Uruguay medical device regulations
Official sources linkedMinistry of Public Health 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 |
|---|---|---|---|---|
| Decreto N° 428/022 (Res. GMC N° 25/21) | MERCOSUR Technical Regulation on Medical Device Registration Uruguay's current medical device framework: Decreto N° 428/022 internalises MERCOSUR Res. GMC N° 25/21 as an integral annex and derogates Decreto N° 7/001 (Res. GMC 40/00). Ingested from IMPO as corpus text: decree articles 1-4, the GMC resolution articles 1-5, RTM Partes 1-5 (scope, risk classes I-IV, registration procedure, conformity of information, administrative sanctions) and Apéndices I-V, including the 22 classification rules of Apéndice II as individually citeable passages. Spanish is the controlling text. | General | January 20, 2023 | Official |
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