Government apply negative regulations on approval of IVDs

Published: 2018-03-21 16:28:35

Updated: 2018-03-21 16:28:56

The ‘In Vitro Diagnostics(IVDs) Act’ will be separately legislated from the Medical Device Law, and negative regulations will be applied in applying approval for IVDs.

The Ministry of Food and Drug Safety(MFDS) announced that they were carrying out legislation of the ‘In Vitro Diagnostics Act’ containing articles to improve the approval and control system based on special characteristics of IV...

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