Explore the medical device requirements currently available for South Korea, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
5 years for covered medical-device permits/certifications/notifications, except stated exemptions.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Failure to renew causes the authorization to lapse.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Apply 270-180 days before expiry with safety/effectiveness and production/import history.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Licensed Importer As Applicant
Korean licensed importer/product authorization holder
yes
Foreign Device Enters Through Licensed Importer
Same Core Local Role
May Be Separate
Allowed Subject To Business Licences
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
