South Korea's MFDS Revision of Medical Device Manufacturing and Quality Control Standards

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical device manufacturing and quality control standards". This notification will take effect from 1 July 2019.

This revision is a reflection of South Korea's MFDS effort to harmonize with the international standards of medical device Good Manufacturing Practice (GMP). This includes improvements to the GMP system by eliminating the blind spots of quality control, such as the addition of data submitted by the manufacturing facility, and aligning the KGMP to ISO 13485:2016 from the previous ISO 13485:2003.


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