Korea to align medical device regulations with international standards

South Korea’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS) is drafting plans to better sync its quality control requirements for medical devices with international standards.

In proposing to align Korea Good Manufacturing Practice (KGMP) quality system regulations to the International Organization for Standardization (ISO) standard 13485:2016, South Korea is seeking to ensure compliance with universal quality standards for the design, manufacture, export and sales of various medical devices. Adopting the new standard would also smooth Korea’s participation in the International Medical Device Single Audit Program, facilitating speedier approvals of devices in the future.

MFDS will accept industry comment on the draft plan through the end of November.