Medical Devices Act (의료기기법)
The Medical Devices Act (의료기기법) is the primary legislation governing medical devices in Korea, establishing the framework for classification, pre-market approval, GMP, post-market surveillance, and enforcement.
Key provisions
| Article | Subject |
|---|---|
| Article 2 | Definitions — medical device, manufacturer, importer, grades |
| Article 3 | Classification grades |
| Article 6 | 품목허가 and 품목신고 requirements |
| Article 7 | Manufacturer licence (제조업 허가) |
| Article 15 | Importer licence (수입업 허가) |
| Article 19 | GMP requirements (KGMP) |
| Article 24 | Labelling and advertising |
| Article 30 | Adverse event reporting |
| Article 34 | Recall obligations |
| Article 36 | MFDS inspection authority |
| Article 52 | Penalties |
Official source
Full text at law.go.kr — search: 의료기기법