China's New Medical Device Regulations Bring Big Changes

Law360 (July 23, 2018, 2:19 PM EDT) -- The People's Republic of China Ministry of Justice recently published a comprehensive draft amendment outlining the proposed revisions to the current Medical Device Regulations, previously known as the State Council Order # 650. The draft amendment is now ready for public comments until July 24, 2018.

This draft amendment updated a previous draft amendment[1] (“2017 draft”) issued by the former China Food and Drug Administration last October. Several regulatory reform initiatives announced by China’s State Council were formally included in the draft amendment, e.g. compassionate use (or expanded access) of devices that treat life-threatening diseases without any effective cures, and conditional...

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