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In Brief: Vietnamese Ministry of Health Proposes New Decree for Medical Device Regulation

The Vietnamese Ministry of Health published a draft decree meant to consolidate and expand the country's regulatory framework for medical devices.

Vietnamese Ministry of Health proposes new decree for medical device regulation

April 21, 2021

The Vietnamese Ministry of Health (MoH) published a draft decree (download link, in Vietnamese) intended to replace Decree No. 36/2016/ND-CP​ and its amendments, which form the legal framework for regulating medical devices in Vietnam. The draft, released as Official Dispatch No. 2271/BYT-TB-CT, consolidates the amendments made to the current decree and introduces new sections addressing clinical trials, Essential Principles for Safety and Efficiency of Medical Devices, and advertising.

Notably, the draft proposes to expand the scope of devices eligible for fast-track approval to include those that have registrations in only one reference market, as well as devices used in emergencies, epidemics, and natural disasters. It also proposes to increase the ​MoH's timelines for reviewing documents to determine the feasibility of the process.

​​​Further resources for medical device and IVD registration in Southeast Asia from Emergo by UL: