South Korea
South Korea is a highly technological market for medical devices, with strong demand for innovative and digitalized products.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Food and Drug Safety (MFDS).
Device Classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Very high risk
Specific Local Requirements
| Language | Documentation in Korean. |
| Local Representative | Required for foreign manufacturers. |
| Local clinical trials | May be required for advanced devices. |
Challenges and Operational Advice
- Strict regulations: Stringent requirements for Class III and IV devices.
- Complex process: The procedure may take up to 18 months.
Why Choose ISEMED
- Asian Expertise
Expert support for accessing the South Korean market. - Certification Assistance
Help in complying with MFDS regulations.
FAQ
- Is a local representative required? Yes.
- Documentation language? Korean.
- License duration? 5 years.