On December 31, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 57/2025/TT-BYT providing guidance on the classification of medical devices according to technical standards and quality requirements (Circular 57), applicable to procurement activities for medical devices in Vietnam.
According to the MOH, the purpose of the classification is to establish a principle-based legal framework and regulations that enable purchasers to easily identify groups of medical devices aligned with their professional requirements and financial capacity.
Some of the key stipulations of Circular 57 are outlined below.
Basis for Determining Technical Standards and Quality
Under Circular 57, the technical standards of medical devices are determined in accordance with Vietnamese laws on standards and technical regulations, through the following means:
- Certification of conformity with standards in accordance with Vietnamese laws on standards and technical regulations;
- Results of conformity assessment conducted by an internationally recognized conformity assessment organization or a legally established domestic or foreign conformity assessment organization operating in Vietnam; and
- Documentation evidencing compliance provided by the medical device owner.
The quality of medical devices is determined based on whether the device has been approved for circulation by the relevant marketing authority of one or more jurisdictions.
Classification of Medical Devices
Circular 57 classifies medical devices into six groups (from Group 1 to Group 6) based on technical standards and quality.
Medical devices subject to classification must simultaneously meet technical standards and quality requirements in accordance with professional specifications and user needs, and must be lawfully marketed in Vietnam.
Medical devices manufactured in Vietnam may participate in all corresponding groups, provided they meet the technical standards required by the user and are lawfully marketed in Vietnam.
Outlook
Circular No. 57 will take effect on February 15, 2026, while the classification requirements will become effective on January 1, 2027.
Holders of medical device registration numbers are advised to proactively prepare documentation demonstrating compliance with technical standards and quality requirements to facilitate the classification process.
