Morocco medical device regulations

Arrêté n° 1679-14 of 12 rejeb 1435 (12 May 2014), published in the Bulletin officiel n° 6274 of 19 ramadan 1435 (17 July 2014), made under décret n° 2-12-502 of 13 May 2013 on the general safety obligation for products and services. Thirteen articles in four chapters: the obligations of the producer, the importer and the service provider (traceability, the safety assessment they must be able to show, and the corrective action they must take), the obligations of the distributor, the duties of the administration, and the final provisions. A medical device is a product within this order, so it is the general-market safety layer beneath the device-specific regime, and it is the instrument that reaches a device the AMMPS regime has not registered. The extract was built from the gazette's two-column setting by cropping each column; it preserves the source's own headings, in which the first article is printed "ARTICLE PREMIER." in capitals while the rest are printed "A RT. n." with letter-spacing from the typesetting, and the first chapter is "Chapitre premier" with no numeral while the second is "Chapitre II".

Checklist d'enregistrement des dispositifs médicaux, Réf. DE ER DM/01, édition 9 — the form a device registration file is checked against. Three parts: Partie A, what the applicant fills in (the object of the application, the type of device, its status and its risk class); the part reserved for the administration, which lists the pieces of the file in paper form and marks each one received, not applicable, missing or observed; and the notes and referrals, which state that every piece must be dated, signed and stamped by the Moroccan establishment's legal representative and that a change to the nature of the device requires a fresh application. It is the operational checklist for the same registration the device law establishes. The document's own two pages disagree with each other: page 1 carries "Edition : 9 / Date d'application : 30/01/2025" while page 2 still carries "Edition : 8 / Date d'application : 10/08/2020". The edition the cover states is recorded on this row and both are visible in the extract.

The user manual for DES-DM, the automated module that generates a standardised electronic device registration file. Three sections: the system prerequisites, the installation steps for the DES-DM application, and the procedure for using it — from entering the establishment's details and creating a submission list through to producing the standardised file. It is the instructions that go with the checklist on this page: the checklist says what has to be in the file, and this manual says how the electronic file is produced and submitted. The document carries no reference number, version or date of its own, so none is recorded.

Circulaire n° 5663/311 of 3 March 2017 from the Customs administration, on the importation of medical devices, issued under section 02, chapter 20 of the RDII (the customs codes). It recalls the device definition in loi n° 84-12, states which devices are exempt from the import authorisation the Ministry of Health grants, and instructs customs officers on the documents a device import file must carry. It is the instrument that decides whether a consignment is released at the border, so it is read with the AMMPS registration rather than instead of it. The circular is a single continuous text with no article structure, and its extract is one body block.

AMMPS-LD EA-013, version 1.0, dated 10/02/2026 — the mechanisms by which the AMMPS relies on another authority's assessment when it registers a product. Nine sections and one annex: definitions and terminology, the key concepts of reliance, the reliance mechanisms with their assessment timelines, the assessment elements, the product 'sameness' test, assessment reports, the life-cycle approach, reference documents and associated documents, followed by Annexe 1, the comparative elements to be included in a 'sameness' attestation. Its title and its body are expressly about l'enregistrement des médicaments — medicines — not medical devices; it is ingested as a medicines reliance instrument, and the reliance concepts it sets out are read across to devices rather than being claimed as device guidance. It sits under AMMPS-LD RE-001 as the operational detail of the recognition routes that guideline establishes.

AMMPS-LD RE-001, version 1.0, dated 26/02/2026 — the Agency's framework guideline for taking regulatory decisions on the basis of another authority's work. A preface, a list of abbreviations, then sections I–VII: introduction, objectives, scope, the recognition-based routes, the domains of recognition, the regulatory authorities the AMMPS recognises, and the references. Section V is the substance: registration and marketing authorisation, pharmacovigilance, good-manufacturing-practice inspections, quality control and batch release of vaccines and sera, and authorisation of biomedical research. Section VI names the recognised authorities — WHO-listed authorities and maturity-level 3 and 4 authorities, and the international organisations Morocco belongs to. The guideline's own subject matter is medicines and vaccines, and it is ingested here because it is the jurisdiction's recognition instrument; the device-specific reliance mechanisms sit in the AMMPS device procedures rather than in this text. Two source artefacts are recorded rather than normalised: the cover reference is AMMPS-LD RE-001 while every page footer prints AMMPS-LD DG-001/ Ver. : 1.0, and section IX of the guide is followed only by the abbreviations and references the contents page promised, so the body and the contents page do not enumerate the same list.

Loi n° 10-22 creating the Agence marocaine du médicament et des produits de santé, promulgated by dahir n° 1-23-54 of 23 hija 1444 (12 July 2023). Twenty-seven articles in six chapters: the Agency's name and purpose, its missions (Article 7 lists them, including the cooperation and harmonisation mandate the reliance guideline cites), its administrative and management organs, its financial organisation, its human resources, and transitional and final provisions. Article 2 defines médicament et produits de santé by reference to the medicines code and to loi n° 84-12 for medical devices, which is what puts devices inside the Agency's remit and makes this law the reason the same agency owns both the device and the medicines corpus. This file is the French text as carried in the Bulletin officiel n° 7462 of 13 joumada II 1447 (4 December 2025), which is the gazette page the AMMPS serves; the law's own promulgation date is 12 July 2023, and both dates are stated here because the gazette date is not the date of the law.

Loi n° 84-12 relative aux dispositifs médicaux, promulgated by dahir n° 1-13-90 of 22 chaoual 1434 (30 August 2013) and published in the Bulletin officiel n° 6188 of 12 kaada 1434 (19 September 2013). Fifty-one articles in six chapters: general provisions (the device definition and the certification and conformity regime), the establishments that make, import, export and distribute devices, the conditions for placing a device on the market and putting it into service, the National Consultative Commission on Medical Devices, inspection and penalties, and final provisions. This is the law a Moroccan registration is granted under, and the AMMPS forms and checklists on this page are the procedural layer beneath it. Two source artefacts are preserved in the extract rather than repaired: the article that requires a conformity certificate prints its heading as "Article14" with no space, and the gazette's running head was removed as page furniture while every article heading was kept exactly as printed.