Vietnam Issues Circular No. 44/2025/TT-BYT on Decentralization of Medical Device Regulatory Procedures

The Ministry of Health of Vietnam has issued Circular No. 44/2025/TT-BYT dated November 22, 2025, providing for the decentralization of certain regulatory tasks and administrative procedures in the medical device sector under the authority of the Ministry of Health. The Circular also introduces new templates for documents and reports used in the management of medical devices.

The Circular is issued pursuant to the Law on Government Organization No. 63/2025/QH15 and relevant regulations, including Decree No. 98/2021/ND-CP on the Management of Medical Devices, as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP, and Decree No. 04/2025/ND-CP. It also takes into account Decree No. 217/2025/ND-CP on specialized inspection activities and Decree No. 42/2025/ND-CP defining the functions, duties, powers, and organizational structure of the Ministry of Health.

Under the new framework, a number of medical device regulatory responsibilities are decentralized to the Department of Medical Infrastructure and Devices, including the issuance of new marketing authorization numbers for Class C and D medical devices, post-market inspections, suspension and recall of medical device batches, and revocation of marketing authorization numbers.

The Department is also responsible for issuing import licenses and Certificates of Free Sale (CFS), handling the registration of medical device inspection organizations, and deciding on the handling of medical devices that fail inspection requirements. In addition, it will conduct specialized inspections covering organizations and individuals involved in medical device classification, manufacturing, circulation, trading, import and export, service provision, information and advertising, as well as the management and use of medical devices at healthcare facilities.

The Circular takes effect from November 22, 2025, replacing Circular No. 19/2021/TT-BYT, as amended by Circular No. 10/2023/TT-BYT, regarding forms and reports for the implementation of Decree No. 98/2021/ND-CP. Existing valid authorization letters and warranty eligibility certificates issued under the previous forms may continue to be used in accordance with the transitional provisions.

For manufacturers, importers, distributors, and international medical device companies operating in Vietnam, the Circular provides an updated reference framework for understanding regulatory responsibilities, administrative procedures, required documentation, and compliance requirements in the medical device market.