Classify medical devices into 6 groups
According to the Ministry of Health , the purpose of grouping is to develop regulations and legal corridors in principle to help units identify groups of medical equipment with desired technical standards and quality, suitable for their professional needs and financial capacity. At the same time, it creates a basis for investors to proactively choose medical equipment with advanced and modern technical standards and quality.
Draft Circular providing guidance on classifying medical equipment according to technical and quality standards specified in Point d, Clause 2, Article 146 of Decree No. 214/2025/ND-CP dated August 4, 2025 of the Government detailing a number of articles and measures to implement the Law on Bidding on contractor selection.
Guidelines on the basis, principles and classification of medical equipment according to technical and quality standards.
Principles of classifying medical equipment according to technical and quality standards
Medical equipment must be classified according to technical and quality standards according to professional requirements and the needs of the using unit.
Medical equipment manufactured in Vietnam is eligible to participate in the corresponding group selected by the user if it simultaneously meets the following conditions:
Regarding technical standards: Meet the technical standard requirements of medical equipment selected by the using unit corresponding to the group according to regulations.
About quality: Legally circulated in Vietnam.
Classify medical equipment according to technical and quality standards
The draft clearly classifies medical equipment according to technical and quality standards into 6 groups:
Group 1:
a) Regarding technical standards: There is one or several specific technical standards selected by the using unit that meet the provisions in Clause 1, Article 2 and Point a, Clause 2, Article 2 of this Circular (According to Point a, Clause 2, Article 2: Certification of conformity according to the provisions of Vietnamese law on technical standards and regulations).
b) Regarding quality: There must be at least 01 organization, country or territory that allows circulation in the corresponding country or territory selected by the using unit from the list specified in the Appendix issued with this Circular.
Clause 1, Article 2 of the draft clearly states:
Technical standards of medical equipment are determined based on the provisions of Vietnamese law on technical standards and regulations, when meeting one or more of the following standards:
a) National standards.
b) International standards.
c) Regional standards.
d) Foreign standards.
d) Basic standards.
Group 2:
Regarding technical standards: There is one or several specific technical standards selected by the using unit that meet the provisions in Clause 1, Article 2 and Point a, Clause 2, Article 2 of this Circular.
Regarding quality: There must be at least 01 organization, country or territory that allows circulation in the corresponding country or territory selected by the using unit outside the list specified in the Appendix issued with this Circular.
Group 3:
Regarding technical standards: There is one or several specific technical standards selected by the using unit that meet the provisions in Clause 1, Article 2 and Point a or b, Clause 2, Article 2 of this Circular.
Regarding quality: There must be at least 01 organization, country or territory that allows circulation in the corresponding country or territory selected by the using unit from the list specified in the Appendix issued with this Circular.
Group 4:
Regarding technical standards: There is one or several specific technical standards selected by the using unit that meet the provisions in Clause 1, Article 2 and Point a or b, Clause 2, Article 2 of this Circular.
Regarding quality: There must be at least 01 organization, country or territory that allows circulation in the corresponding country or territory selected by the using unit outside the list specified in the Appendix issued with this Circular.
Group 5:
Regarding technical standards: There is one or several specific technical standards selected by the using unit that meet the provisions in Clause 1, Article 2 and Point a or b or c, Clause 2, Article 2 of this Circular.
Regarding quality: There must be at least 01 organization, country or territory that allows circulation in the corresponding country or territory selected by the using unit from the list specified in the Appendix issued with this Circular.
Group 6:
Regarding technical standards: There is one or several specific technical standards selected by the using unit that meet the provisions in Clause 1, Article 2 and Point a or b or c, Clause 2, Article 2 of this Circular.
Regarding quality: There must be at least 01 organization, country or territory that allows circulation in the corresponding country or territory selected by the using unit outside the list specified in the Appendix issued with this Circular.
The Ministry of Health is seeking comments on this draft on the Ministry's Information Portal.
Minh Hien
Source: https://baochinhphu.vn/de-xuat-huong-dan-ve-phan-nhom-thiet-bi-y-te-theo-tieu-chuan-ky-thuat-chat-luong-102251128125312099.htm
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