{"id":4496,"date":"2017-07-20T16:37:06","date_gmt":"2017-07-20T14:37:06","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=4496\/"},"modified":"2024-06-12T15:37:01","modified_gmt":"2024-06-12T13:37:01","slug":"medical-device-registration-morocco","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-morocco\/","title":{"rendered":"Medical Device Registration in Morocco"},"content":{"rendered":"
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Regulatory Authority<\/b><\/h5>\n

Direction du M\u00e9dicament et de la Pharmacie (DMP)<\/p>\n

Classification<\/strong><\/h5>\n

Medical Devices: I, Im, Is, IIa, IIb, III<\/p>\n

In-vitro diagnostic medical reagents: no classification<\/p>\n

Quality System
<\/strong>ISO 13485<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of June 2024. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

To market medical devices and in vitro diagnostics in Morocco, product registration with the Direction du M\u00e9dicament et de la Pharmacie (DPM)<\/strong>, which is responsible for assessing applications, is required. Specifically, the Advisory Committee issues the certificate for Medical Devices.<\/p>\n

The application for registration<\/strong>, to be submitted electronically via the Authorised Local Representative, consists of administrative and technical files. In general, the dossier includes information relating to the device (and its accessories), the establishment declaration of the Authorised Local Representative, the EC marking certificate, the FDA marketing authorisation, or the certificate of free sale issued by the Competent Authorities of the country of origin, labelling, demonstration of compliance with the essential requirements, catalogue (original).  The content and registration procedure may vary depending on the risk class and type of device.  <\/p>\n

A registration certificate can only be issued if the proposed medical device has been the subject of a clinical <\/strong>investigation <\/strong>carried out in the field, a clinical evaluation based on literature, or on substantially equivalent devices already on the market.
On-site clinical investigations may only be required for IVDs.<\/p>\n

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Applicant<\/span><\/h3>\n

A foreign manufacturer wishing to market devices in Morocco must appoint an Authorised Local Representative, i.e., an organisation based in Morocco responsible for compliance with Moroccan regulations, from the product registration stage to post-market surveillance.<\/p>\n

Timeframe and fees<\/span><\/h3>\n

New registrations of medical devices officially take 120 days, while in vitro diagnostic medical devices take a maximum of 12 months.
For the registration of a Medical Device, the fee is USD 111, for IVDs, it is USD 56.<\/p>\n

Validity<\/span><\/h3>\n

Registration is valid for five years from issuance.
To renew registration, the Authorised Representative must submit a formal request with a dossier to the DPM.<\/p>\n

Documentation language and Labelling<\/span><\/h3>\n

Documentation, labelling and instructions for use relating to Medical Devices and IVDs for professional use must be provided in English and\/or French and\/or Arabic. If the devices are intended for non-professional users, the language must be French and\/or Arabic.<\/p>\n

Useful information<\/span><\/h3>\n

Morocco recognises European certification (EC marking) and US certification (FDA) as valid.
The regulatory system consists of \u201cdahirs\u201d, laws, decrees, provisions and decisions issued by the Regulatory Authorities.<\/p>\n

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n