Starting from last February and until July 22, 2016, the MFDS (Ministry of Food and Drug Safety), in cooperation with MOHW (Ministry of Health and Welfare) opened a new program called Integrated Service for Medical Device Approval and Health Technology Assessment (HTA) to the companies.

Aim of the new program is to combine the medical device approval procedure with the sanitary technology assessment in terms of safety and effectiveness of innovative devices.

Companies adhering to the program will receive a unique final response for both aspects (marketing approval and innovative technology assessment) by 120 days from the application request to MFDS.


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