Morocco - Registration of Medical Device and In Vitro Devices

ProcedureEdit

Medical devices are regulated through the Bureau of Medical Devices, a division of the Department of Medicine and Pharmacy.
Medical devices are classified according to risk and are categorised according to the medical devices directive 93/42/EEC - Class I, IIa, IIb & III

How to apply:

Applicant should visit the Direction du Médicament et de la Pharmacie (DMP) with all the requirements and approach the service desk and request for assistances
Submit the requirements to the attending official who will verify them and pay the required application fees
In the case of higher class devices, samples may be required to be sent to the National Laboratory for Medical Control (LNCM) for testing
Your application will be evaluated, verified and processed by the medical committee, if all the information are in order, you will be issued with the licences by the licences register

Note :
Foreign Manufacturers must appoint a Local Authorized Representative.
Each shipment to Morocco requires an import permit. Submit documents prior to shipment. Approval appx. 2 weeks.

Required DocumentsEdit

Authorization of the manufacturer to permit a local company to register and market the products.
EC Certificate, FDA Certificate or FSC (Free Sales Certificate).
ISO 13485 certificate or equivalent.
EC Declaration of Conformity of Equipment with components and accessories.
Labels or nameplates photos (equipment and its accessories), signed & stamped.
User manuals.
Technical file: Product Data, Maintenance Manual, Technical Specifications, Qualifications, Tests of controls, Final Test Report, Flow Chart, Manufacturing Processes Description.:
PDF color catalog (original).

Office Locations & ContactsEdit

Directorate of Medicine and Pharmacy:
Rue Lamfadal Charkaoui BP 6206 - Rabat Institute - Morocco
Tel: +212 537 682 289 / +212 537 770 645
Fax: + 212 537 681 931
Email:[email protected]

EligibilityEdit

Local and foreign manufactures

FeesEdit

Registration/renewal of licences 1000 DH

ValidityEdit

The licences is valid for 5 years

Documents to UseEdit

Please attach documents that can be used by people. e.g. links

Sample DocumentsEdit

Please attach sample completed documents that would help other people.

Processing TimeEdit

Within 6 to 8 months if all the information are in order.

InstructionsEdit

The medical devices labelling language requirement should be either in Arabic or French

Required InformationEdit

A list which displays the kind of information which is required to complete the procedure.
e.g.
1. Date of Birth.
2. City or County of Birth.

Need for the DocumentEdit

The objective of registration of medical device by the Direction du Médicament et de la Pharmacie (DMP) is to protect patients and the general public by ensuring that all medicinal products circulating in the country are

Safe
Efficacious
Of good quality
Suitable/appropriate to the local market

Information which might helpEdit

Pre-Owned Medical Devices, Approximately 20 percent of the total imported medical equipment is used or reconditioned. For used equipment, the exporters must provide Moroccan buyers with the following:

Compliance certificate,
FDA authorization,
The technical documentation and directions for use of the product
Certification of electro-technical and radiological working order
Documentation on previous maintenance.

When a manufacturer or its agent has registered a medical Devices in Morocco, a third party cannot legally import the same Devices in used or refurbished condition without the used Devices being subjected to new safety inspections. For any piece of used or refurbished medical equipment that enters the country, the third party must provide the same documentation as described above

External LinksEdit

Directorate of Medicines and Pharmacy

OthersEdit

More information which might help people.