Six Exemptions from Registration and the Specific Authorisation Requirement

1. Key takeaways

Article 13 of Law No. 84-12 lists six categories of devices that are exempt from the registration obligation: experimental devices used in biomedical research; devices not yet marketed in Morocco that are prescribed for specific patients; used devices imported for the purpose of refurbishment and export; custom-made devices; samples imported for the purposes of registration evaluation; and samples imported or locally manufactured for demonstration to professionals at exhibitions. However, the final paragraph of the provision makes clear that each of these categories still requires a specific authorisation (autorisation spécifique). The exemption from registration exempts the procedure of Article 12; it does not exempt the approval itself.

For companies, the distinction matters because the six categories are frequently mistaken for a free passage. In reality, each device must first be assigned to the correct category, and a separate authorisation file must then be built under the conditions and procedures laid down in the applicable regulation. Misclassification at the entry point is the most common cause of rejection.

A second structural point deserves emphasis: the specific authorisation is granted by the competent authority under conditions and procedures fixed in advance, which makes the exemption categories predictable in principle but demanding in practice. For each category, the applicant must show not only that the device falls within the category but also that the use envisaged respects the limits of that category, for example that evaluation samples are genuinely confined to evaluation, or that exhibition samples are genuinely confined to professional display. The authority therefore reviews both the classification and the intended operation, and a file that addresses only one of the two is incomplete. Companies planning sample programmes, custom-made production or refurbishment-for-export flows into Morocco should treat the specific authorisation as a project with its own dossier, timeline and evidence set, parallel to but distinct from the conventional registration of Article 12.

2. Legal basis

3. Expert insights

Insight 1: The six categories follow three distinct logics. The first and fifth categories serve research and evaluation (experimental research and samples imported for registration purposes); the second and fourth categories serve individualised needs (prescription for a specific patient and custom-made devices); the third and sixth categories serve circulation and demonstration (used devices imported for refurbishment and export, and exhibition samples). When applying for a specific authorisation, the argumentation must match the logic of the category concerned. A single template justification cannot be reused across the three logics without weakening the file.

Insight 2: The fifth category is a compliant entry point for low-cost testing of the market. Samples imported for the purposes of registration evaluation are exempt from registration, so companies can use this route to conduct local testing or clinical assessment before formally submitting a registration file. However, Article 44 expressly lists the placing on the market of samples imported for evaluation as an offence, punishable at 5% to 10% of turnover. The boundary between evaluation samples and commercial sales must be drawn firmly in internal procedures.

Insight 3: The sixth category carries a mandatory visible signage requirement. The provision requires that samples displayed to professionals at exhibitions, scientific congresses or fairs be accompanied by clearly visible signage stating that the device may not be placed on the market or put into use before registration is completed. This is the only one of the six categories that carries an on-site public notice obligation, and it is drafted as an obligation, not as a recommendation.

Insight 4: The third category positions Morocco as a refurbishment-for-export base. Used devices imported for the purpose of refurbishment and subsequent export are exempt from registration. This echoes Article 1, item 9, which brings devices imported for refurbishment within the definition of import sites. It is an industry-oriented channel, and it must not be confused with the separate pathway for devices refurbished and sold on the Moroccan local market, which is governed by Article 18.

Insight 5: The boundary of the second category is that the device is not yet marketed in Morocco. Once the device has been commercialised in Morocco, the specific-patient prescription route no longer applies and the conventional registration procedure must be followed. Companies should therefore check commercialisation status before relying on this route for any individual patient supply.

4. Practical recommendations

1. Classify first, apply second. Determine, item by item, which of the six categories the device belongs to, and organise the supporting materials around that category. Files submitted under the wrong category are returned directly.
2. Keep records across the full lifecycle of samples. For samples imported for evaluation or demonstration, maintain a ledger covering import, custody, use and return or destruction, demonstrating at every step that the samples were never placed on the market.
3. Prepare exhibition signage in advance. The signage must be clearly visible and state that the device may not be placed on the market or put into use before registration is completed. Printing it in French and Arabic is recommended for on-site acceptance.
4. Retain prescriptions for custom-made devices. Custom-made devices depend on a written prescription from a physician; retain each prescription individually and indicate that the device is intended solely for the specific patient concerned.
5. Check Annex I of Ministerial Order No. 2855-15. The concrete conditions and procedures for specific authorisations are set out in that annex; compare the application file against it point by point before submitting.

5. Verification checklist

• □ It has been determined which of the six categories of Article 13 the device belongs to
• □ It has been confirmed that the device is not excluded on the ground that it is already commercialised in Morocco
• □ The specific authorisation file has been prepared in accordance with Annex I of Ministerial Order No. 2855-15
• □ Compliant visible signage has been produced for exhibition samples
• □ Written physician prescriptions and patient correspondences have been retained for custom-made devices
• □ An import, use and disposal ledger has been established for evaluation samples
• □ Internal procedures expressly prohibit the transfer of samples into sales channels

GRZAN support for the Moroccan market. GRZAN helps manufacturers and distributors determine whether a product qualifies for one of the six exemptions of Article 13, prepares specific authorisation files under Ministerial Order No. 2855-15, and designs sample-management and custom-made-device procedures for Morocco. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026