Decree No. 98/2021/ND-CP on the Management of Medical Devices

On November 8, 2021, the Government of Vietnam issued Decree No. 98/2021/ND-CP on the Management of Medical Devices, establishing an important legal framework for the manufacture, trading, importation, and use of medical devices in Vietnam. The Decree officially took effect on January 1, 2022, and has since been amended and supplemented by relevant legal instruments.

The Decree provides a comprehensive regulatory framework covering various aspects of medical device management, including classification by risk level; manufacturing; clinical research; circulation; trading; export and import; provision of medical device-related services; information and advertising; price management; inspection and calibration; and the management and use of medical devices at healthcare facilities.

One of the key provisions is the risk-based classification of medical devices into four categories: A, B, C, and D, corresponding to different levels of potential risk. The Decree also establishes requirements concerning marketing authorization numbers, declaration of applicable standards, registration of medical devices, as well as cases eligible for exemption from or emergency issuance of marketing authorization numbers. It further sets out the responsibilities of marketing authorization holders and other relevant organizations and individuals.

In addition, the Decree introduces requirements relating to the declaration and publication of medical device prices, inspection and calibration, business conditions, advertising, record management, and the implementation of administrative procedures through electronic systems. These provisions directly affect manufacturers, importers, distributors, and service providers operating in Vietnam’s medical device sector.

Decree No. 98/2021/ND-CP has been amended and supplemented to further improve the regulatory framework governing medical devices in Vietnam. Labomed Vietnam presents the full text and related information to provide manufacturers, suppliers, distributors, healthcare organizations, and international partners with a convenient reference source when operating in or exploring opportunities in Vietnam’s medical device market.