Medical devices
Mandatory registration before placing on the Moroccan market: technical file, evidence of conformity (e.g. ISO 13485 certificate, CE marking or equivalent, certificate of free sale), then follow-up until the decision.
Our regulatory experts prepare, submit and follow up your files with the AMMPS and the ONSSA, on your behalf. Turnkey or task by task.
An incomplete authorisation file means months lost in back-and-forth with the administration. Our experts know the required documents, the expected formats and the points the authority checks first.
Legal responsibility for the product remains with its owner, the authorisation holder. exoqual prepares, submits and follows up the files in the owner's name, and can provide post-authorisation follow-up on their behalf, product recalls included.
Mandatory registration before placing on the Moroccan market: technical file, evidence of conformity (e.g. ISO 13485 certificate, CE marking or equivalent, certificate of free sale), then follow-up until the decision.
Sanitary approval or authorisation of the establishment, preparation of the sanitary inspection, then health certificates for each shipment to the destination country.
Registration prior to manufacturing, import and placing on the market: composition, labelling and documents required by the authority.
A single point of contact for the whole journey, per product or per range.
We identify the regulatory pathway, the competent authority, the missing documents and a realistic timeline.
If the required quality system is not in place (ISO 13485, HACCP, ISO 22000…), we build it with you through our quality services.
Drafting, compiling, labelling, then submission to the authority on your behalf.
We answer requests for additional information and follow the file until the authority's decision.
Regulatory watch, renewal preparation and organisation of product recalls if needed.
Each task can be ordered on its own.
| Task | Medical devices | Food exports | Cosmetics & supplements |
|---|---|---|---|
| Regulatory assessment Product classification, competent authority, regulatory pathway, missing documents, timeline. | ✓included | ✓included | ✓included |
| Technical file preparation Drafting and compiling the documents required by the authority. | ✓included | ✓included | ✓included |
| Labelling and leaflets Bringing labels, packaging and leaflets into compliance, French and Arabic versions included. | ✓included | ✓included | ✓included |
| Submission and follow-up Submission on your behalf, follow-up, responses to the authority's requests for additional information. | ✓included | ✓included | ✓included |
| Sanitary inspection preparation Upgrading the establishment and support on the day of the inspection. | —not applicable | ✓included | —not applicable |
| Export health certificates Preparing the certification files for each shipment. | —not applicable | ✓included | —not applicable |
| Renewals and variations Renewal of registrations, variations, transfers of registration. | ✓included | ✓included | ✓included |
| Monitoring and recalls Regulatory watch, incident follow-up and organisation of product recalls on your behalf. | ✓included | ✓included | ✓included |
Each file is priced with the expert who will handle it, after the regulatory assessment. Turnkey or task by task, the quote is itemised line by line.
The AMMPS and the ONSSA remain the sole judges of your file. We promise neither a decision nor a time frame: we bring you a file prepared by experts in the field.
An authorisation relies on a solid quality system. If yours needs to be built or upgraded, our quality services take over within the same project.
After authorisation, we can handle regulatory watch, renewals and the organisation of product recalls, always in the name of the holder.
Start with the online assessment or speak directly to a regulatory expert.