South Korea medical device regulations
Official sources linkedMFDS rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| MFDS Notice No. 2026-18 — Annex 1 | Medical Device Items and Item-Specific Classes Current consolidated Annex 1 to MFDS Notice No. 2026-18: 2,168 active item codes with Korean and English names, definitions, and Classes 1–4. The authority PDF also displays 279 deleted historical codes; the corpus excludes those rows because they have no current class. | Classification | March 9, 2026 | Official |
| Medical Devices Act | Korean Medical Device Regulatory Framework MFDS overview of the Medical Devices Act, its enforcement rules, risk classes I–IV, and the notification, certification, and approval pathways for devices marketed in Korea. | General | — | Official |
| MFDS Notification No. 2022-52 | Permission, Notification and Review of Medical Devices Detailed MFDS rules for device permission, notification, technical-document review, and changes to approved or certified products. | Registration | — | Official |
| MFDS Medical Device GMP Regulations | Medical Device Good Manufacturing Practice Regulations Current English MFDS compilation of Korean medical device GMP regulations and standards for manufacturers and importers. | GMP/QMS | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Continue from regulations into practical research
Keep South Korea as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Classify a device for South Korea
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Compare products across markets
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Build a registration plan
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Compare existing evidence against South Korea needs.
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