List of Vietnam Law
Circular No. 57/2025/TT-BYT dated December 31, 2025 of the Ministry of Health of Vietnam guiding categorization of medical equipment by technical standards and quality
Date: 12/31/2025
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THE MINISTRY OF HEALTH OF VIETNAM
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness ---------------- |
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No. 57/2025/TT-BYT
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Hanoi, December 31, 2025
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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
This Circular provides guidelines on categorization of medical devices by technical standards and quality under Point d Clause 2 Article 146 of Decree No. 214/2025/ND-CP dated August 4, 2025 of the Government elaborating the Law on Bidding in terms of contractor selection.
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.
b) Conformity assessment results provided by:
- 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.
Article 4. Guiding categorization of medical equipment by technical standards and quality
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.
4. Group 4:
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
This Circular comes into force from February 15, 2026.
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.
b) categorize by technical standards and quality in a manner that ensures competition in each group, transparency, quality, effectiveness, and accountability as per the law.
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)./.
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PP. MINISTER
DEPUTY MINISTER (Signed and sealed) 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)
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No.
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Country, organization of reference
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1
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Food and Drug Administration (FDA) - The United States;
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2
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Therapeutic Goods Administration (TGA) - Australia
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3
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Health Canada;
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4
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Ministry of Health, Labor, and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) - Japan
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5
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Member states of EU
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6
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The United Kingdoms
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7
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Switzerland
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8
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National Medical Products Administration (NMPA) - China;
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9
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Ministry of Food & Drug Safety (MFDS) or National Institute of Medical Device Safety Information (NIDS) - South Korean.
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(This translation is for reference only)
