On December 31, 2025, the Minister of Health issued Circular No. 57/2025/TT-BYT, providing guidance on the classification of medical devices by technical and quality standards pursuant to Point (d), Clause 2, Article 146 of Government Decree No. 214/2025/NĐ-CP, which details the implementation of the Law on Bidding with respect to contractor selection.
The Circular establishes criteria for categorizing medical devices into designated groups based on technical specifications, quality standards, and circulation authorization requirements.
Read the full circular here: See attached document [PDF]
Purpose of the Circular
- To provide guidance on the categorization of medical devices by technical and quality criteria.
- To ensure consistency in device classification for procurement under Vietnam’s bidding law.
- To outline reference standards and recognized authorities applicable to medical device assessments.
Scope of Application
The Circular applies to medical devices falling within designated groups, which must:
- Meet technical and quality standards defined by the procuring or user unit.
- Align with professional requirements and practical needs.
- Be authorized for circulation in Vietnam.
Medical devices manufactured domestically may be classified into any group if they satisfy the required technical and quality criteria.
Key Highlights
Criteria for Domestic Devices
- Technical Standards: Devices must meet the technical requirements specified by the user unit for each group.
- Quality Standards: Devices must be legally authorized for circulation in Vietnam.
Recognized International Reference Authorities
The Circular identifies the following organizations, countries, and territories as reference standards:
- United States: Food and Drug Administration (FDA)
- Australia: Therapeutic Goods Administration (TGA)
- Canada: Health Canada
- Japan: MHLW / PMDA
- Member States of the European Union
- United Kingdom
- Switzerland
- China: National Medical Products Administration (NMPA)
- South Korea: MFDS / NIDS
Medical Device Categorization Framework
Medical devices are classified into six groups based on technical and quality requirements:
Group 1
- Technical Standards: Must comply with standards selected by the user unit in accordance with Clause 1, Article 2, and Point (a), Clause 2, Article 2 of the Circular
- Quality: Must be authorized for circulation by at least one of the organizations, countries, or territories listed as reference standards, as determined by the user unit.
Group 2
- Technical Standards: Same as Group 1.
- Quality: Must be authorized for circulation in at least one country or territory not included in the reference list.
Group 3
- Technical Standards: Must meet requirements similar to Group 1, with additional provisions from Point (b), Clause 2, Article 2.
- Quality: Same as Group 1.
Group 4
- Technical Standards: Same as Group 3.
- Quality: Same as Group 2.
Group 5
- Technical Standards: Must meet Group 3 requirements with additional provisions from Point (c), Clause 2, Article 2.
- Quality: Same as Group 1.
Group 6
- Technical Standards: Same as Group 5.
- Quality: Same as Group 2.
Implications to Clients
Clients are encouraged to review and understand the technical and quality criteria for medical device classification as outlined in Circular No. 57/2025/TT-BYT. Proper categorization is essential for compliance in bidding and procurement activities in Vietnam.
Effective Dates
- Circular effective date: 15 February 2026
- Implementation of categorization regulations: 1 January 2027
For Inquiries
For inquiries or support regarding regulatory requirements for medical devices in Vietnam, please contact sales@andamanmed.com.
