Circular 57/2025/TT-BYT guiding the classification of medical equipment by technical standards and quality

CIRCULAR

Guiding the classification of medical equipment by technical standards and quality

Pursuant to the Government’s Decree No. 98/2021/ND-CP of November 08, 2021, on management of medical equipment, amended and supplemented under Decree No. 07/2023/ND-CP;

Pursuant to the Government’s Decree No. 214/2025/ND-CP dated August 04, 2025, detailing a number of articles of and measures to implement the Bidding Law regarding contractor selection;

Pursuant to the Government's Decree No. 42/2025/ND-CP dated February 27, 2025, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Agency for Health Infrastructure and Medical Equipment,

The Minister of Health hereby promulgates the Circular guiding the classification of medical equipment by technical standards and quality.

Article 1. Scope of regulation

This Circular provides guidelines on classification of medical equipment by technical standards and quality as prescribed at Point d, Clause 2, Article 146 of the Government’s Decree No. 214/2025/ND-CP dated August 04, 2025 detailing a number of articles of, and measures to implement, the Bidding Law regarding contractor selection.

Article 2. Bases for determination of technical standards and quality

1. Technical standards applicable to medical equipment shall be determined in accordance with Vietnamese laws on standards and technical regulations, when meeting one or more of the following standards:

a) National standards.

b) International standards.

c) Regional standards.

d) Foreign standards.

dd) In-house standards.

2. Forms of determination of compliance with technical standards of medical equipment prescribed in Clause 1 of this Article include:

a) Certification of conformity in accordance with Vietnamese laws on standards and technical regulations.

b) Results of conformity assessment by any of the following organizations:

- International conformity assessment organizations;

- Domestic or foreign conformity assessment organizations lawfully established and operating in Vietnam.

c) Documents provided by the medical equipment owner evidencing that such medical equipment meets the technical standards as required by the user.

3. Quality of medical equipment shall be determined based on whether the medical equipment has been permitted for circulation in one or more countries or territories.

Article 3. Principles for classification of medical equipment by technical standards and quality

1. Medical equipment subject to classification must concurrently satisfy technical standards and quality in accordance with professional requirements and the needs of the user corresponding to the group prescribed in Article 4 of this Circular, and must be lawfully circulated in Vietnam.

2. Medical equipment manufactured in Vietnam may participate in all corresponding groups prescribed in Article 4 of this Circular if it concurrently satisfies the following conditions:

a) In terms of technical standards: Meeting the technical standard requirements of the medical equipment selected by the user corresponding to the group as prescribed in Article 4 of this Circular.

b) In terms of quality: Being lawfully circulated in Vietnam.

Article 4. Guidelines on classification of medical equipment by technical standards and quality

1. Group 1:

a) In terms of technical standards: Medical equipment of which one or more specific technical standards selected by the user, satisfy the provisions of Clause 1, Article 2 and Point a, Clause 2, Article 2 of this Circular.

b) In terms of quality: Medical equipment is permitted by at least one organization, country, or territory for circulation in the corresponding country or territory selected by the user within the list prescribed in the Appendix to this Circular.

2. Group 2:

a) In terms of technical standards: Medical equipment of which one or more specific technical standards selected by the user, satisfy the provisions of Clause 1, Article 2 and Point a, Clause 2, Article 2 of this Circular.

b) In terms of quality: Medical equipment is permitted by at least one organization, country, or territory for circulation in the corresponding country or territory selected by the user outside the list prescribed in the Appendix to this Circular.

3. Group 3:

a) In terms of technical standards: Medical equipment of which one or more specific technical standards selected by the user, satisfy the provisions of Clause 1, Article 2 and Point a or Point b, Clause 2, Article 2 of this Circular.

b) In terms of quality: Medical equipment permitted by at least one organization, country, or territory for circulation in the corresponding country or territory selected by the user within the list prescribed in the Appendix to this Circular.

4. Group 4:

a) In terms of technical standards: Medical equipment of which one or more specific technical standards selected by the user, satisfy the provisions of Clause 1, Article 2 and Point a or Point b, Clause 2, Article 2 of this Circular.

b) In terms of quality: Medical equipment is permitted by at least one organization, country, or territory for circulation in the corresponding country or territory selected by the user outside the list prescribed in the Appendix to this Circular.

5. Group 5:

a) In terms of technical standards: Medical equipment of which one or more specific technical standards selected by the user, satisfy the provisions of Clause 1, Article 2 and Point a or Point b or Point c, Clause 2, Article 2 of this Circular.

b) In terms of quality: Medical equipment permitted by at least one organization, country, or territory for circulation in the corresponding country or territory selected by the user within the list prescribed in the Appendix to this Circular.

6. Group 6:

a) In terms of technical standards: Medical equipment of which one or more specific technical standards selected by the user, satisfy the provisions of Clause 1, Article 2 and Point a or Point b or Point c, Clause 2, Article 2 of this Circular.

b) In terms of quality: Medical equipment is permitted by at least one organization, country, or territory for circulation in the corresponding country or territory selected by the user outside the list prescribed in the Appendix to this Circular.

Article 5. Effect

This Circular takes effect from February 15, 2026.

Article 6. Roadmap for implementation

1. Relevant units and organizations shall prepare conditions necessary for the implementation from the effective date of this Circular.

2. The classification of medical equipment by technical standards or quality shall be applied from July 01, 2027.

Article 7. Reference provisions

In case any documents referred to in this Circular are amended, supplemented or replaced, the new ones shall prevail.

Article 8. Implementation organization

1. The Agency for Health Infrastructure and Medical Equipment shall: Assume the prime responsibility for, and coordinate with relevant agencies and units in, implementing this Circular.

2. Heads of units in charge of medical equipment classification by technical standards or quality shall:

a) Decide on the classification of medical equipment by technical standards and quality in conformity with management requirements, use requirements, and the needs of the user.

b) Organize the implementation of classification by technical standards and quality in a manner ensuring competition within each group, fairness, transparency, effectiveness, and accountability in accordance with law.

3. Holders of medical equipment's circulation numbers shall be responsible for documents evidencing that medical equipment satisfies the requirements on technical standards and quality in accordance with Articles 2, 3, and 4 of this Circular.

Any difficulties arising in the course of implementation shall be reported to the Ministry of Health (the Agency for Health Infrastructure and Medical Equipment) for consideration and settlement./.