Manufacturer Licence (제조업 허가)
Korean manufacturers of medical devices must obtain a manufacturer licence (제조업 허가) from MFDS before manufacturing for the Korean market.
Requirements
- Designated Quality Assurance Manager (품질책임자) — must meet MFDS educational and experience requirements
- Manufacturing site meeting KGMP requirements
- Adequate facilities for the intended manufacturing activities
Application
Submit via MFDS eSubmission portal:
- Application form
- Facility description and layout
- Organisational chart
- Quality Assurance Manager credentials
Annual renewal
Manufacturer licences must be renewed annually. Failure to renew results in licence lapse.