Comoros medical device regulations

Signed decree dated 24 January 2017 establishing ANAMEV, retained in full as the authority instrument expressly cited by its device-evaluation committee Decision No.010 of 2026. It sets out the agency’s governance, health-product control and inspection powers, and financial organization. Some provisions specifically concern medicines; the decree does not expressly name medical devices or IVDs and does not itself supply a device registration procedure. Currentness, later health-code amendments and their promulgation measures, and implementing instruments under Articles 9, 17 and 22 remain unverified.

Decision bearing 31 August 2026 establishes evaluation committees. The selected device provisions explicitly include active implants, IVDs, custom-made devices, equipment and single-use devices, with the device committee composition and shared evaluation/administration provisions. Medicines/cosmetics committee-specific material is omitted. Article 20 calls the instrument an arrêté; the source wording is retained. Currentness and referenced amended parent law remain unverified.

Complete 119-page Public Health Code supplied by the Ministry of Justice. Articles 396–402 define medical devices, including active implantable devices, and address importation, placing on the market, conformity certification and incident reporting. Article 403 begins pharmacist-profession provisions. The device title delegates device lists, supply conditions, certification exemptions and procedures, and seller authorizations to implementing orders or decrees. It does not separately identify IVDs; product-specific IVD coverage requires confirmation from the applicable amended definitions and implementing texts. The 2020 amending law and relevant implementers have not been acquired, so current applicability remains unverified. The complete code is retained for context.

Official reagent-dossier checklist dated 3 September 2026. Selected French body covers administrative and technical documents, samples, French-language packaging/leaflet and initial and renewal fees by classes A–D, plus separate major and minor variation fees. Arabic letterhead and graphical stamp/signature are preserved in the full raw original, not transcribed. Parent law 20-003/AU remains an unresolved dependency; currentness is unverified.

Official sterile medical consumables dossier checklist dated 3 September 2026. Selected French body covers administrative/manufacturing documentation, stability, samples, French-language packaging/leaflet and initial and renewal fees by classes A–D, plus separate major and minor variation fees. The incomplete printed title and “Nouvel demande” are retained. Currentness remains unverified.