|
THE MINISTRY OF
HEALTH OF VIETNAM
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
----------------
|
|
No. 57/2025/TT-BYT
|
Hanoi, December
31, 2025
|
CIRCULAR
GUIDING
CATEGORIZATION OF MEDICAL EQUIMENT BY TECHNICAL STANDARDS AND QUALITY
Pursuant to Decree No. 98/2021/ND-CP dated
November 8, 2021 of the Government on management of medical device amended by
Decree No. 07/2023/ND-CP;
Pursuant to Decree No. 214/2025/ND-CP dated
August 4, 2025 of the Government elaborating the Bidding Law regarding bidder
selection;
Pursuant to Decree No. 42/2025/ND-CP dated
February 27, 2025 of the Government on functions, tasks, powers, and
organizational structures of Ministry of Health;
At request of Director of Vietnam
Infrastructures and Medical Device Administration,
The Minister of Health promulgates Circular
guiding categorization of medical devices by technical standards and quality.
Article 1. Scope
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Article 2. Basis for
determination of technical standards and quality
1. Technical standards of medical devices shall be
determined in accordance with Vietnam’s regulations on technical standards and
regulations if any of the following standards is met:
a) National standards.
b) International standards.
c) Regional standards.
d) Foreign standards.
dd) Grassroots standards.
2. Methods for determining fulfillment of technical
standards of medical devices under Clause 1 of this Article:
a) Certification for conformity according Vietnam's
regulations and technical standards, regulations.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
- International conformity assessing bodies; or
- Domestic or foreign conformity assessing bodies
legally established and operating in Vietnam.
c) Dossiers of medical device owners proving that
the medical devices satisfy technical standards at request of users.
3. Quality of medical devices is determined by the
fact that whether the medical devices are licensed for sale and operation in
one or many countries and territories.
Article 3. Principles in
categorizing medical devices by technical standards and quality
1. Categorized medical devices must satisfy
technical standards and quality according to field-specific requirements and
demands of users corresponding to the categorization under Article 4 hereof and
be licensed for legitimate sale in Vietnam.
2. Medical devices manufactured in Vietnam are
eligible for all respective groups under Article 4 hereof if they meet all
requirements below:
a) Regarding technical standards: Satisfy technical
standard requirements applicable to medical devices selected by users
corresponding to groups under Article 4 hereof.
b) Regarding quality: Be eligible for legitimate
sale in Vietnam.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
1. Group 1:
a) Regarding technical standards: Medical devices
have specific technical standards selected by users satisfactory to Clause 1
Article 2 and Point a Clause 2 Article 2 hereof.
b) Regarding quality: Medical devices are permitted
by at least 1 organization, country, or territory for sale in respective
country or territory selected by users among the lists under Appendix attached
hereto.
2. Group 2:
a) Regarding technical standards: Medical devices
have specific technical standards selected by users satisfactory to Clause 1
Article 2 and Point a Clause 2 Article 2 hereof.
b) Regarding quality: Medical devices are permitted
by at least 1 organization, country, or territory for sale in respective
country or territory selected by users beyond the lists under Appendix attached
hereto.
3. Group 3:
a) Regarding technical standards: Medical devices
have specific technical standards selected by users satisfactory to Clause 1
Article 2 and Point a or Point b Clause 2 Article 2 hereof.
b) Regarding quality: Medical devices are permitted
by at least 1 organization, a country, or territory for sale in respective
country or territory selected by users among the lists under Appendix attached
hereto.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
a) Regarding technical standards: Medical devices
have specific technical standards selected by users satisfactory to Clause 1
Article 2 and Point a or Point b Clause 2 Article 2 hereof.
b) Regarding quality: Medical devices are permitted
by at least 1 organization, country, or territory for sale in respective
country or territory selected by users beyond the lists under Appendix attached
hereto.
5. Group 5:
a) Regarding technical standards: Medical devices
have specific technical standards selected by users satisfactory to Clause 1
Article 2 and Point a or Point b or Point c Clause 2 Article 2 hereof.
b) Regarding quality: Medical devices are permitted
by an organization, a country, or territory for sale in respective country or
territory selected by users among the lists under Appendix attached hereto.
6. Group 6:
a) Regarding technical standards: Medical devices
have specific technical standards selected by users satisfactory to Clause 1
Article 2 and Point a or Point b or Point c Clause 2 Article 2 hereof.
b) Regarding quality: Medical devices are permitted
by at least 1 organization, country, or territory for sale in respective
country or territory selected by users beyond the lists under Appendix attached
hereto.
Article 5. Entry into force
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Article 6. Roadmap for
implementation
1. Relevant entities and organizations have the
responsibility to prepare necessary conditions for implementation from the
effective date hereof.
2. Categorization of medical devices by technical
standards and quality shall be implemented from January 1, 2027.
Article 7. Terms of reference
If documents referred to in this Circular are
replaced or amended, the replacing or amended version shall prevail.
Article 8. Organizing
implementation
1. Vietnam Infrastructures and Medical Device
Administration has the responsibility to take charge and cooperate with
relevant agencies and entities in implementation of this Circular.
2. Figureheads of entities categorizing medical
devices by technical standards and quality have the responsibility to:
a) decide on categorization of medical devices by
technical standards and quality in a manner in line with management and use
demands of using entities.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
3. Holders of registration number of medical
devices are responsible for document proving that medical devices fulfill
technical standards and quality under Article 2, Article 3, and Article 4
hereof.
Difficulties that arise during implementation
should be reported to the Ministry of Health (Vietnam Infrastructures and
Medical Device Administration)./.
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
APPENDIX
(Attached to
Circular No. 57/2025/TT-BYT dated December 31, 2025 of the Minister of Health guiding
categorization of medical devices by technical standards and quality)
No.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
1
Food and Drug Administration (FDA) - The United
States;
2
Therapeutic Goods Administration (TGA) -
Australia
3
Health Canada;
4
Ministry of Health, Labor, and Welfare (MHLW) or
Pharmaceuticals and Medical Devices Agency (PMDA) - Japan
5
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
6
The United Kingdoms
7
Switzerland
8
National Medical Products Administration (NMPA) -
China;
9
Ministry of Food & Drug Safety (MFDS) or
National Institute of Medical Device Safety Information (NIDS) - South
Korean.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.