South Korea - MedStandard

South Korea

Ministry of Food and Drug Safety (MFDS)

Medical Device Safety Act dated 6 July 2017 No.17265

Class I: 1 month

Class II: 4–6 months

Class III and IV: 6–10 months

Korean, English

KGMP certificate is valid for 3 years

country resident

A brief algorithm for registration of medical devices in South Korea:

01

Classification determination of the device according to the MFDS classification list

02

Appointment of an authorized representative - certificate holder

03

If the device is not in the lowest risk classification, apply for Korean Good Manufacturing Practice (K-GMP) certification to an authorized third-party auditor and ship the device to South Korea for all required testing (or to a laboratory outside of South Korea that can perform MFDS compliant testing)

04

Pay all applicable fees

05

Upon approval, the examining authority issues a marketing authorization and publishes the device's registration record on the MFDS website

Final price and terms procedures will be calculated according to your request