Macau medical device regulations
Official sources linkedISAF 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 |
|---|---|---|---|---|
| Administrative Regulation No. 11/2026 | Implementation Rules for the Medical Device Regime Implements Law 12/2025 through detailed requirements for registration, filing, business licences, submissions, changes, renewals, and regulatory administration. | Registration | July 1, 2026 | Official |
| Dispatch No. 36/2026 | Macao SAR Medical Device Classification Catalogue Official Gazette Dispatch No. 36/2026 classification catalogue, effective 1 July 2026: 4,648 product-type rows across Class I (1,282), IIa (1,550), IIb (1,297), and III (519), preserving the Gazette category headings and duplicate published rows. | Classification | July 1, 2026 | Official |
| ISAF Order No. 1/2026 | Medical Device Classification Rules and Technical Requirements Defines Macau’s risk-based Classes I, IIa, IIb, and III and the technical requirements used to classify devices under the new regulatory regime. | Classification | July 1, 2026 | Official |
| Law No. 12/2025 | Medical Device Supervision and Administration Regime Macau’s lifecycle framework for medical device registration or filing, clinical investigation, manufacturing, import/export, wholesale, retail, supply and post-market control. The official portal is available; a multi-instrument bilingual compilation is not treated as a single citeable expression of Law 12/2025. | General | July 1, 2026 | Official |
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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.
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