South Korea
- Regulatory Authority:
Ministry of Food and Drug Safety (MFDS)
- Legislation:
Medical Device Safety Act dated 6 July 2017 No.17265
- Registration period:
Class I: 1 month
Class II: 4–6 months
Class III and IV: 6–10 months
- Language of labeling and documentation:
Korean, English
- Certificate validity period:
KGMP certificate is valid for 3 years
- Authorized Representative:
country resident
A brief algorithm for registration of medical devices in South Korea:
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)
05