Ministry of Health (Vietnam) has released a draft decree that would replace Decree No. 36/2016/ND-CP and its revisions. This established the country's regulatory framework for medical devices.
The proposal named Official Dispatch No. 2271/BYT-TB-CT merges with the present decree's revisions and adds new sections on clinical trials, Essential Principles for Safety and Efficiency and promoting.
In addition, the draft proposes to broaden the spectrum of devices eligible for fast-track clearance to include those with only one reference market registration and devices that are required in emergency situation. The draft also suggest for MoH to extend the document review timelines in order to assure the process's viability.
Sources:
No. 36/2016/ND-CP
Official Dispatch No. 2271/BYT-TB-CT
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