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Morocco - Registration of Medical Device and In Vitro Devices

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Procedure[edit]

  • 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:

  1. 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
  2. Submit the requirements to the attending official who will verify them and pay the required application fees
  3. In the case of higher class devices, samples may be required to be sent to the National Laboratory for Medical Control (LNCM) for testing
  4. 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.

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Required Documents[edit]

  • 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 & Contacts[edit]

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

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Eligibility[edit]

Local and foreign manufactures

Fees[edit]

  • Registration/renewal of licences 1000 DH

Validity[edit]

The licences is valid for 5 years

Documents to Use[edit]

Please attach documents that can be used by people. e.g. links
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Sample Documents[edit]

Please attach sample completed documents that would help other people.

Processing Time[edit]

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

Related Videos[edit]

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

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Instructions[edit]

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

Required Information[edit]

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.
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Need for the Document[edit]

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 help[edit]

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

Other uses of the Document/Certificate[edit]

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links[edit]

Directorate of Medicines and Pharmacy

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Others[edit]

More information which might help people.

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