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, importers 15 calendar days (serious/unexpected adverse events) or 30 calendar days (other adverse events/malfunctions)
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.