Skip to main content

Post-Market Clinical Follow-Up (PMCF)

MFDS may require a PMCF study as a condition of a Grade III or IV ํ’ˆ๋ชฉํ—ˆ๊ฐ€ when:

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

Requirementsโ€‹

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

Integration with PMSโ€‹

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

Results reported to MFDS within the agreed timeframeโ€‹

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