Senegal medical device regulations

The decree that governs medical devices in Senegal: four chapters and 48 articles plus an annex, covering the general provisions, the classification of devices (including the paragraph on devices other than IVDs), the conditions of manufacture, import, export and distribution, and the transitional and final provisions — with Annexe 1 carrying the essential safety and performance requirements. Article 28 is the établissement-agrément power the ARP has since exercised by arrêté. It is the corpus parent of the vigilance decree row below: both were published in the same issue of the Journal officiel, the issue is the only retrievable official copy of either, so the extract `journal-officiel-7704-fr.json` is the whole gazette issue (the seven decrees 2023-2418 to 2023-2424 and the annonces section, 314 blocks) and this record's text is the 48 articles and the annex that carry the `dec-2419-` block ids. The issue is the publication of the decree, dated 24 February 2024; the decree itself is dated 27 December 2023 and states no effective date of its own, so none is recorded.

The decree that institutes Senegal's national vigilances system — the framework the ARP's device vigilance and materiovigilance obligations hang on: its scope and definitions, the organisation and operation of the system, the duties it places on the natural and legal persons who take part in it, and its implementing provisions, in 28 articles across four chapters. It is a DIFFERENT legal instrument from Décret n° 2023-2419 and is not an appendix to it; the two are separate decrees of 27 December 2023 that share one publication. This row is a metadata view, not a second corpus copy: the retrievable official copy of both decrees is the single Journal officiel n° 7704 issue, so the view opens the thirty-three blocks that the issue prints under the `dec-2423-` ids inside the extract that Décret 2023-2419 owns. It has no extract, no catalog entry and no HTML of its own, and it is deliberately absent from the batch's ingested-document rows — it is the second decree derived from one gazette, not a second ingested document.

The fees decree: the redevances the pharmaceutical regulation sector raises and how they are collected, applicable to the establishments and products the ARP regulates. Seven articles — the redevances and their basis, the liquidation and collection machinery, the consequences of non-payment, the resources the proceeds are assigned to, and the transitional and final provisions — with the tariff table carried in the extracted text as the decree's articles list it. Adopted 18 November 2025 and published in the Journal officiel n° 7871 (numéro spécial) of 29 December 2025; the gazette date is the publication date recorded here and the decree states no separate effective date. It is the fees instrument for the regime Décret n° 2023-2419 sets up, and it is a decree of the Ministry of Finance and Budget published like any other, not an ARP act.

A REGIONAL INSTRUMENT, and a MEDICINES one: the ECOWAS Joint Assessment Procedure run by the West African Health Organisation (WAHO/OOAS) under West Africa Medicines Regulatory Harmonization, in which a medicine dossier is assessed once by a coordinating national regulator and an expert working group and the outcome is then acted on nationally. It sets out the scope of products, the joint assessment pathway step by step (expressions of interest, the pre-submission meeting, dossier submission and screening, the evaluation phases, the joint GMP inspection and quality-control testing, the steering-committee validation), the reporting of results, the outcome, maintenance of registration status, national authorisations and the WHO collaborative assessment pathway alongside it. It is filed under ONE market — Senegal, this batch's market — under the round's rule for instruments that apply across several countries. It is NOT a medical device instrument and this row does not claim it is: the batch triage note carried the lead inside a device workstream, and the correction is that the procedure is for medicinal products, so it is recorded here as the regional medicines procedure a Senegalese device applicant reads only for the shape of joint assessment, with no device obligation arising from it. The copy is dated September 2022 on its cover.

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.