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품목신고 — Processing Timelines

After successful 품목신고​

  1. MFDS issues a 품목신고증 (Product Notification Certificate)
  2. Product may be marketed in Korea
  3. Register the product in KIMS (UDI-K database)
  4. Apply Korean-language labelling before commercial supply

Ongoing obligations​

Even after notification, the holder must:

  • Maintain active business licence and GMP certificate
  • Report adverse events
  • Notify MFDS of changes via 변경신고
  • Comply with all post-market obligations