Importer Licence (수입업 허가)
Korean importers of medical devices must hold an importer licence (수입업 허가) from MFDS.
Requirements
- Designated Quality Assurance Manager meeting MFDS requirements
- Business registration in Korea
- Must hold (or be eligible to hold) the 품목허가 / 품목신고 for imported products
Key importer obligations as licence holder
- Ensure foreign manufacturer maintains a valid GMP certificate recognised by MFDS
- Korean-language labelling compliance
- Adverse event reporting for products on the Korean market
- Recalls and FSCAs when required
Application
Submit via MFDS eSubmission portal (의료기기 전자민원).