Circular No. 57/2025/TT-BYT guides on classifying medical devices according to technical standards and quality, applicable to units using medical devices. The document specifies technical standards, conformity certification, and circulation of medical devices in Vietnam.
적용 범위
Units using medical devices in the healthcare sector
핵심 사항
- Medical devices must meet technical standards as prescribed in Article 2 (Article 146 Decree No. 214/2025/NĐ-CP).
- The quality of medical devices is determined based on their lawful circulation in one or more countries, territories chosen by the user unit.
- Medical devices are classified from Group 1 to Group 6 depending on technical standards and quality as specified in Article 4.
- The Medical Infrastructure and Equipment Department shall be responsible for implementing this Circular (Article 8).
- The owner of medical devices is responsible for documentation proving compliance with technical standards and quality requirements as stipulated in Articles 2, 3, and 4.
🌐 이 문서의 사회적 영향
- Strengthen management of imported medical device quality into Vietnam.
- Ensure competitive bidding in selecting contractors to supply medical devices for user units.
- Facilitate healthcare facilities in identifying and purchasing medical devices that meet their professional needs.
- It may impose financial and time burdens on manufacturers or importers of medical devices when they have to prove compliance with technical standards and quality.
❓ 자주 묻는 질문
What standards must medical devices meet to be classified?
Medical devices must comply with technical standards as prescribed in Article 2 and have lawful circulation certification in one or more countries, territories chosen by the user unit.
Which organizations are authorized to confirm the quality of medical devices?
Organizations such as the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), or similar agencies in EU member states.
When does this Circular take effect?
Circular No. 57/2025/TT-BYT takes effect from February 15, 2026.
전문
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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No.: 57/2025/TT-BYT |
Hanoi, December 31, 2025 |
CIRCULAR
GUIDELINES ON CLASSIFICATION OF MEDICAL DEVICES BASED ON TECHNICAL STANDARDS AND QUALITY
Pursuant to Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical device management, which has been amended and supplemented by Decree No. 07/2023/NĐ-CP;
Pursuant to Decree No. 214/2025/NĐ-CP dated August 4, 2025 of the Government detailing certain provisions and measures for implementing the Law on Public Procurement regarding contractor selection;
Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Medical Infrastructure and Equipment Department,
The Minister of Health issues this Circular guiding the classification of medical devices based on technical standards and quality.
Article 1. Scope of Regulation
This Circular guides the classification of medical devices based on technical standards and quality as prescribed in Point d Clause 2 Article 146 of Decree No. 214/2025/NĐ-CP dated August 4, 2025 of the Government detailing certain provisions and measures for implementing the Law on Public Procurement regarding contractor selection.
Article 2. Basis for Determining Technical Standards and Quality
1. The technical standards of medical devices shall be determined based on the provisions of Vietnamese laws on standards and technical regulations when meeting one or more of the following criteria:
a) National standards.
b) International standards.
c) Regional standards.
d) Foreign standards.
đ) Enterprise standards.
2. Forms of determining compliance with technical standards of medical devices as prescribed in Clause 1 of this Article:
a) Certification of conformity in accordance with the provisions of Vietnamese laws on standards and technical regulations.
b) Results of conformity assessment by one of the following organizations:
- International conformity assessment organization;
- Domestic or foreign conformity assessment organization established and operating legally in Vietnam.
c) Documentation provided by the owner of the medical device proving that the medical device meets the technical standards required by the user unit.
3. The quality of medical devices shall be determined based on whether the medical devices have been permitted to circulate in one or several countries or territories.
Article 3. Principles for Classifying Medical Devices Based on Technical Standards and Quality
1. Medical devices must meet both technical standards and quality requirements according to professional requirements and needs of the user units corresponding to the groups specified in Article 4 of this Circular and be legally circulating in Vietnam.
2. Medical devices manufactured in Vietnam may participate in all groups specified in Article 4 of this Circular if they simultaneously meet the following conditions:
a) Regarding technical standards: Meeting the technical standard requirements of the medical devices selected by the user units corresponding to the groups as stipulated in Article 4 of this Circular.
b) Regarding quality: Legally circulating in Vietnam.
Article 4. Guidelines for Classifying Medical Devices Based on Technical Standards and Quality
1. Group 1:
a) Regarding technical standards: Medical devices have one or more specific technical standards selected by the user units and comply with the provisions of Clause 1 of Article 2 and Point a Clause 2 of this Circular.
b) Regarding quality: Medical devices have at least one organization, country, or territory permitting circulation in the corresponding country or territory selected by the user units from the list attached to this Circular.
2. Group 2:
a) Regarding technical standards: Medical devices have one or more specific technical standards selected by the user units and comply with the provisions of Clause 1 of Article 2 and Point a Clause 2 of this Circular.
b) Regarding quality: Medical devices have at least one organization, country, or territory permitting circulation in the corresponding country or territory selected by the user units outside the list attached to this Circular.
3. Group 3:
a) Regarding technical standards: Medical devices have one or more specific technical standards selected by the user units and comply with the provisions of Clause 1 of Article 2 and Point a or b Clause 2 of this Circular.
b) Regarding quality: Medical devices have at least one organization, country, or territory permitting circulation in the corresponding country or territory selected by the user units from the list attached to this Circular.
4. Group 4:
a) Regarding technical standards: Medical devices have one or more specific technical standards selected by the user units and comply with the provisions of Clause 1 of Article 2 and Point a or b Clause 2 of this Circular.
b) Regarding quality: Medical devices have at least one organization, country, or territory permitting circulation in the corresponding country or territory selected by the user units outside the list attached to this Circular.
5. Group 5:
a) Regarding technical standards: Medical devices have one or more specific technical standards selected by the user units and comply with the provisions of Clause 1 of Article 2 and Point a or b or c Clause 2 of this Circular.
b) Regarding quality: Medical devices have at least one organization, country, or territory permitting circulation in the corresponding country or territory selected by the user units from the list attached to this Circular.
6. Group 6:
a) Regarding technical standards: Medical devices have one or more specific technical standards selected by the user units and comply with the provisions of Clause 1 of Article 2 and Point a or b or c Clause 2 of this Circular.
b) Regarding quality: Medical devices have at least one organization, country, or territory permitting circulation in the corresponding country or territory selected by the user units outside the list attached to this Circular.
Article 5. Effective Date
This Circular takes effect from February 15, 2026.
Article 6. Implementation Schedule
1. Relevant units and organizations shall be responsible for preparing necessary conditions to implement this Circular from the date it takes effect.
2. The classification of medical devices according to technical standards and quality criteria shall be carried out from January 1, 2027.
Article 7. Reference Provisions
In case the referenced documents in this Circular are replaced or amended, implementation shall be in accordance with the replacing or amending documents.
Article 8. Organization of Implementation
1. The Medical Equipment Infrastructure Department shall be responsible for: Taking the lead and coordinating with relevant agencies and units to implement this Circular.
2. The head of the unit responsible for classifying medical devices according to technical standards and quality criteria shall be responsible for:
a) Deciding on the classification of medical devices according to technical standards and quality criteria that are suitable for management requirements, usage needs, and the demands of the using entity.
b) Organizing the classification according to technical standards and quality criteria must ensure competition within each group, fairness, transparency, efficiency, and accountability as prescribed by law.
3. The owner of the circulation number of medical devices shall be responsible for providing documentation proving that the medical devices meet the technical standards and quality criteria as stipulated in Articles 2, 3, and 4 of this Circular.
During the implementation process, if there are difficulties or obstacles, organizations and individuals shall report them to the Ministry of Health (Medical Equipment Infrastructure Department) for consideration and resolution.
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Place of Receipt: |
DEPUTY MINISTER
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ANNEX
(Annexed to Circular No. 57/2025/TT-BYT dated December 31, 2025 of the Minister of Health guiding the classification of medical devices according to technical standards and quality criteria)
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Serial number |
Referenced Countries and Organizations |
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1 |
U.S. Food and Drug Administration (FDA) - United States; |
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2 |
Therapeutic Goods Administration (TGA) - Australia |
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3 |
Health Canada - Canada; |
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4 |
Japanese Ministry of Health, Labour and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) - Japan, |
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5 |
European Union Member States |
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6 |
United Kingdom |
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7 |
Switzerland |
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8 |
China National Medical Products Administration (NMPA); |
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9 |
South Korea Ministry of Food and Drug Safety (MFDS) or National Institute of Medical Device Safety Information (NIDS). |
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