Vietnam’s Detailed Regulations on the Implementation of Decree No. 98/2021/ND-CP on Medical Device Management

The Ministry of Health of Vietnam issued Circular No. 05/2022/TT-BYT dated August 1, 2022, providing detailed regulations for the implementation of certain provisions of Decree No. 98/2021/ND-CP on the Management of Medical Devices. The Circular took effect on the same date and serves as an important regulatory document for organizations and individuals involved in the medical device sector in Vietnam.

The Circular provides detailed guidance on several key areas of medical device management, particularly medical device classification, a critical regulatory step that determines the applicable management requirements based on the risk level of each device. It also provides guidance on the responsibilities and procedures applicable to organizations involved in the classification of medical devices.

In addition, the Circular addresses requirements concerning the registration and recognition of organizations eligible to conduct medical device classification, as well as other regulatory procedures associated with the management of medical devices under Decree No. 98/2021/ND-CP.

For manufacturers, importers, distributors, and international companies seeking to place medical devices on the Vietnamese market, understanding these detailed requirements is important for ensuring regulatory compliance and preparing the appropriate documentation and procedures.

The regulatory framework established by Circular No. 05/2022/TT-BYT has subsequently been updated through amendments and supplementary regulations. In particular, Circular No. 59/2025/TT-BYT amended and supplemented certain provisions of Circular No. 05/2022/TT-BYT, while Circular No. 24/2026/TT-BYT, effective from July 1, 2026, further amended the framework and introduced regulations concerning the determination of risk levels and management measures applicable to products and goods classified as medical devices.

The updated regulatory framework provides an important reference for stakeholders seeking to understand Vietnam’s medical device classification and management requirements. Labomed Vietnam provides the detailed legal document and related information to support manufacturers, suppliers, distributors, and international partners in navigating Vietnam’s medical device regulatory environment.