Registration of Medical Device and In Vitro Devices In Morocco By Online
- Medical devices are controlled by the Bureau of Medical Devices, which is a division within the Department of Medicine and Pharmacy.
- Devices for medical use are classified by risk and classified in accordance with the directive on medical devices 93/42/EEC, Class I, IIaand IIb and III
Application procedure:
- The applicant must visit at the Direction du Medicament et de la Pharmacie (DMP) with all the required information and then go to the desk of service and ask for assistance.
- Then, submit the application to the official responsible for the visit who will validate the information and then pay the application fee.
- For devices of higher quality the need for samples could be necessary to be taken for testing to National Laboratory for Medical Control (LNCM) to test
- The application will be assessed then verified and reviewed through the medical panel If all the details are correct, you will be issued the license through the register of licences
NOTE:Foreign Manufacturers must designate an Authorized Representative in their local territory.
Every shipment that goes towards Morocco needs an export permit. Send documents before delivering. Approval is approx. 2 weeks.
Required Documents For Registration of Medical Device and In Vitro Devices
- Authorization from the manufacturer to allow a local business to sell and register the product.
- EC Certificate, FDA Certificate or FSC (Free Sales Certificate).
- ISO 13485 certificate or equivalent.
- EC Declaration of Conformity of Equipment that includes accessories and components.
- Nameplates, labels or photos (equipment and accessories) that are signed and stamped.
- User manuals.
- Technical file Information about the Product Maintenance Guide, Specifications for Technical Use Qualifications, Tests for controls Final Test Report Production Flow Chart Manufacturing Process Description.:
- Color catalog in PDF (original).
Office Locations and Contacts
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:info.dmp@sante.gov.ma
Eligibility
Foreign and local manufacturers
Fees
- Renewing or registering licences up to 1000 DH
Validity
The license is valid for 5 years.
Processing Time
- In between 6 and 8 months if all details are correct.
Instructions
The language used to label medical devices must be in Arabic or French
The Document is required
The goal of the registration of medical devices by the Direction du Medicament et de la Pharmacie (DMP) is to protect patients as well as the general public by making sure that all medical products that are available throughout the country are registered.
- Secure
- Efficacious
- Of good quality
- Affordable to the local market
Information that could be helpful
Pre-owned Medical Devices, About 20% of the imports of medical devices is either used or recycled. When it comes to used equipment, exporters have to supply Moroccan purchasers with these information:
- Certification of compliance
- FDA authorization,
- The technical manual and instructions for the use of the product.
- Certification of radiological and electro-technical working order
- The documentation on maintenance done previously.
When a company or its agent has registered medical Devices in Morocco and a third-party is not legally able to import the identical Devices that are in used or refurbished condition without the Devices being subjected to fresh safety inspections. Any piece used, or new medical equipment that is imported into the country the third party has to present the same documents as previously mentioned.
External Link
Directorate of Medicines and Pharmacy