Post-Market — Overview and Ongoing Obligations
Once a medical device is on the Korean market, manufacturers and importers have ongoing regulatory obligations for the life of the product.
Core obligations
Adverse event reporting — Manufacturers and importers must report serious or unexpected adverse events within 15 calendar days, and other adverse events or malfunctions within 30 calendar days to MFDS
MFDS active post-market role
MFDS runs its own market surveillance inspections, monitors adverse event databases, orders device testing from the market, and initiates re-evaluations based on international safety signals.