Clinical Evaluation for Registration: Two Pathways under Article 15

1. Key takeaways

Article 15, first paragraph, of Law No. 84-12 sets a precondition for the grant of the registration certificate: a device submitted for registration must previously have gone through one of two pathways. The first is a clinical investigation (investigation clinique) conducted under the laws and regulations in force. The second is the evaluation of clinical data from available scientific literature, open only where the applicant can demonstrate a proven equivalence between the device submitted for registration and the devices to which the literature data relate. Both pathways must serve three verification purposes, and the results must be recorded in the registration file referred to in Article 14.

In other words, clinical evidence is not an optional annex to the Moroccan registration file; it is a statutory precondition to the certificate. The choice between the two pathways should be made early, because it determines the shape of the dossier, the timeline and the level of evidence the company must assemble before submission.

2. Legal basis

3. Expert insights

Insight 1: The three purposes of the second paragraph constitute the evaluation standard. The provision requires that the clinical investigation or the evaluation of clinical data make it possible, first, to assess the performance of the device under the conditions of its normal use; secondly, to assess the benefit-risk comparison and determine the undesirable side effects of the device; and thirdly, to confirm that the device satisfies the essential requirements set out in Article 5. These three purposes function both as the evidentiary objectives of the applicant and as the review checklist of the competent authority. Companies should structure their materials so that each of the three is answered expressly and separately.

Insight 2: The equivalence pathway hinges on proven equivalence (équivalence prouvée). The statutory wording uses demonstrate rather than claim, and the equivalence must be established against the devices to which the literature data relate. Merely asserting that a competitor product is of the same type is not sufficient: a point-by-point comparison of technical characteristics, biological characteristics and clinical characteristics must be built. GRZAN recommends presenting the equivalence comparison as a standalone table within the registration file, so that reviewers can trace each claim back to its literature source.

Insight 3: Article 16 turns clinical evaluation into a continuing obligation. Article 15 is a one-time precondition before the certificate; Article 16, by contrast, requires the certificate holder to evaluate continuously the clinical data for its products, updating them as scientific data evolve, and to notify in writing any change affecting those data or the content of the registration file. Clinical evaluation in Morocco therefore spans the entire lifecycle of the product, not merely the moment of first market access.

Insight 4: The choice of pathway correlates with the risk class. The practical situation verified by GRZAN is that the current registration list administered by AMMPS does not require a full technical file for imported devices, and clinical data requirements concentrate on Class III products (see article 28). Class IIA and IIB devices therefore mostly proceed through the literature equivalence pathway, while Class III devices need more complete clinical evidence. This tiering is a practical estimate and must be checked against the list in force at the time of submission.

Insight 5: A local clinical investigation engages another law. Where a clinical investigation must be conducted on Moroccan territory, the subject-protection rules of Law No. 28-13 on biomedical research involving human subjects apply. This connects directly with the wording of Article 15, first paragraph, item 1, which requires the investigation to be conducted under the laws and regulations in force.

Read together, the two pathways and the continuing obligation of Article 16 form a coherent evidence architecture. Before the certificate, the applicant must show performance, benefit-risk and essential requirements compliance through one of the two statutory routes. After the certificate, the holder must keep that same body of clinical data current and notify any change that affects it. The practical implication for dossier planning is that the work done for Article 15 should be organised in a way that survives into post-market maintenance: a literature equivalence argument built as a traceable table, and an investigation conclusion structured around the three statutory purposes, can both be updated annually without being rebuilt. Companies that plan the file in this way convert a one-time registration hurdle into a manageable lifecycle process, and reduce the risk that later scientific developments trigger unexpected notification obligations.

4. Practical recommendations

1. Assess the feasibility of the equivalence pathway first. For products with a well-characterised comparator device, building the equivalence argument early can shorten preparation significantly compared with a clinical investigation.
2. Make the equivalence table a standalone document. List technical, biological and clinical characteristics item by item, and cite traceable literature sources for the comparator device.
3. Organise the conclusions around the three statutory purposes. Write performance, benefit-risk comparison and essential requirements compliance as three distinct sections, so that the review can map directly onto Article 15.
4. Build clinical evaluation into annual maintenance. Set an annual review milestone under Article 16, and notify the authority in writing whenever scientific data change in a way that affects the file.
5. Plan clinical evidence early for Class III. If the product is Class III, prepare a complete clinical evidence package and schedule it accordingly, rather than following a Class II rhythm.

5. Verification checklist

• □ It has been decided whether to proceed by clinical investigation or by literature equivalence
• □ The equivalence argument covers technical, biological and clinical characteristics
• □ Literature sources for the comparator device have been listed and are traceable
• □ The evaluation conclusions are organised around performance, benefit-risk comparison and essential requirements
• □ The results of the evaluation have been recorded in the registration file referred to in Article 14
• □ An annual clinical data review mechanism under Article 16 has been established
• □ Where a local clinical investigation is involved, the requirements of Law No. 28-13 have been checked

GRZAN support for the Moroccan market. GRZAN supports manufacturers in selecting the appropriate clinical pathway for Morocco, preparing proven-equivalence arguments and literature packages, and aligning clinical evaluation files with Articles 15 and 16 of Law No. 84-12. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026