of medical
devices subject to inspection by the eligible establishment is required
Form No. 11
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
.......1.......,
...................[Date]..............
APPLICATION FOR THE CERTIFICATE OF FREE SALE FOR MEDICAL
DEVICES WITHOUT REGISTRATION NUMBER
To: The Ministry of Health (Department of Medical devices
and Works)
1. Name of establishment:
........................................................................................
Tax codes:
.......................................................................................
Address (according to the
business registration): ........................................................................................
2. Lawful representative:
Full name:
..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Manufacturer:
Name of establishment:
........................................................................................
Address of the
headquarter (according to the business registration):
........................................................................................
Address of manufacture
place: ............................................................................................
Phone number:
.................................. Fax:
.........................................................................
To fulfill the requirements
of the importing country, we hereby apply for the Certificate of Free Sale
(CFS) for the following medical devices:
No.
Name of medical devices
Model
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Importing country
1
2
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
We commit ourselves to
taking legal responsibility for the information declared above.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
Form No. 12
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
.......1.......
...................[Date]..............
APPLICATION FOR THE CERTIFICATE OF FREE SALE FOR MEDICAL
DEVICES WITH REGISTRATION NUMBER
To: The Ministry of Health (Department of Medical devices
and Works)
1. Name of establishment:
........................................................................................
Tax codes:
.......................................................................................
Address (according to the
business registration):
........................................................................................
2. Lawful representative:
Full name: ..........................................................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Manufacturer:
Name of establishment:
........................................................................................
Address of the
headquarter (according to the business registration):
........................................................................................
Address of manufacture
place:
............................................................................................
Contact number:
.......................................................... Fax:
...............................................
To fulfill the
requirements of the importing country, we hereby apply for the Certificate of
Free Sale (CFS) for the following medical devices:
No.
Name of medical devices
Model
...
...
...
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Registration number
Importing country
1
2
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
We commit ourselves to
taking legal responsibility for the information declared above.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
ANNEX II
LIST OF EMPLOYEES
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
.......1.......
...................[Date]..............
LIST OF EMPLOYEES
Name of establishment:
.................................
Address: ...................................................................................
No.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Position
Qualification
Experience of working in field of medical
devices
Training in medical devices
Unit
Working period
Position
Main task
Name of training institution
...
...
...
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Qualification
Form of training
Time of training
1
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
ANNEX III
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
.......1.......
...................[Date]..............
CERTIFICATE OF WORKING TIME
To: ....................2........................
My name is: ........................................................................................
Date of birth:
.................................................
National ID number/
Passport number: ...................., Date of issue:
................................., Place of issue: ..........................
I hereby apply for your
verification of the following information:
I am working/worked for:
...........................................................
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Position:
...................................................
Main task:
.............................................
.................................................................................................................................
.................................................................................................................................
I look forward to
your support.
Best regards!
.............., ...................[Date]..............
VERIFIED BY
(Signature, full name, verification
of the unit)
APPLICANT
(Signature and full name)
...
...
...
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1. Location
2. Name of the unit where
the applicant works is required
ANNEX IV
MODELS OF NOTES OF RECEIPT OF AN APPLICATION, CERTIFICATE
OF REGISTRATION FOR SALE
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
Form No. 01
Note of receipt of the declaration
of eligibility for medical device classification
Form No. 02
Note of receipt of the
declaration of eligibility to produce medical devices
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Note of receipt of the
declaration of applied standards for Class A medical devices
Form No. 04
Note of receipt of the
application for registration number of medical devices
Form No. 05
Note of receipt of the
declaration of eligibility to trade medical devices
Form No. 06
Note of receipt of the application
for the permit to import medical devices
Form No. 07
Note of receipt of the
application for declaration of eligibility to provide consultancy on medical
devices
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Note of receipt of the declaration
of eligibility to conduct the inspection/calibration of medical devices
Form No. 09
The Certificate of
registration for sale
Form No. 01
THE MINISTRY OF HEALTH
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
CERTIFICATION OF DECLARATION OF ELIGIBILITY FOR
MEDICAL DEVICE CLASSIFICATION
1. Name of the establishment:
........................................................................................
2. Address:
.................................................................................................................
3. Phone: .................................
Fax:
....................................................................................
4. Number of the
application of the establishment: .........................................
Date: ............
5. Components of the
application:
1.
Declaration of
eligibility for medical device classification
□
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
List of employees
□
3.
Certificate of working
time
□
4.
Qualifications of each
classifying technician
□
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
RECEIVING OFFICER
(Signature, position and full name)
Form No. 02
DEPARTMENT OF HEALTH OF ....1......
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
.......1........, ...........[Date]..........
CERTIFICATE OF DECLARATION OF ELIGIBILITY TO PRODUCE
MEDICAL DEVICES
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Address: .................................................................................................................
3. Phone:
................................. Fax:
.................................................................................
4. Number of the
application of the establishment: .........................................
Date: .......
5. Name of the medical
devices to be produced by the establishment:
.........................................................................................................................................
6. Components of the
application:
1.
Declaration of
eligibility to produce medical devices
□
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
List of employees
□
3.
Documents on assignment
and appointment of professionals of the establishment
□
4.
Certificate of working
time
□
5.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
□
6.
Certificate of conformity
with quality control standards
□
7.
Documents proving that
conditions of location, area and factory are in conformity with the
requirements of medical devices that the establishment produces
□
8.
Documents about medical
devices and manufacturing and quality inspection procedures suitable for the
medical devices that the establishment produces.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
9.
Contracts with eligible
establishments for conducting quality inspection of medical devices that the establishment
produces
□
10.
Documents on storage
facilities for medical devices
□
11.
Documents on transport
vehicles for medical devices
□
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
RECEIVING OFFICER
(Signature, position and full name)
_______________
1. Name of the Department
of Health of the province/central-affiliated city where the establishment is
headquartered is required
2. Location
Form No. 03
DEPARTMENT OF HEALTH OF ....1......
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
CERTIFICATE OF DECLARATION OF APPLIED STANDARDS FOR TYPE A
MEDICAL DEVICES
1. Name of the
establishment: ........................................................................................
2. Address:
.................................................................................................................
3. Number of the
application of the establishment: ................................. Date:
................
4. Class A medical
devices:
Name of the medical
devices:
................................................................................
Model/code of product:..............................................................................
Name of manufacturer:
........................................................................................
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Applied standards:
..................................................................................
5. Information about the
product owner:
Name: ........................................................................................
Address:
........................................................................................
6. Information about
warranty establishment:
Name of establishment:
........................................................................................
Address:
.................................................................................................................
Phone number (landline):
............................ Phone number (mobile): .........................
7. Components of the
application:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Application for
declaration of applied standards of Class A medical devices
□
2
Classification table of
medical devices
□
3
Note of receipt of the
declaration of eligibility to produce medical devices
□
4
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
□
5
LETTER OF AUTHORIZATION
by the product owner
□
6
Certificate of eligibility
to provide warranty
□
7
Documents containing
technical summary of the medical devices
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
8
The standard which the
product owner declares to apply
□
9
Certificate of
conformity
□
10
Written instruction for
the medical devices
□
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Sample of the label of
the medical devices
□
RECEIVING OFFICER
(Signature, position and full name)
_______________
1. Name of the Department of
Health of the province/central-affiliated city where the establishment is
headquartered is required
2. Location
Form No. 04
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
Hanoi, [date]
RECEIPT NOTE FOR THE APPLICATION FOR REGISTRATION NUMBER OF
MEDICAL DEVICES
1. Name of establishment:
........................................................................................
2. Address: .................................................................................................................
3. Number of the
application of the establishment: ................................ Date:
................
4. Application for
registration for sale of medical devices in different cases:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Application for
issuance of the registration number
□
2.
Application for
extension of the registration number
□
3.
Application for
reissuance of the registration number
□
5. Components of the application:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Application for the
registration number
□
2.
Classification table of
medical devices
□
3.
Certificate of
conformity with quality control standards
□
4.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
□
5.
Certificate of
eligibility to provide warranty
□
6.
Certificate of registration
for imported medical devices
□
7.
Documents containing
technical summary of the medical devices
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
8.
Documents containing description
of technical features of the medical devices
□
9.
Written instruction for
the medical devices
□
10.
Summary of data on
clinical test of types C and D medical devices used by putting into human
bodies
□
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Certificate of inspection,
applicable to medical devices used for types C and D in-vitro diagnosis
□
12.
Sample of the label of
the medical devices
□
13.
Certificate of
conformity
□
14.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
□
RECEIVING OFFICER
(Signature, position and full name)
Form No. 05
DEPARTMENT OF HEALTH OF ....1......
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
...
...
...
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CERTIFICATE OF DECLARATION OF ELIGIBILITY TO TRADE MEDICAL
DEVICES
1. Name of the trading
establishment:
................................................................................
2. Address:
.................................................................................................................
4. Number of the
application of the establishment: .........................................
Date: .........
4. Components of the
application:
1.
Declaration of
eligibility to trade medical devices
□
...
...
...
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List of employees
□
3.
Certificate of working
time
□
4.
Qualifications
pertaining to medical devices technology or medical devices management of the
professionals
□
5.
...
...
...
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□
6.
Documents on transport
vehicles for medical devices
□
RECEIVING OFFICER
(Signature, position and full name)
_______________
1. Name of the Department of
Health of the province/central-affiliated city where the establishment is
headquartered is required
...
...
...
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Form No. 06
THE MINISTRY OF HEALTH
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: ............./NKTTBYT
Hanoi, [date]
RECEIPT NOTE FOR THE APPLICATION FOR THE PERMIT TO IMPORT
MEDICAL DEVICES
1. Name of importing
organization/individual:
....................................................................
2. Tax codes or National
ID number/ Passport number:
....................................................
...
...
...
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4. Medical devices to be
imported: ..................................................................
No.
Name of medical devices
1.
2.
...
...
...
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Form No. 07
THE MINISTRY OF HEALTH
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
Hanoi, [date]
CERTIFICATE OF DECLARATION OF ELIGIBILITY TO PROVIDE
CONSULTANCY ON MEDICAL DEVICES TECHNOLOGY
1. Provider of
consultancy about medical devices technology:
...
...
...
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Address:
.................................................................................................................
Phone:
....................................................................................................
2. Scope of consultancy:
.......................................................................................
3. Components of the
application:
1.
Application for certificate
of eligibility to provide consultancy
□
2.
Qualifications of the
consultancy provider
...
...
...
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3.
Certificate of working
time
□
RECEIVING OFFICER
(Signature, position and full name)
Form No. 08
THE MINISTRY OF HEALTH
-----------
...
...
...
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No.: .................
Hanoi, [date]
CERTIFICATE OF DECLARATION OF ELIGIBILITY TO CONDUCT THE
INSPECTION/CALIBRATION OF MEDICAL DEVICES
1. Name of the establishment
conducting the inspection/calibration:
.........................................................................
2. Address:
.................................................................................................................
3. Phone:
....................................................................................................
4. Scope of inspection:
.......................................................................................
5. Scope of calibration:
.......................................................................................
...
...
...
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1
Application for
certificate of eligibility to conduct inspection/calibration
□
2
List of employees
□
3
Certificate of
conformity with testing and calibration standards
□
...
...
...
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RECEIVING OFFICER
(Signature, position and full name)
Form No. 09
THE MINISTRY OF HEALTH
-----------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: .................
Hanoi, [date]
...
...
...
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Pursuant to Decree No.
36/2016/NĐ-CP dated May 15, 2016 by the Government on management of medical
devices.
The Ministry of Health issues
the certificate of registration for sale of new medical devices as follows:
1. Name of medical
devices:
2. Model/code of product:
3. Packaging
specifications (if any):
4. Type:
5. Name and address of
the manufacturer:
6. Name and address of
the product owner:
7. Name and address of
the holder of the registration number:
...
...
...
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The registration number
is effective from:.........................to..........................
Receiver:
.............
[POSITION OF THE SIGNER]
[Full name, title]
(Verified with seal or digital signature)
ANNEX V
CLASSIFICATION OF MEDICAL DEVICES
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
[Name].....1.......
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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........4........,
...........[Date]............
CLASSIFICATION OF MEDICAL DEVICES
To: ....................5........................
Pursuant to Decree No.
36/2016/NĐ-CP dated May 15, 2016 by the Government on management of medical
devices;
Rules for classification:
..........................6............................................
We hereby classify
medical devices as follows:
No.
Name of medical devices
...
...
...
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Manufacturer, Country of origin
Owner
Type
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Receiver:
.............
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Name of the
establishment which has declared the eligibility to classify medical devices is
required
2. Symbol of the document
containing the classification result which is under the management of the
eligible establishment
3. Code of the
establishment eligible to classify is the number of the certificate of
declaration of eligibility for medical device classification issued by the
Ministry of Health
4. Location
5. Name of the establishment
applying for classification of medical devices
6. The rules used for
classifying medical devices as guided by the Ministry of Health shall be
specified
...
...
...
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ANNEX VI
LETTER OF AUTHORIZATION
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
Name and address of the
product owner
...................[Date]..............
LETTER OF AUTHORIZATION
To: ......................................
We, (name and address
of the owner), as the product owner, hereby authorize (name and address
of the establishment declaring the applied standards or applying for
registration number) to sell in Vietnam’s market the following medical
devices:
...............(the medical devices shall be listed1)............
We hereby undertake to
provide and assist the fulfillment of requirements related to the information
and quality and ensure the requirements pertaining to warranty and maintenance
and supply of materials and substitutes for such medical devices. This LETTER
OF AUTHORIZATION is effect until: ........... [date]
...
...
...
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Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. The list of medical
devices under authorization may be performed as an annex enclosed with the LETTER
OF AUTHORIZATION
ANNEX VII
CERTIFICATE OF ELIGIBILITY TO PROVIDE WARRANTY
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
Name and address of the
product owner: ...................
...................[Date]..............
...
...
...
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Name:
................................................................
Address:
.................................................................................................................
as the product owner,
hereby verify that the following establishments are eligible to provide
warranty for medical devices of ..............1................:
Name of medical devices
Name of establishment
Tax codes
Address
Phone number (landline)
Phone number (mobile)
...
...
...
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Establishment No. 1
Establishment No. 2
...
...
...
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…..
Establishment No. 1
Establishment No. 2
...
...
...
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Establishment No. 3
…..
…..
...
...
...
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Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Full name and address
of the product owner are required
ANNEX VIII
...
...
...
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Form No. 01
Documents containing
technical summary of the medical devices
Form No. 02
Technical documents for
reagents, calibration solutions, in-vitro control materials
Form No. 01
DOCUMENTS CONTAINING TECHNICAL SUMMARY OF THE MEDICAL
DEVICES
Name and address of the
establishment applying for the registration number of the medical devices
...................[Date]..............
...
...
...
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Heading
Content
1
Description of medical
devices
1.1
Description of medical
devices
Brief description of
operating principle and features and technical parameters of the devices; if the
medical devices involves novel technology, the description of such technology
shall be provided (for example nanotechnology)
1.2
List of accessories and
fittings
...
...
...
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1.3
Purposes/Instruction
Purposes of the medical
devices and instruction for use thereof
1.4
Instruction
Summary of instruction
to use the devices according to the Instruction sheet or the Information
sheet of the medical devices
1.5
Contraindications
Information about
contraindications - cases where the devices must not be used so as for the
safety of the patient, e.g. due to anamnesis or physiological features of the
patient, etc.; in accordance with the contents approved at the country of
manufacture and displayed on the label of the devices
...
...
...
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Warnings and cautions
Warnings and cautions
when using medical devices, including preventive measures for protecting the
patient from hazards of using the medical devices; this may be warnings about
the risks or bad effects of misuse of such medical devices and preventive
measures
1.7
Possible bad effects
Information about bad
effects related to the use of medical devices which is recorded via clinical testing
and post-marketing supervision of such medical devices
2
Information about
products sold in various countries (if any)
Information about
countries which have approved the sale of products and about the first
country granting registration/approving the sale of medical devices
...
...
...
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Instruction which has
been registered in other countries (if any)
List of countries which
have granted registration of sale, enclosed with the instruction which has been
approved in such country; date of issue of registration
4
Information about the
noticeable safety/operation of medical devices products
- Information about
quantity of reports on bad effects related to the use of medical devices;
Measures of recall/ post-marketing adjustment which have been carried out at
the request of regulatory bodies of various countries;
- If the medical
devices contains any of the following component, these information shall be
additionally provided:
Cell, animal or human tissue
or their derivatives used as not alive - for example artificial heart valve
from pig, catgut…;
Cells, tissues and or
derivatives from micro-organisms or recombinant - eg skin inflation products
based on hyaluronic acid obtained from bacterial fermentation process ...;
There are irritant or ionized ingredients - eg X-ray; or non-ionizing - ag
laser, ultrasound ...
We - the applicant for
registration - undertake that the information provided is truthful and we will take
legal responsibility for such information.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
Form No. 02
TECHNICAL DOCUMENTS FOR REAGENTS, CALIBRATION SOLUTIONS, IN-VITRO
CONTROL MATERIALS
Name and address of the
establishment applying for the registration number of the medical devices
...................[Date]..............
No.
Heading
...
...
...
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I
General information
about medical devices
1.1
General description
Introduction of medical
devices, purposes, products for use in combination (if any)
1.2
History of marketing of
the product
Name of the first
country to be licensed and year of licensing
1.3
...
...
...
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Use purposes/ instructions
which are planned to be displayed on the label or the instruction sheet
1.4
List of countries
obtaining the permit
List of countries which
have obtained the permits and the years of licensing
1.5
Conditions of applications
which have been submitted but have not obtained the permits
List of countries which
have submitted the applications but have not obtained the permits
1.6
Important information
related to the safety and effectiveness of the products
...
...
...
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II
Description of
medical devices
2.1
Description of medical
devices
Description of
operating principle and technical features and parameters of the medical
devices
2.2
Instruction
Summary of instruction
to use the devices according to the Instruction sheet or the Information
sheet of the medical devices
2.3
...
...
...
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Information about cases
where the devices must not be used so as for the safety of the patient, e.g.
due to anamnesis or physiological features of the patient, etc.; in
accordance with the contents displayed on the label of the devices
2.4
Warnings and cautions
Warnings and cautions
when using medical devices, including preventive measures for protecting the
patient from hazards of using the medical devices; this may be warnings about
the risks or hazards of misuse of such medical devices and preventive
measures
2.5
Possible bad effects
Information about bad
effects related to the use of medical devices which is recorded via clinical
testing and post-marketing supervision of such medical devices
2.6
Alternative measures
(if any)
...
...
...
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2.7
Information about raw
materials
List of raw materials
of products and description about them
2.8
Relevant technical
parameters
Characteristics about
the efficiency and technical parameters including: detection limit, trueness and
precision, sensitivity, specificity, reliability and other factors; other
technical parameters including chemical, physical, biological factors,
sterilization, stability (useful life), preservation, transport, packaging.
III
Production of medical
devices
3.1
...
...
...
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Name of manufacturers
involving in the manufacture and the applicable quality control system
3.2
Information about the
safety of the product
Safety note. If the product
has biological components, the manufacturer shall make a list of such
biological components (derived from human or animals) and undertake/declare
having conducted inspection of such factors according to the standards
prescribed by the company.
3.3
Manufacturing process
General plans on
manufacture and control of product quality.
Note of inspection of
finished products.
3.4
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Objectives, results and
conclusion about the stability of the product
IV
Research reports
4.1
Pre-clinical researches
Objectives, methods,
results and conclusion about the pre-clinical researches
4.2
Clinical researches and
clinical evidences (if any)
Objectives, methods,
results and conclusion about the clinical researches
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References
List of references
We - the applicant for
registration - undertake that the information provided is truthful and we will
take legal responsibility for such information.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
ANNEX IX
TABLE OF DATA ON CLINICAL TEST OF MEDICAL DEVICES
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
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...................[Date]..............
DATA ON CLINICAL TEST OF MEDICAL DEVICES
No.
Heading
Content
1
Name of medical devices
2
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3
Technology used for the
devices
4
Component materials
5
Clinical instruction
and application
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6
Use purposes
7
Instructions about use
effects
8
Expected useful life of
the devices
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Warnings and cautions
for use of the devices during the conduct of treatment
10
Analysis and assessment
of level of risks/usefulness of the devices
11
Evaluation of potential
risks of the devices
12
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13
Similar uses of the
devices upon the same safety standards, taking into account moral factors
14
Relevant evidences and
clinical evaluation
15
Information about the
manufacture of the devices: information about the manufacturing process,
manufacturing conditions, means used for the manufacture, packaging,
labeling, storage, preservation and transport.
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We - the applicant for
registration - undertake that the information provided is truthful and we will
take legal responsibility for such information.
Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Name and address of the
establishment
ANNEX X
REPORT ON SALE OF MEDICAL DEVICES
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: .................
........1........,
...........[Date]............
REPORT ON SALE OF MEDICAL DEVICES
To: The Ministry of Health (Department of Medical devices
and Works).
Name of the holder of the
registration number:
....................................................................
Tax codes or Number of
the representative office establishment license: ...........................
Address:
.................................................................................................................
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Name of the lawful
representative of the establishment:
...................................................................................
Phone number:
.................................. Phone number (mobile): ..........................................
.... I - the holder of
the registration number....... - hereby present the sale of medical devices
during the effect of the registration number as follows:
No.
Name of medical devices
Model
Quantity
Manufacturer, Country of manufacture
Owner
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Registration number
1
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Other contents:
1. Errors occurring during
the sale of the medical devices:
2. Changes during the
sale:
We - the establishment
selling medical devices - undertake that the information provided is truthful
and we will take legal responsibility for such information.
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Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
ANNEX XI
COMMITMENT TO PROVIDING THE WARRANTY AND MAINTENANCE AND
PROVIDING MATERIALS SERVING THE USE OF MEDICAL DEVICES
(Enclosed with Decree No. 36/2016/NĐ-CP dated May 15, 2016 by the
Government)
Name of establishment
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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........1........, ...........[Date]............
COMMITMENT
To: The Ministry of Health (Department of Medical devices
and Works)
Name:
........................................................................................
Tax codes: .......................................................................................
Address:
.................................................................................................................
Lawful representative:
...................................................................................
Contact number:
..............................................................................
:
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Name of the medical
devices:
................................................................................
Registration number:
.................................. Date of issue:
.....................................
.........3............
cannot continue operating but we are still capable of quality assurance of such
medical devices, we, therefore, hereby commit to:
- Taking responsibility
for ensuring the quality, model, quantity of imported medical devices issued
with the registration number.
- Selling medical devices
for not exceeding 24 months.
- Taking responsibility
for providing warranty and maintenance of medical devices.
- Providing materials and
substitute fittings for 8 years during the use of the devices.
- Fulfilling requirements
for technicians and ensuring the effectiveness and the safety of medical
devices towards the operators and the environment, ensuring the unchanging of
quality of the imported devices in conditions pertaining to facilities,
transport vehicles. Ensuring the fulfillment of requirements for labels of
medical devices.
- Ensuring the proper use
of medical devices. Facilitating the inspection of competent authorities.
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Legal representative of establishment
(Signature) [full name, title]
(Verified with seal or digital signature)
_______________
1. Location
2. Name of the
distributing establishment
3. Nam of the product
owner