Repair Business Registration
Entities that repair medical devices in Korea must register as a repair business (์๋ฆฌ์ ) with MFDS.
Requirementsโ
- Business registration in Korea
- Qualified personnel capable of performing the repairs
- Adequate tools, equipment, and facilities for the repair scope
Scopeโ
Required for repair activities on Grade II, III, and IV devices. Grade I may have lighter requirements.
Obligationsโ
- Only repair devices within their qualified scope
- Use genuine parts or approved alternatives
- Keep repair records
- Report adverse events discovered during repair