Import Bans and Market Withdrawal Orders
Import bansโ
MFDS may issue an import ban for specific products or from specific foreign manufacturers when:
- A device poses an unacceptable safety risk to Korean patients
- The foreign manufacturer's GMP has been found seriously deficient
- The product has been subject to a significant recall or withdrawal in another major jurisdiction
- The product fails to meet labelling or compliance requirements for the Korean market
Market withdrawal ordersโ
MFDS may order the withdrawal from the Korean market of all units of a specific product when:
- A Class 1 recall is required but the manufacturer/importer has not acted
- The device is found to be genuinely unsafe based on post-market data
- The ํ๋ชฉํ๊ฐ is cancelled by MFDS
Notification of import bansโ
MFDS publishes import ban decisions on its website. Importers and distributors must check the MFDS notification list before importing.