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Post-Market Clinical Follow-Up (PMCF)

MFDS may require a PMCF study as a condition of a Grade III or IV 품목허가 when:

  • The device is a first-in-class technology
  • Clinical data at approval was limited
  • A specific safety concern needs monitoring

Requirements​

  • A PMCF protocol approved as part of or after the 품목허가 application
  • Study design adequate to address identified questions (registry, case series, prospective)
  • Results reported to MFDS within the agreed timeframe

Integration with PMS​

PMCF data forms part of the ongoing PMS and feeds into the re-examination dossier.

Results reported to MFDS within the agreed timeframe​

"Responsibility lies with the 품목허가 holder (manufacturer or importer). Failure to submit results on time may result in suspension or revocation of the 품목허가 or enforcement action."