Décision n° 03/2022/CM/UEMOA du 24 juin 2022, annexes

A REGIONAL INSTRUMENT, not a Senegalese one: the lignes directrices annexed to Décision n° 03/2022/CM/UEMOA of 24 June 2022, by which the UEMOA Council of Ministers harmonised medical device regulation across the Union's eight member States (Benin, Burkina Faso, Côte d'Ivoire, Guinea-Bissau, Mali, Niger, Senegal and Togo). It is the operative content of that decision — contexte, definitions, classification and the requirements attached to each class, the responsibilities of national regulators and of manufacturers, representatives, importers/exporters and distributors, market placement and putting into service (homologation, listing, the application dossier, the fees) and market surveillance, with five annexes carrying the classification rules, the essential requirements for devices and for IVDs, the declaration form and the homologation dossier contents. It is filed under ONE market — Senegal, this batch's market — under the round's rule for instruments that apply across several countries, the same ruling recorded for the EAEU instruments under Armenia and the Union instruments under the EU member States; the other member States read it through this row. Its publisher is the UEMOA Commission, not the ARP: the retrievable copy is the one the Agence Béninoise du Médicament publishes, and the instrument states no dates of its own (neither publication nor entry into force), so none are recorded.

Décision n° 03/2022/CM/UEMOA du 24 juin 2022, annexes is the official identifier ARP uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.