Morocco medical device regulatory resources

AMMPS holds the operational device competences; the registration certificate issues in the name of the administration

Medical devices are 'produits de santé' for the purposes of loi 10 22, which expressly includes 'les dispositifs médicaux au sens de la loi n° 84 12'. The Agence Marocaine du Médicament et…

Registration is granted after consultation of the national consultative medical-device commission

The registration certificate for a medical device is delivered by the administration after consultation of the 'commission nationale consultative des dispositifs médicaux'; the same commiss…

Décret n° 2-14-607 (18 September 2014) implements loi 84-12

Décret n° 2 14 607 of 22 kaada 1435 (18 September 2014) is the implementing decree of loi 84 12. It fixes the establishment declaration procedure, the registration application route to the…

Loi n° 84-12 is the primary medical-device statute (dahir n° 1-13-90, 30 August 2013)

Medical devices are governed by loi n° 84 12 relative aux dispositifs médicaux, promulgated by dahir n° 1 13 90 du 22 chaoual 1434 (30 août 2013) and published in Bulletin officiel n° 6188.…

Statutory device definition based on intended medical purpose and non-pharmacological principal action

A medical device is any instrument, apparatus, equipment, material, product or other article used alone or in combination, including accessories and software involved in its operation, inte…

Classes I, II A, II B and III (loi 84-12 art. 4)

Classe I — risque potentiel faible, Classe II A — risque potentiel modéré, Classe II B — risque potentiel élevé, Classe III — risque critique

Single national registration certificate required before placing a device on the market

Placing a medical device on the Moroccan market requires a prior registration certificate (certificat d'enregistrement). The application is filed with the AMMPS/Ministry of Health by a manu…

Customs release gated on the registration certificate, a filing receipt, or visaed invoices

Moroccan customs are instructed to make the import AND export of medical devices subject to presentation of a registration certificate or, as the case may be, a specific authorisation issue…

Full technical documentation waived for imported devices; only class III clinical data required

statement: For imported medical devices the registration dossier's technical part is lighter than for locally manufactured devices: under arrêté n° 2855 15 art. 2, 1) b) the technical piece…

Origin-country CE / FDA / free-sale certificate is a mandatory dossier item for classes Is, Im, IIA, IIB and III

statement: A medical device registration application must include a certificate issued by the competent authority of the country of origin: an EU CE marking certificate, an 'FDA' attestatio…

The Moroccan 'certificat de libre vente' is an OUTBOUND export certificate, not an inbound import requirement

In Moroccan law a 'certificat de libre vente' for medical devices is a document the administration issues TO an export establishment, attesting that the devices concerned conform to the goo…

The registration applicant must be a declared Moroccan manufacturing or importing establishment

The registration certificate is granted only to a manufacturing or importing establishment that has been declared to the administration in Morocco. A foreign manufacturer cannot hold the Mo…

Manufacturing, import, export, distribution and maintenance establishments must be declared with a full technical file

Any establishment manufacturing, importing, exporting, distributing or maintaining medical devices must be declared to the administration before starting activity. The declaration file must…

Seventeen-item paper dossier plus electronic copy generated by the AMMPS DES-DM module

The registration dossier is a fixed 17 item paper file: application letter in triplicate; fiche signalétique in triplicate; manufacturer's attestation evidencing the manufacturer–applicant…

No source-verified answer is published for this dimension yet.

Labels of imported devices must add the importer's name and address and the registration-certificate number and date to the manufacturer's particulars

Point 13.3 of the essential requirements lists the mandatory label indications. Item a) requires the name or company name and address of the manufacturing establishment and, for medical dev…

Every package must contain an instruction notice, except class I and IIA devices usable safely without one; symbols and identification colours must follow harmonised standards

Under point 13.1 each device must be accompanied by the information needed to use it safely and identify the manufacturer, taking account of users' training; the package of each device must…

Inspections by at least two sworn inspectors, one of them a pharmacist inspector

Inspection is carried out on the order of the Minister of Health by at least two inspectors, at least one of whom must be a pharmacist inspector. Inspectors take an oath before the court of…

ANRT radio-equipment agrément

Wireless / radio

ANRT telecommunications terminal equipment agrément

Telecom terminal

AMSSNuR authorisation for ionizing-radiation installations and sources

Radiation

Certificat d'enregistrement d'un dispositif médical

1 000 MAD (TTC)

Certificat d'enregistrement d'un réactif à usage diagnostic in vitro

500 MAD (TTC)

Initial device registration — all risk classes · National dossier review: the application is addressed to the Minister of Health and the certificat d'enregistrement is delivered by the administration after consultation of the commission nationale consultative des dispositifs médicaux (loi 84-12 arts. 12 and 14; décret n° 2-14-607 art. 4)

120 days

Post-registration update (mise à jour) of the certificate · Update application under arrêté n° 2855-15, distinct from a fresh registration application where the change bears on the nature of the device (loi 84-12 art. 16)

20 days

ANRT agrément — radio and telecommunications terminal equipment · Prior agrément by equipment, delivered by the ANRT on application to its services (Décision ANRT/DG/N°16/24 arts. 2, 3 and 11)

15 days

Registration certificate valid five years, renewable

The device registration certificate is valid for a renewable period of five years, under conditions fixed by order of the Minister of Health. For used or refurbished devices, validity is li…

Renewal requires a manufacturer-issued five-year materiovigilance review and a no-change declaration

A renewal application must carry, for all risk classes and all devices, administrative items (application in triplicate, copy of the fee receipt, fiche signalétique in triplicate with an el…

Dossier changes notified in writing; a change in the nature of the device requires a fresh registration

The registration holder remains responsible for the ongoing evaluation of the clinical data of its products as scientific knowledge evolves and must notify the administration in writing of…

Post-registration update decided within a maximum of 20 days; notification letter in triplicate

The administration decides on an application to update a device registration certificate within a maximum of twenty days from the date the complete dossier is filed; any refusal must be jus…

Traceability rules apply to designated devices according to degree of danger; list fixed by regulation

Persons responsible for establishments manufacturing, importing, exporting and distributing medical devices, health establishments and health professionals must apply traceability rules to…

Registration requires a prior clinical investigation or a literature-based clinical evaluation with proven equivalence

The registration certificate may be issued only if the device has first been the subject of either a clinical investigation carried out under the legislation in force, or an evaluation of c…

Exceptional authorisation for urgent public-health need pending registration

Where public health needs require it, and in an emergency, the government authority responsible for health may exceptionally authorise the placing on the market and putting into service of…

The manufacturing establishment must produce a materiovigilance review covering the last five years for every renewal, whatever the risk class

For the renewal of a registration certificate the technical part of the file must contain, for all risk classes and all devices, a materiovigilance review of the last five years issued by t…

Declared establishments and their subcontractors must follow good practices of performance evaluation of devices, defined as NM ISO 13485

Article 11 of loi 84 12 obliges manufacturing, importing, exporting and distribution establishments and their delegatees to comply with the rules of good practice for manufacture, transport…

National materiovigilance system; incidents reportable to the administration within 48 hours

Materiovigilance covers the surveillance of incidents or risks of incidents arising from the use of medical devices after they are placed on the market, through a national materiovigilance…

Administration may order cessation of distribution and recall; urgent suspension with 60-day limit

Where it appears to the administration that a device may present risks to public health, it immediately notifies the registration holder and invites observations within fifteen days. On the…

Only registered devices may be advertised; advertising is subject to a prior visa

Only medical devices holding a registration certificate may be advertised to the public. Advertising must not be misleading or harm the protection of human health; it must present the devic…

Refusal must be reasoned and notified; AMMPS operates a recours channel

Any refusal of a device registration must be reasoned and notified to the applicant. The AMMPS publishes a 'Déposer un recours' channel on its site alongside its 'Déposer une réclamation' c…