Ecuador medical device regulations
Official sources linkedARCSA 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 |
|---|---|---|---|---|
| ARCSA-DE-2026-003-DASP | Substitute Medical Device Registration, Control and Surveillance Regulation New substitute technical health regulation for medical device registration, control, and surveillance. Published in May 2026 with a nine-month transition period before it replaces the prior framework. | General | January 28, 2027 | Official |
| ARCSA-DE-2023-016-AKRG | National Technovigilance System Substitute technical regulation for Ecuador’s National Technovigilance System. Replaces ARCSA-DE-003-2017-CFMR and sets adverse-event reporting and field-action duties. | Vigilance | June 19, 2023 | Official |
| ARCSA-DE-026-2016-YMIH | Medical Device Sanitary Registration and Control Regulation Current framework for sanitary registration, quality, safety, efficacy, surveillance, and control of human-use medical devices and the establishments that manufacture, import, distribute, or sell them. | Registration | January 12, 2017 | Official |
| ARCSA-DE-2024-048-DASP | Advertising and Promotion Controls for Medical Devices Sets post-market controls for advertising and promotion, including over-the-counter medical devices, and requires claims to remain consistent with the approved sanitary registration. | Labeling | — | 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.
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