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

Obligation	Who	Key detail
Adverse event reporting	Manufacturers, importers	15-day (serious) or 30-day (malfunction)
Post-market surveillance (PMS)	Grade III/IV holders	PMS plan and periodic reports
Re-examination (재심사)	Grade III/IV holders	Required 3–5 years post-approval for new devices
Re-evaluation (재평가)	All — triggered by MFDS	Based on new safety signals
Recalls / FSCA	All	Mandatory when device is defective or unsafe
Korean-language labelling	All	Labels must remain compliant
UDI-K / KIMS maintenance	All	Keep KIMS records current
Business licence maintenance	All	Keep manufacturer/importer licence active
GMP certificate maintenance	All	Keep KGMP / foreign GMP certificate valid

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.

Related pages

• Adverse event reporting · Re-examination · Recalls and FSCA