Medical Device Registration and Approval in South Korea

General country-specific regulatory information is provided on this page for medical device registration and approval in South Korea. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including South Korea, to expedite the preparation of your medical device or IVD registration application.

Medical device regulations and classification in South Korea

 

REGULATORY AUTHORITY: Ministry of Food and Drug Safety (MFDS)

CLASSIFICATION SYSTEM: Medical Devices and IVDs: I/II/III/IV

TIMEFRAME:

Official Timeline

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.

LICENSE VALIDITY:

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.

Last updated on June 17, 2021.

For more information on Medical Device Registration in South Korea, check out the following articles on our blog!

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