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MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 10/2023/TT-BYT
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Hanoi, May 11,
2023
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CIRCULAR
AMENDMENTS TO CERTAIN ARTICLES OF CIRCULAR NO.
19/2021/TT-BYT DATED NOVEMBER 16, 2021 OF THE MINISTER OF HEALTH ON TEMPLATES
OF DOCUMENTS AND REPORTS ON IMPLEMENTATION OF DECREE NO. 98/2021/ND-CP DATED
NOVEMBER 08, 2021 OF THE GOVERNMENT ON MANAGEMENT OF MEDICAL DEVICES
Pursuant to Decree No. 95/2022/ND-CP dated
November 15, 2022 of the Government on functions, tasks, powers and
organizational structure of the Ministry of Health of Vietnam;
Pursuant to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices;
At the request of the Director of the Department
of Medical Equipment and Construction;
The Minister of Health hereby promulgates a
Circular on amendments to certain Articles of Circular No. 19/2021/TT-BYT dated
November 16, 2021 of the Minister of Health on templates of documents and
reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021
of the Government on management of medical devices.
Article 1. Amendments to
Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the
Minister of Health on templates of documents and reports on implementation of
Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on
management of medical devices
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a) Template No. 02.01; Template No. 02.02; Template
No. 03.01; Template No. 03.02; Template No. 03.03; Template No. 03.04 and
Template No. 03.05 are amended.
b) Template No. 05.A and Template No. 05.B are
added.
2. Amendments to Clause 4 of Article 3 concerning
regulations in Appendix IV:
a) Template No. 02.01; Template No. 02.02; Template
No. 03; Template No. 05; Template No. 07 are amended.
b) Template No. 05.A and Template No. 05.B are
added.
3. Addition of Clause 6a to Article 3:
“6a. Appendix VI.A: Template of Letter of
authorization of issuance of medical device import licences according to
regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP .”
4. Amendments to Clause 8 of Article 3 concerning
regulations in Appendix VIII:
a) Template No. 04 is amended.
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Article 2. Transitional
regulations
1. Documents contained in dossiers on declaration
of applied standards or applications for certificates of marketing
authorization or applications for import licences that are submitted before the
day on which this Circular comes into force shall be continued to be applied to
issue numbers of marketing authorization and import licences, unless amendments
to such dossiers and applications are required.
2. If letters of authorization using the prescribed
template are signed for promulgation by medical devices' owners before the day
on which this Circular comes into force, they shall be continuously included in
applications for medical device import licences.
Article 3. Implementation
clauses
1. This Circular comes into force from the day on
which it is signed.
2. Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of Health
for consideration and settlement./.
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APPENDIX I
TEMPLATE OF DECLARATION OF, DISCLOSURE OF, STATEMENT OF,
NOTIFICATION OF AND APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION NUMBER,
IMPORT LICENCE AND CERTIFICATE OF FREE SALE
(enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the
Minister of Health)
Template No. 02.01
Declaration of applied standards of class A
medical devices
Template No. 02.02
Declaration of applied standards of class B
medical devices
Template No. 03.01
Application for issuance of marketing authorization
numbers of class C and class D medical devices subject to national technical
regulations
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Application for issuance of marketing
authorization numbers of class C and class D medical devices which are
measuring instruments subject to sample approval
Template No. 03.03
Application for issuance of marketing
authorization numbers of class C and class D medical devices eligible for
quick issuance
Template No. 03.04
Application for issuance of marketing
authorization numbers of class C and class D medical devices eligible for
emergency use authorization
Template No. 03.05
Application for issuance of marketing
authorization numbers of other class C and class D medical devices
Template No. 05.A
Applications for medical device import licences
serving the implementation of the regulations in Clause 8 Article 1 of Decree
No. 07/2023/ND-CP dated March 03, 2023 of the Government on amendments to
Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on
management of medical devices (hereinafter referred to as "Decree No.
07/2023/ND-CP”)
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Orders for import of biological products for in
vitro diagnostic tests serving the implementation of the regulations in
Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Template
No. 02.01
FACILITY’S NAME
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
…1………,
day……..month……….year 20……
DECLARATION
OF APPLIED STANDARDS of class A medical Devices
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1. Name of declarant:……………………………………………………………………………
TIN or number of Licence for representative office
establishment: ……………….
Address:…………………………..3………………………….
Landline: ………………………. Fax:……………………………..
Email:……………………………………
2. Legal representative of the facility:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
Landline:………………………….Mobile phone: ……………………….
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General medical device4:
* or IVD medical device: *
Name of the medical device5:……………………
Trade name6 (if
any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code
(if any): …………..
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any):
……………………………………….
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
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Applied standard: ....................................................
4. For medical device that contains narcotic or
precursor:
Name of the narcotic or precursor: …………..Scientific
name: …………………
CAS Registry Number: ……………………………………………………..
Concentration and content of the narcotic or
precursor: .....................
Total content of narcotics and precursors in a
smallest packing unit:
……………………………………………………………………………………………………….
5. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
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6. Information about warranty facility (if any):
Name of facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
7. Number of declaration of eligibility for domestic
production of medical devices:
……………………………………………………………………………………………………….
Declaration of applied standards of class A
medical device
Enclosures:
1.
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*
2.
Letter of authorization of the owner of the
medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Documentation of brief technical description of
the medical device in Vietnamese
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5.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
*
6.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, manufacturing process and clinical
and preclinical research reports including reports on the stability of
reagents, calibrators and in vitro control materials.
*
7.
Standard version declared to be applied by the
owner of the medical device
*
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Certificate of conformity with standards
*
9.
For a medical device manufactured in Vietnam:
result of evaluating chemical, physical and microbiological parameters and
other parameters granted by a qualified facility according to the provisions
of law on conformity assessment, or Certificate of quality assessment issued
by a competent authority of Vietnam for in vitro diagnostic medical devices
*
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese.
*
11.
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*
12.
Certificate of free sale for the imported medical
device
*
We hereby declare that:
1. The declared information is accurate and legal
according to the
regulations.
We
will wholly be responsible for any falsification and will face penalties
according to regulations of law.
2. We ensure the quality of the medical device and
trade thereof according to the declaration.
3. Any changes related to the declaration will be
updated in accordance with regulations.
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
___________________
1 Geographic name
2 Department of Health of the province
where the facility is located
3 The address written on the business
registration certificate
4 Non-IVD medical device
5 Specify name of the medical device in
Vietnamese in accordance with uses of the medical device, unless its name
cannot be translated into Vietnamese.
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Template
No. 02.02
FACILITY’S NAME
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
…1………,
day……..month……….year 20……
DECLARATION OF APPLIED STANDARDS OF CLASS B MEDICAL
DEVICES
To: …………………………2…………………………
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TIN or number of Licence for representative office
establishment: ……………….
Address:…………………………..3………………………….
Landline: ………………………. Fax:……………………………..
Email:……………………………………
2. Legal representative of the facility:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Class B medical device:
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Name of the medical device5:…………………………………
Trade name6 (if
any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if
any): …………..
Model:…………………………………………………………………………
Product code (if any):
……………………………………………………..
Packing specification (if any):
……………………………………….
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of
manufacturer:……………………………………………………………………………
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4. For medical device that contains narcotic or
precursor:
Name of the narcotic or precursor: …………..Scientific
name: …………………
CAS Registry Number: ……………………………………………………..
Concentration and content of the narcotic or
precursor: .....................
Total content of narcotics and precursors in a
smallest packing unit: .....................
………………………………………………………………………………………………………..
5. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
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Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
7. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
Declaration of applied standards of class B
medical device
Enclosures:
1.
ISO 13485 Certificate
*
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Letter of authorization of the owner of the medical
device
*
3.
Confirmation of eligibility for warranty
*
4.
Documentation of brief technical description of
the medical device in Vietnamese
*
5.
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*
6.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, manufacturing process and clinical
and preclinical research reports including reports on the stability of
reagents, calibrators and in vitro control materials.
*
7.
Standard version declared to be applied by the
owner of the medical device
*
8.
Certificate of conformity with standards
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9.
For a medical device manufactured in Vietnam:
result of evaluating chemical, physical and microbiological parameters and
other parameters granted by a qualified facility according to the provisions
of law on conformity assessment, or Certificate of quality assessment issued
by a competent authority of Vietnam for in vitro diagnostic medical devices
*
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese.
*
11.
Template of label on the medical device
*
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Certificate of free sale for the imported medical
device
*
We hereby declare that:
1. The declared information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
2. We ensure the quality of the medical device and
trade thereof according to the declaration.
3. Any changes related to the declaration will be
updated in accordance with regulations.
Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or digital signature
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___________________
1 Geographic name
2 Department of Health of the province
where the facility is located
3 The address written on the business registration
certificate
4 A medical device, not an in vitro
diagnostic medical device
5 Specify name of the medical device in
Vietnamese in accordance with uses of the medical device, unless its name
cannot be translated into Vietnamese.
6 Specify the trade name given by the
owner of the medical device.
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Name of Applicant
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
…1………,
day……..month……….year 20……
APPLICATION
FOR ISSUANCE OF NUMBERS OF MARKETING AUTHORIZATION OF CLASS C AND CLASS D
MEDICAL DEVICES SUBJECT TO NATIONAL TECHNICAL REGULATIONS
To: The Ministry of
Health
1. Name of the
applicant:……………………………………………………………………………
TIN or number of Licence for representative office establishment:
……………….
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Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
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Model:…………………………………………………………………………
Product code (if any):
……………………………………………………..
Packing specification (if any): ……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
4. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
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5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
7. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate:………………………..
- Letter of authorization of the owner of the
medical device:……………………………
- Certificate of free sale for the imported medical
device: ……………………..
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1.
ISO 13485 Certificate
*
2.
Letter of authorization of the owner of the
medical device
*
3.
Confirmation of eligibility for warranty
*
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Certificate of free sale for the imported medical
device
*
5.
Common Submission Dossier Template (CSDT)
*
6.
Certificate of conformity with regulations
*
7.
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*
8.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
*
9.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical research reports including
reports on the stability of reagents, calibrators and in vitro control
materials.
*
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese.
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11.
Template of label on the medical device
*
The applicant hereby delares that:
1. The declared information is accurate and legal
according to the regulations. The applicant will wholly be responsible
for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical
device and trade thereof according to the application.
3. Any changes related to the application will be
updated in accordance with regulations.
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___________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 03.02
NAME OF
APPLICANT
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No. ………..
…1………,
day……..month……….year 20……
APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION
NUMBERS OF CLASS C AND CLASS D MEDICAL DEVICES WHICH ARE MEASURING INSTRUMENTS
SUBJECT TO SAMPLE APPROVAL
To: The Ministry of
Health
1. Name of the applicant:……………………………………………………………………………
TIN or number of Licence for representative office
establishment: ……………….
Address:…………………2………………………………………………………..
Tel: ……………………….Fax:……………………
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2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if
any): …………..
Model:…………………………………………………………………………
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Packing specification (if any):
……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of
manufacturer:……………………………………………………………………………
4. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
5. Information about warranty facility (if any):
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Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
7. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the
medical device:……………………………
- Certificate of free sale for the imported medical
device: ……………………..
Enclosures:
1.
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*
2.
Letter of authorization of the owner of the
medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Certificate of free sale for the imported medical
device
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5.
Common Submission Dossier Template (CSDT)
*
6.
Decision on sample approval
*
7.
Documentation of brief technical description of
the medical device in Vietnamese
*
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Technical documentation of functions and specifications
of the medical device promulgated by its owner
*
9.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical research reports including
reports on the stability of reagents, calibrators and in vitro control
materials.
*
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese.
*
11.
...
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*
The applicant hereby delares that:
1. The declared information is accurate and legal
according to the regulations. The applicant will wholly be responsible
for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical
device and trade thereof according to the application.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the applicant
(Signature (full name, title))
Confirmed by seal or digital signature
...
...
...
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___________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 03.03
NAME OF
APPLICANT
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
...
...
...
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APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION
NUMBERS OF CLASS C AND CLASS D MEDICAL DEVICES ELIGIBLE FOR QUICK ISSUANCE
To: The Ministry of Health
1. Name of the
applicant:……………………………………………………………………………
TIN or number of Licence for representative office
establishment: ……………….
Address:………………………2………………………
Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
...
...
...
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ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if
any): …………..
Model:…………………………………………………………………………
Product code (if any):
……………………………………………………..
Packing specification (if any):
……………………………………….
...
...
...
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Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of
manufacturer:……………………………………………………………………………
4. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
...
...
...
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6. Information about the marketing authorization of
the medical device:
- Document number:……………………………………
- Name of issuing
authority:……………………………………………………………………………
- Date of issue:……….…………….…………..
- Expiry
date:................…………………………….………………………....
7. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
8. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the
medical device:……………………………
...
...
...
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Enclosures:
1.
ISO 13485 Certificate
*
2.
Letter of authorization of the owner of the
medical device
*
3.
Confirmation of eligibility for warranty
...
...
...
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4.
Certificate of free sale for the imported medical
device
*
5.
Common Submission Dossier Template (CSDT)
*
6.
Certificate of quality assessment issued by a
competent authority of Vietnam for in vitro diagnostic medical devices
*
...
...
...
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Documentation of brief technical description of
the medical device in Vietnamese
*
8.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
*
9.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and manufacturing
process and clinical and preclinical research reports including reports on
the stability of reagents, calibrators and in vitro control materials.
*
10.
...
...
...
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*
11.
Template of label on the medical device
*
The applicant hereby delares that:
1. The declared information is accurate and legal
according to the regulations. The applicant will wholly be responsible
for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical
device and trade thereof according to the application.
3. Any changes related to the application will be
updated in accordance with regulations.
...
...
...
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Legal
representative of the applicant
Signature (full name, title)
Confirmed by seal or digital signature
___________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 03.04
...
...
...
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
…1………,
day……..month……….year 20……
APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION
NUMBERS OF CLASS C AND CLASS D MEDICAL DEVICES ELIGIBLE FOR EMERGENCY USE
AUTHORIZATION
To: The Ministry of
Health
1.
Name of the
applicant:……………………………………………………………………………
TIN or number of Licence for representative office
establishment:
...
...
...
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Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
...
...
...
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Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of
manufacturer:……………………………………………………………………………
4. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
...
...
...
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5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Information about circulation, emergency use
authorization of medical devices (in case of technology transfer or processing
where information about the transferred or processed products in circulation
has to be provided):
- Document number:……………………………………
- Name of issuing
authority:……………………………………………………………………………
- Date of issue:……….…………….…………..
- Expiry
date:................…………………………….………………………....
...
...
...
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…………………………………………………………………………………………………………
7. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
8. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the
medical device:……………………………
- Certificate of free sale for the imported medical
device: ……………………..
Enclosures:
1.
ISO 13485 Certificate
...
...
...
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2.
Letter of authorization of the owner of the
medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Certificate of free sale or licence for emergency
use authorization for the imported medical device.
*
...
...
...
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Document containing links of the applicant for
issuance of marketing authorization numbers
*
6.
Common Submission Dossier Template (CSDT)
*
7.
Technology transfer contract
*
8.
...
...
...
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*
9.
Certificate of product quality inspection or
assessment
*
10.
Documentation of brief technical description of
the medical device in Vietnamese
*
11.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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12.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical research reports including
reports on the stability of reagents, calibrators and in vitro control
materials.
*
13.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese.
*
14.
Template of label on the medical device
*
...
...
...
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1. The declared information is accurate and legal
according to the regulations. The applicant will wholly be responsible
for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical
device and trade thereof according to the application.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the applicant
(Signature (full name, title))
Confirmed by seal or digital signature
___________________
...
...
...
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2 The address written on the business registration
certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 03.05
NAME OF
APPLICANT
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
…1………,
day……..month……….year 20……
...
...
...
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To: The Ministry of
Health
1. Name of the
applicant:……………………………………………………………………………
TIN or number of Licence for representative office
establishment: ……………….
Address:………………………2………………………
Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of
issue: ........................
...
...
...
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3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if
any): …………..
Model:…………………………………………………………………………
Product code (if any):
……………………………………………………..
Packing specification (if any):
……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
...
...
...
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Address of
manufacturer:……………………………………………………………………………
4. Information about the owner of the medical
device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
...
...
...
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- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the
medical device:……………………………
- Certificate of free sale for the imported medical
device: ……………………..
Enclosures:
1.
ISO 13485 Certificate
*
2.
Letter of authorization of the owner of the
medical device
...
...
...
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3.
Confirmation of eligibility for warranty
*
4.
Certificate of free sale for the imported medical
device
*
5.
Common Submission Dossier Template (CSDT)
*
...
...
...
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Certificate of quality assessment issued by a competent
authority of Vietnam for in vitro diagnostic medical devices
*
7.
Testing form for composition and content of
substances with antibacterial activity; assessment form for bio-efficacy of
products for chemicals and preparations serving the only purpose of
sterilization.
*
8.
Documentation of brief technical description of
the medical device in Vietnamese
*
9.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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*
10.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical research reports including
reports on the stability of reagents, calibrators and in vitro control
materials.
*
11.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese.
*
12.
Template of label on the medical device
...
...
...
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The applicant hereby delares that:
1. The declared information is accurate and legal
according to the regulations. The applicant will wholly be responsible
for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical
device and trade thereof according to the application.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the applicant
(Signature (full name, title))
Confirmed by seal or digital signature
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 05.A
Application for
medical device import licence serving the implementation of regulations in
Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Name of
importer
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ……../……1
...
...
...
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Application
for import licence
To: The Ministry of
Health
Importer:
Address:
TIN:
Tel:
Fax:
Legal representative:
Landline:
Mobile phone:
...
...
...
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Landline:
Mobile phone:
We hereby apply for the licence to import the
following medical devices:
No.
Name of medical
device
Model
Manufacturer,
country of manufacture
Manufacturer,
country of product owner
Distributor,
country of distribution
(if any)
Year of
production
...
...
...
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1. Purpose of import:
2. Time limit of certificate of free sale:
3. Time limit of ISO certificate:
...
...
...
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5. We hereby declare that:
- We are responsible for the consistency of the
quality, model, quantity and brand-newness of the imported medical devices with
the application.
- We are responsible for warranty on medical
devices and provision of chemicals, materials and spare parts during the use of
such medical devices.
- We have qualified personnel in charge of
effectiveness and safety of medical devices for users and environment, and
ensure that the quality of the imported medical devices is not affected during
transport and in our facilities. We fully comply with regulations on goods
labeling.
- The imported medical devices are used in
accordance with the application. We will facilitate inspection by competent
authorities.
We will be responsible before law for breach of the
above-mentioned commitments.
Importer
(Signature, full name and seal)
...
...
...
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___________________
1 Abbreviation of the importer
2 Name of province or city where the
importer is located
Template
No. 05.B
Order for import of
biological products for in vitro diagnostic test serving the implementation of
the regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Name of importer
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
...
...
...
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Order for
import
To: The Ministry of
Health
(Name of importer) herein requests the Department
of Medical Equipment and Works – of the Ministry of Health to consider granting
an approval in order that (the importer) may import the following biological
products for in vitro diagnostic test which are not registered:
Name of biological
product for in vitro diagnostic test, composition, content, dosage form,
packing specification
Unit
Import quantity
Date of production
/ expiry date
...
...
...
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Name and country
of manufacturer
Name and country
of supplier
Name of entrustor
(if any) *
...
...
...
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* If the import is not entrusted, specify “No
entrustment”
………….,
day….month………. year
Director of the importer
(signature, seal)
APPENDIX IV
Template of
MEDICAL DEVICE application for DECLARATION, CERTIFICATE, IMPORT LICENCE
(enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the
Minister of Health)
Template No. 02.01
...
...
...
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Template No. 02.02
Template of application for declaration of
applied standards of class B medical devices
Template No. 03
Certificate of marketing authorization of class C
and class D medical devices
Template No. 05
Medical device import licence serving the
implementation of regulations in Clause 2 Article 48 of Decree No.
98/2021/ND-CP and Clause 12 Article 1 of Decree No. 07/2023/ND-CP
Template No. 05.A
Import licence serving the implementation of
regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Template No. 05.B
...
...
...
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Template No. 07
Certificate of free sale for the medical devices
Template
No. 02.01
….1….
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
Information
Application for declaration of applied
standards of class A medical devices
...
...
...
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Declaration
date:…………
1. Name of declarant:
......................................................................................
2. Address:…………………………………………………………………………..
3. Document number of the declarant:…………………………………
Date:…………………..
4. Class A medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if
any): …………..
Model:…………………………………………………………………………
...
...
...
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Packing specification (if any): ……………………………………….
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
Applied standard:
....................................................
5. For medical device that contains narcotic or
precursor (if any):
Name of the narcotic or precursor: …………..Scientific
name: …………………
CAS Registry Number: ……………………………………………………..
Concentration and content of the narcotic or
precursor: .....................
...
...
...
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6. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
7. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
8. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
9. Enclosures:
...
...
...
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Application form
*
2.
ISO 13485 Certificate
*
3.
Letter of authorization of the owner of the
medical device
*
4.
...
...
...
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*
5.
Standard version declared to be applied by the
owner of the medical device
*
6.
Certificate of conformity with standards
*
7.
For a medical device manufactured in Vietnam: adding
result of evaluating chemical, physical and microbiological parameters and
other parameters granted by a qualified facility according to the provisions
of law on conformity assessment, or Certificate of quality assessment issued
by a competent authority of Vietnam for in vitro diagnostic medical devices
...
...
...
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8.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
*
9.
Template of label on the medical device
*
10.
Certificate of free sale for the imported medical
device
*
...
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1 Department of Health of the province
where the applicant is located
Template
No. 02.02
...1…
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
INFORMATION
Application for declaration of applied
standards of class B medical devices
Declaration
number:…………
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1. Name of the
declarant:……………………………………………………………………………
2. Address:………………………………………………
3. Document number of the
declarant:…………………………………Date:…………………..
4. Class B medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if
any): …………..
Model:…………………………………………………………………………
Product code (if any):
……………………………………………………..
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Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of
manufacturer:……………………………………………………………………………
Applied standard:
....................................................
5. For medical device that contains narcotic or
precursor (if any):
Name of the narcotic or precursor: …………..Scientific
name: …………………
CAS Registry Number: ……………………………………………………..
Concentration, content: .....................
Total content of narcotics and precursors in a
smallest packing unit: .....................
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Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
7. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
8. Number of declaration of eligibility for
domestic production of medical devices: ……………………………………….
9. Enclosures:
1.
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*
2.
ISO 13485 Certificate
*
3.
Letter of authorization of the owner of the
medical device
*
4.
Confirmation of eligibility for warranty
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5
Standard version declared to be applied by the
owner of the medical device
*
6.
Certificate of conformity with standards
*
7.
For a medical device manufactured in Vietnam:
adding result of evaluating chemical, physical and microbiological parameters
and other parameters granted by a qualified facility according to the
provisions of law on conformity assessment, or Certificate of quality
assessment issued by a competent authority of Vietnam for in vitro diagnostic
medical devices
*
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User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
*
9.
Template of label on the medical device
*
10.
Certificate of free sale for the imported medical
device
*
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Template
No. 03
MINISTRY OF
HEALTH OF VIETNAM
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
Hanoi,
…….(date)…….
Certificate
of marketing authorization of class C and class D medical devices
Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
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The Ministry of Health hereby grants a certificate
of marketing authorization to the following brand-new medical device:
1. Name of medical device:
2. Trade name (if any):
3. Global Medical Device Nomenclature - GMDN code
(if any):
4. Type of medical device:
5. Name and address of owner of medical device:
6. Name and address of holder of marketing
authorization number:
7. Uses; name and address of warranty facility: See
attached annex.
8. Detail on medical device (model; product code;
packing specification; name of manufacturer; address of manufacturer and
country of production): See attached annex.
...
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Authority and position of signer
(signature of competent person, seal of issuer)
Full name
Page……/……
attached annex
1. Uses:
2. Name, address of warranty facility:
3. Details on medical device:
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Name of medical
device
Model
Product code
(if any)
Packing
specification (if any)
Name of
manufacturer
Address of
manufacturer
Country of
production
...
...
...
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...
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...
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Page……/……
Template
No. 05
Template of
Medical device import licence
Serving the
implementation of the regulations in Clause 2 Article 48 of Decree No.
98/2021/ND-CP and Clause 12 Article 1 of Decree No. 07/2023/ND-CP
MINISTRY OF
HEALTH OF VIETNAM
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
...
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To:
……………………………………………………
Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices.
Considering the request in Official Dispatch No.
…………. dated…………… on ………….. The Ministry of Health hereby comes to an agreement
with the request of (the applicant) on import of consignment of brand-new
medical devices. To be specific:
No.
Name of medical
device
Model/ Product
code
Manufacturer,
country of manufacture
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...
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Distributor,
country of distribution
(if any)
Quantity
Unit
...
...
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……. 1 ……… shall be responsible for
site inspection of goods quality before receipt, cooperate with Customs authority
in solving import-related issues in accordance with regulations, be responsible
for quality and safety of such goods, and use for intended puposes.
Authority and position of signer
(signature of competent person, seal of issuer)
Full name
___________________
1 Name of importer
Template
No. 05.A
TEMPLATE OF MEDICAL DEVICE IMPORT LICENCE
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MINISTRY OF
HEALTH OF VIETNAM
-------
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom – Happiness
---------------
No.
issuing medical device import licence
Hanoi,….date..….
To: ……….. Name of
importer…………
Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices.
Considering the request in Official Dispatch No.
…………. dated……………of the importer on import of medical devices. The Ministry of
Health hereby grants a licence to import the following brand-new medical
devices:
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Name of the medical device
Model
Manufacturer, country of manufacture
Manufacturer, country of product owner
Distributor, country of distribution
(if any)
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The importer must comply with the applicable
regulations on import of medical devices. The importer must comply with
regulations on labeling, and take responsibility for quantity, value and
quality of the imported medical devices in accordance with regulations of law.
This document comes into force from December 31,
2024.
AUTHORITY AND
POSITION OF SIGNER
(signature of competent person, seal of issuer)
Full name
Template
No. 05.B
Licence to
import biological products for in vitro diagnostic test
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MINISTRY OF
HEALTH OF VIETNAM
-------
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom – Happiness
---------------
No.
importing biological products for in vitro diagnostic test
Hanoi,….date..….
To: Importer ………….
Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices.
Considering the request in Order No. ………….……………of
the importer on import. The Ministry of Health hereby grants a licence to
import the following brand-new biological products for in vitro diagnostic
test:
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Unit
Date of production
/ expiry date
Use
Name and country
of manufacturer
Name and country
of supplier
Name of entrustor
(if any)
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The importer must comply with the applicable regulations
on import of biological products for in vitro diagnostic test. The importer
must comply with regulations on labeling, and concurrently take responsibility
for quantity, value and quality of the imported biological products in
accordance with regulations of law.
This document comes into force from December 31,
2024.
AUTHORITY AND
POSITION OF SIGNER
(signature of competent person, seal of issuer)
Full name
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VIETNAM
MINISTRY OF HEALTH
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
Hanoi, date...
month... year ...
CERTIFICATE OF FREE SALE
Certificate No: ……………… /CFS/BYT-TB-CT
Product Owner:
Address:
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This is to certify that the above product(s)
complies with the Medical Device regulations of Vietnam and is (are) allowed to
be sold in Vietnam.
This certificate is issued according to Decision
No: ………………
AUTHORITY AND
POSITION OF SIGNER
(signature of competent person, seal of issuer)
Full name
Page……/……
Attached Annex
Certificate of Free
sale No: …………… CFS/BYT-TB-CT
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1.
Name of Manufacturer:
Address:
2.
Name of Manufacturer:
Address:
II. Name of Product(s):
1.
Product name:
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Product code:
Market Authorization number in Vietnam:
Name of Manufacturer
2.
Product name:
Model:
Product code:
Market Authorization number in Vietnam:
Name of Manufacturer:
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Page
.........../........
APPENDIX VI.A
Letter of
authorization Template1
serving
the issuance of medical device import licence according to regulations
in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
(enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the
Ministry of Health)
………2 ……….
Day ……month……..year
LETTER OF
AUTHORISATION
To: …………………………
We, (Name and address of product owner), as
the legal manufacturer (product owner) do hereby authorize (Name and
address of the importer) to apply for import licence, import the following
medical devices:
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We commit to provide and support all information
concerning product information, product quality upon request by Vietnam
Ministry of Health (Department of Medical Equipment and Constructions) for
medical devices mentioned above.
This authorization letter is valid until: ………. date
(dd/mm/yy)
Legitimate representative of legal manufacturer
(product owner)
Signature
(Full name and title)
___________________
1 Written in both Vietnamese and English
(except for medical devices produced domestically), and other languages (if
any).
2 Information about the owner of the
medical device (the product owner)
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APPENDIX VIII
TEMPLATES OF TECHNICAL DOCUMENTS FOR MEDICAL DEVICES
(enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the
Minister of Health)
As for medical devices which are neither
reagents, calibration substances, in vitro control materials nor chemicals
and preparations serving the only purpose of disinfecting medical devices
Template No. 04
Documentation of brief technical description of
imported medical devices serving the issuance of marketing authorization
numbers
Template No. 06
Technical description of models of imported
medical devices serving the issuance of import licences
Template
No. 04
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Name and address of facility registering for
circulation of medical device
Day………month………year 20………..
No
Heading
Brief
description
1
Product description of the medical device
1.1
Prescription of the medical device
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1.2
Catalog of parts and accessories
List of parts and accessories of the medical
device
1.3
Purposes/Indications
List of purposes/indications of the medical
device
1.4
Instructions for use
Brief instructions for use of the medical device
as prescribed in the Instruction sheet or Information sheet of the medical device
...
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Contraindication
Information on the contraindication – means that
cases in which the use of the medical device must not be used for reasons of
patient safety, for example due to the patient's medical history,
physiological characteristics, etc., is in accordance with the approved
content in the country in which marketing authorization is granted and is
stated on the label of the medical device
1.6
Warnings and cautions
Warnings and cautions when using the medical
device, including preventive measures to protect patients from risks caused
by the use of the medical device. They can be warnings about adverse effects
or misuse and precautions
1.7
Adverse effects
Adverse effects related to the use of the medical
device is recorded through clinical tests and after-sales service which have
been previously performed for the medical device
2
...
...
...
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Information on the countries in which the
certificate of marketing authorization of the product is granted, or the
first country in which the certificate of marketing authorization of the
medical device is granted
3
Indications that have been registered in other
countries (if any)
List of countries in which certificates of
marketing authorization attached with the indications approved in these
countries are granted; dates of issue of these certificates
4
Notable information about the safety/operation of
the medical device
- Information on the number of reports on adverse
effects related to the use of the medical device; measures for
recall/adjustment of after-sales services implemented at the request of
regulatory authorities of some countries;
- Information about the following
components of the medical device is mandatory:
● Human or animal cells or tissues or their
derivatives intended for use in a non-viable form – e.g. artificial heart
valves from pig or cat intestines, etc.;
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5
Reports on clinical assessment of class C and D
medical devices which are not in vitro diagnostic medical devices
5.1
Clinical assessment
Reports on clinical assessment of the owners of
the medical devices in Vietnamese or English
5.2
References of the clinical assessment
List of references (if any)
We certify that the above information is true. We
will be responsible before law for the above-mentioned information.
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
Template
No. 06
Template of
TECHNICAL DESCRIPTION OF models of IMPORTED MEDICAL DEVICES
Name of
importer
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………..
…….(location),
day…… month……year…….
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TECHNICAL DESCRIPTION
OF MODELS OF IMPORTED MEDICAL DEVICES
No
Heading
Brief
description
1
Description of model of medical device
1.1
Prescription of the medical device
Brief prescription of operating principles and
features and technical parameters of the medical device; specify that if the
device uses new technologies, a description of such new technologies (e.g.
nanotechnology) should be provided.
...
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Catalog of parts and accessories (including added
chemicals)
List of parts and accessories of the medical device;
As for medical devices for which chemicals and special reagents are provided,
list of such chemicals and special reagents is required.
1.3
Purposes/ Indications
List of purposes/indications intended to be
written on the label of the imported medical device
1.4
Instructions for use
Brief instructions for use of the medical
device is in accordance with the instructions for use or information sheet of
the imported medical device
1.5
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Information on the contraindication – means
that cases in which the use of the medical device must not be used for
reasons of patient safety, for example due to the patient's medical history,
physiological characteristics, etc., is in accordance with the approved
content in the country of production and is stated on the label of the
imported medical device
1.6
Warnings and cautions
Warnings and cautions when using the medical
device, including preventive measures to protect patients from risks caused
by the use of the medical device. They can be warnings about adverse effects
or misuse and precautions
1.7
Adverse effects
Adverse effects related to the use of the
medical device is recorded through clinical tests and after-sales service
which have been previously performed for the imported medical device
2
Information of the product circulated in
countries (if any)
...
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3
Indications that have been registered in other
countries (if any)
List of countries in which certificates of
marketing authorization attached with the indications approved in these countries
are granted; dates of issue of these certificates
4
Notable information about the safety/operation
of the medical device:
- (Information on the number of reports on
adverse effects related to the use of the medical device; measures for
recall/adjustment of after-sales services implemented at the request of
regulatory authorities of some countries)
- ( Information about the following components
of the medical device is mandatory:
● Human or animal cells or tissues or their
derivatives intended for use in a non-viable form – e.g. artificial heart
valves from pig or cat intestines, etc.;
● Cells, tissues and/or derivatives of
microbial or recombinant origin – e.g. hyaluronic acid-based dermal fillers
obtained by bacterial fermentation, etc.; Contain allergic or ionizing
ingredients – e.g. X-ray; or non-ionizing - E.g. laser, ultrasound, etc.
...
...
...
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
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