Mali medical device regulations
Official sources linkedDirection de la Pharmacie et du Médicament 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 |
|---|---|---|---|---|
| Décret n°04-557/P-RM du 01 décembre 2004 | Produits du domaine pharmaceutique — définitions et contrôle d’importation des dispositifs médicaux et réactifs (extraits) Selected MD/IVD-related provisions of Décret04-557/P-RM: complete identity/preamble; Article1 and complete Article2 definitions as scope context; Article17 enabling a joint order to identify pharmaceutical-domain products not requiringAMM but subject to import control; Article18 repeal clause; and Article19 execution/publication with all six printed signatories. Article2(e) separately names sterile medicaldevices, conditioned diagnostic/pregnancy reagents and parenteral syringes/needles. Medicine-only AMM validity, fee and variation provisions are not extended to all devices. Known implementing Arrêté05-2203/MS-MEP-SG expressly applies04-557 and its Articles26–32 provide the specific non-AMM import-control mechanism for sterile/nonsterile devices and laboratory reagents; that separate expression is not merged here. This plan publishes selected regions on physical19–22 of a40-page Gazette, not the full pharmacy decree or fullGazette. Printed signing date1December2004 is clear. Containercover prints20Mars2005 whereas runningheaders on19/21 print20Janvier2002; discrepancy retained, no precise publication/effective date assigned. Later amendments and currentness remain unverified. | General | — | Official |
| Manuel DPM, validation décembre 2020 / application janvier 2022 | Manuel de procédures pour l’enregistrement des médicaments à usage humain au Mali Complete 81-page official manual, including medical-device registration, classification and dossier requirements alongside medicines, cosmetics and nutritional products. The cover states validation in December 2020 and entry into effect in January 2022; no exact calendar day is invented. The original French text is transcribed by OCR from the authority’s scanned PDF. | Registration | — | Official |
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