Regulations regarding the reevaluation of medical devices by the MFDS are expected to be partially revised.

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Regulations regarding the reevaluation of medical devices by the MFDS are expected to be partially revised. Public comments will be accepted until January 17, 2024.


- To swiftly overcome public health crises, improvements have been made to exclude products designated as public health crisis response medical devices from reevaluation.


- Even in cases where there are domestically available alternative medical devices, improvements have been made to exclude products from reevaluation if they are deemed essential for stable public health supply support.





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Email: forest.lee@gca-kr.com

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