123 Medical Products Approved in South Korea in May 2025

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South Korea’s Ministry of Food and Drug Safety (MFDS) approved 123 medical products in May 2025, representing 99.2% of the 2024 monthly average (124 products) and 111.8% of the Q1 2025 average (110 products).

 

The breakdown is:

  • 37 pharmaceuticals
  • 2 quasi-drugs
  • 84 medical devices

 

In addition, the MFDS approved “Cogthera,” the first domestic digital medical device to help delay cognitive decline in patients with mild cognitive impairment.

 

Ensure compliance with Korean medical device regulations.
 GCA KOREA provides tailored guidance and reliable certification support for your product.


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