Post-Market Clinical Follow-Up (PMCF)
MFDS may require a PMCF study as a condition of a Grade III or IV ํ๋ชฉํ๊ฐ 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 ํ๋ชฉํ๊ฐ 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.