REGULATORY AUTHORITY: Ministry of Food and Drug Safety (MFDS)
CLASSIFICATION SYSTEM: Medical Devices and IVDs: I/II/III/IV
Medical Devices and IVDs:
- Class I (Notification)– Immediately
- Class II/III/IV (Product Certification) – 5 working days
- Class II/III/IV (Product Approval) – 10 working day
Technical Document Review – 55 working days
Clinical Investigation Data Review – 70 working days
KGMP Certification – 10-15 working days (on-site inspection); 30 days (document inspection)
Timeline Based on Experience:
Technical Document Review – approx. 3 months
Clinical Investigation Data Review – approx. 3 months
KGMP Certification – approx. 1 month
LOCAL FEES (New Application):
KGMP Certification – varies according to the audit institution.
Product Notification – USD 32
Product Certification/Approval (without technical review) – USD 142
Product Certification/Approval (with technical review) – USD 645
Product Certification/Approval (with clinical investigation data review) – USD 1342
LOCAL FEES (Manufacturer): There will be fees charged for the KGMP certification, however, the amount varies depending on the audit institution.
KGMP Certificate – 3 years
Product registration certificate – certificate issued before October 8, 2020 is valid indefinitely although MFDS might re-issue the certificate with a validity. License issued after October 8, 2020 is valid for 5 years.
LICENSE TRANSFER: License transfer process is possible. The old license holder should transfer all the rights and obligations to the new license holder. The timeline is 10 working days.
AUTHORIZED REPRESENTATIVE: Foreign companies, without an establishment in Korea, are required to appoint a local Authorized Representative (AR).
SPECIAL REQUIREMENTS: KGMP certification is mandatory for all devices, including Class I. The manufacturing site information must be listed in the product license as well. Inspection might also be required for higher classes (II, II, IV). Local clinical studies may be requested for some devices which are impacted by race difference.
For more information on Medical Device Registration in South Korea, check out the following articles on our blog!