Feb 18, 2022

The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device regulatory authority, plans on making partial updates to its medical device manufacturing license renewal law no. 18446.

MFDS plans partial revision to renewal rules for medical device manufacturing licenses

Medical device manufacturers in the South Korean market should take note of the MFDS plans to change the requirements for the renewal of medical device manufacturing licenses. The revised rules that were announced (link in Korean) affect two sections of the Medical Devices Act.

First, MFDS announced the amendment to the by-laws for medical device manufacturers that have applied for manufacturing licenses prior to October 8, 2020. The changes have been made to streamline the data submission process for medical device manufacturers who have submitted data for a previous license and for which that data remains unchanged. If you are a medical device manufacturer and can confirm that there is production and income reported in the medical device supply history report supplied for the previous licensing period to the MFDS, you are exempt from having to resubmit the same information again with your license renewal application.

Second, if you are a medical device manufacturer with a license that was issued before October 8, 2020, you should be aware that, according to the amendment to article 2 of the Medical Devices Act, the expiration date for medical device manufacturing licenses for products retested in accordance with article 8 will be determined by the MFDS from January 1, 2025 to December 31, 2030.

Additional South Korean medical device regulatory resources:

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    Kathryn Burke

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