Morocco Medical Device Registration: 20 FAQs on AMMPS, Certificate Holders and Dossiers (2026)

Morocco is one of the most underestimated medical device markets in North Africa, and one of the markets where companies most often misjudge using European experience. The real barrier is not the CE certificate, but three things: who holds the registration certificate, who signs the dossier, and how changes and vigilance are maintained. The following 20 questions and answers are based on the current text of Moroccan regulations and the current AMMPS (Moroccan Agency for Medicines and Health Products) acceptance checklists, with article numbers and checklist versions cited so each item can be verified.

I. Regulatory Framework and Who Holds the Certificate

Q1. Who regulates medical devices in Morocco, and how many tiers does the regulatory system have?

The competent authority is the Moroccan Agency for Medicines and Health Products (AMMPS), established under Law No. 10-22 (Dahir No. 1-23-54 of July 12, 2023), which took over the functions of the former Directorate of Pharmacy and Medicines (DMP). The system has four tiers:

1. Law – Law No. 84-12 on medical devices (Dahir No. 1-13-90 of August 30, 2013; Official Bulletin No. 6188 of September 19, 2013).
2. Decree – Decree No. 2-14-607 for the application of the law (September 18, 2014; Official Bulletin No. 6292 bis of September 19, 2014).
3. Ministerial orders – Orders Nos. 2853-15, 2854-15, 2855-15 and 2856-15 of August 4, 2015.
4. Operational documents – current AMMPS checklists and forms (each bearing a number, version and effective date).

Tip: older ministerial order texts still refer to the Directorate of Pharmacy and Medicines. To judge whether a document is current, look at the issuing authority and the checklist version, not the letterhead.

Q2. Who receives the registration certificate? Can a foreign manufacturer hold it itself?

No. Article 12 of Law No. 84-12 provides that placing a device on the market requires a prior registration certificate; the certificate is issued, upon application, to any manufacturing or importing establishment for medical devices duly declared under Article 7, after an opinion from the National Advisory Committee for Medical Devices (Article 36).

This means the applicant and the responsible party are both establishments located in Morocco, not the foreign manufacturer. Article 16 places the duties of continuously evaluating clinical data and notifying changes in writing directly on the certificate holder; risk measures under Article 26 and recalls under Article 29 are likewise carried out by the certificate holder.

Conclusion: choosing a certificate holder is not choosing an address that can sign; it is choosing who will bear a set of legal responsibilities.

Q3. Does Morocco have an EU-style authorized representative?

There is no such independent legal status. Morocco does not maintain a register of authorized representatives; the substitute mechanism has two layers:

1. The local establishment must first complete the establishment declaration under Article 7 before it is eligible to submit a product registration.
2. The manufacturer provides a certificate of affiliation – a document issued by the manufacturing establishment or its mandated party describing the relationship between the manufacturer and the applicant establishment, in original or certified copy (item 3 of the registration checklist).

In addition, all administrative documents in the registration dossier must be dated, signed and stamped by the legal representative of the Moroccan establishment (footer note of the registration checklist).

Practical implication: it is not a matter of sending documents over to be stamped. The manufacturer supplies the content, and the local establishment supplies the signing authority. The seniority of the signatories on both sides should be fixed at project initiation.

Q4. What does the local establishment declaration require, and how long does it take?

Article 7 requires establishments that manufacture, import, export, distribute or maintain devices to declare before starting operations, with a supporting dossier. Article 8 gives the competent authority 90 days to request additional information, inspect the establishment and communicate required corrections; if no reply is received within 90 days, the declaration is deemed accepted.

The current establishment declaration checklist (DE RD-IS-PS/04, version 01, effective May 11, 2026) requires: the declaration form, floor plans signed and stamped by an architect or surveying engineer (basement levels must not be used for the declared activities), a staff list, an organization chart, a description of production and storage premises, a sworn statement on the accuracy of documents, proof of registration in the commercial register (Model 7), proof of identity of the legal entity, articles of association stating the declared scope of business, and the resolution appointing the legal representative.

Changes: Article 2 of Decree No. 2-14-607 requires a new declaration within one month of any change.

Note the sequence: the establishment declaration receipt is a mandatory item of the product registration dossier (item 17 of the registration checklist). First the establishment, then the product.

II. Classification, Exemptions and IVDs

Q5. How does Morocco classify devices, and how many classes are there?

Article 4 of Law No. 84-12 classifies devices by duration of use, invasiveness, surgical use, active status, and whether they act on vital organs (circulatory system, central nervous system), into four classes: Class I (low potential risk), Class IIA (medium), Class IIB (higher) and Class III (critical), explicitly graded by degree of danger.

The current AMMPS registration checklist places two subclasses under Class I: Is (sterile) and Im (with a measuring function); the classification logic is consistent with the EU MDD.

Classification determines not only how much documentation is needed, but whether a foreign market approval, ISO 13485 or a design certificate is required (see Q9 and Q10).

Q6. Which devices do not need registration?

Article 13 lists six exemptions: (1) experimental devices used for biomedical research; (2) devices prescribed for a specific patient and not placed on the market in Morocco; (3) used devices imported for refurbishment and re-export; (4) custom-made devices; (5) samples used for registration evaluation; (6) samples displayed at trade fairs and scientific conferences (which must carry a conspicuous marking stating that they must not be marketed or put into use before registration).

Exemption does not mean exemption from oversight: these devices still require specific authorization from the competent authority; conditions and procedures are set by Article 8 of Decree No. 2-14-607, and AMMPS has published a dedicated checklist for each category. There is also an emergency channel – Article 21 allows the health authority to exceptionally approve marketing and use where public health requires it and the situation is urgent.

Q7. Do in vitro diagnostic devices (IVDs) follow the same process?

No. IVDs are governed by Law No. 11-08 on in vitro diagnostic devices and its implementing Decree No. 2-12-149, in parallel with Law No. 84-12. Article 2 of Law No. 10-22 places both under health products, but the registration route, dossier checklist and fee schedule are each independent.

The fee difference can be verified directly: under the current AMMPS fee schedule, the medical device registration certificate is MAD 1,000 (VAT included) and the IVD registration certificate is MAD 500.

Common mistake: treating IVDs as a category of medical devices and applying the device checklists. The first step of any project should be determining whether the product falls under Law 84-12 or Law 11-08.

III. Dossier, Evidence and Timelines

Q8. What exactly goes into the registration dossier?

The current registration checklist for medical devices (DE ER DM/01, version 9, effective January 30, 2025) contains 17 items:

1. Application letter (product name, trade name, medical value), x3 copies.
2. Summary sheet, x3 copies.
3. Manufacturer’s certificate of affiliation.
4. CE certificate, FDA document, marketing approval from the country of origin (CVL) or equivalent document.
5. ISO 13485 or equivalent certificate.
6. Manufacturer’s declaration of conformity with the essential requirements.
7. Draft labeling.
8. Draft instructions for use (if applicable).
9. Sales sample or prototype plus color photographs (exempt for medical equipment).
10. Technical documentation including the essential requirements compliance checklist.
11. Description of the medical equipment (Annex VI template).
12. User manual (equipment).
13. Technical documentation prepared under Article 5 of Order No. 2855-15 (equipment).
14. Color catalog (equipment and device families).
15. Evidence of good manufacturing practice.
16. Registration certificate form completed per Annex II of Order No. 2855-15.
17. Copy of the Moroccan establishment declaration receipt.

Submission format: three paper copies plus a CD-ROM (documents must be generated with the numbering clearly legible via the automated module provided by AMMPS) plus the payment receipt. Class-dependent applicability: item 4 applies to Classes IIA, IIB and III and to subclasses Is and Im of Class I; item 5 applies to Classes IIA, IIB and III; item 15 mainly applies to local manufacturing and semi-finished products.

Q9. How is foreign market approval used? Is a CE mark enough?

Item 4 follows a choose-one-of-three logic: a CE marking certificate, an FDA document, or a marketing approval (CVL) from the competent authority of the country of origin or an equivalent document – any one is acceptable, but it must correspond to the models declared.

Two easy-to-miss points: (1) for Class III, in addition to a CE quality system certificate, a CE design certificate is required, as stated in the registration checklist footnote; (2) if marks are affixed to samples, the corresponding certificates must be submitted with them.

A CE mark is not a passport. It is only one necessary support for registration and cannot replace the Moroccan registration certificate.

Q10. When is ISO 13485 mandatory?

Classes IIA, IIB and III must submit an ISO 13485 or equivalent certificate (item 5 of the checklist); Class I (including Is and Im) is not covered, but still requires the declaration of conformity (item 6) and the essential requirements compliance check (item 10).

Q11. How far do the clinical evidence requirements go?

Article 15 provides two alternative routes: (1) clinical trials conducted under current regulations; or (2) an evaluation of clinical data from the existing scientific literature, provided the applicant demonstrates a proven equivalence between the device declared and the device covered by that literature. The evaluation result must be included in the registration dossier (Article 15(3)).

There is a substantive relief clause for imported devices: the registration checklist footnote states that technical documentation for imported devices is not mandatory, but Class III devices must provide clinical data.

If clinical trials are to be conducted in Morocco, Law No. 28-13 on the protection of participants in biomedical research and the AMMPS accreditation rules for institutions also apply; AMMPS updated the requirements for accreditation of clinical trial sites by Decision No. 50/SDG/AMMPS/26 of February 25, 2026.

Q12. How long does the official review take?

Article 4 of Decree No. 2-14-607: the competent authority must decide within a maximum of 120 days from submission of a complete dossier; a rejection must state reasons and be notified to the applicant.

Everything hinges on the word complete: the 120 days is the administrative ceiling for the decision, not a promise to issue the certificate. The authority may request corrections during the review (AMMPS maintains a separate checklist for corrections). Project planning should use first acceptance plus one round of corrections as the baseline, rather than counting back from a launch date on the assumption of 120 days.

IV. Fees, Validity and Changes

Q13. How much does registration cost, and does pricing also need to be declared?

Government fees are low: MAD 1,000 per medical device registration certificate (VAT included) and MAD 500 for IVDs (current AMMPS fee schedule). The real costs lie in dossier engineering, translation, samples and the local certificate-holder arrangement.

Pricing is a separate track: Article 5 of Law No. 10-22 requires AMMPS to establish a framework for medical device prices and to receive declarations of sales prices from manufacturing or importing establishments; pricing of Class III devices is additionally governed by Order No. 4217-15 of 2015. Whether the price declaration must be completed at the same time as registration depends on the product class and the sales channel; confirm this at project initiation to avoid ending up with a certificate in hand but no approved price.

Q14. How long is the certificate valid, and what does renewal require?

Article 6 of Decree No. 2-14-607: the registration certificate is valid for 5 years and is renewable; for used and refurbished devices, the validity equals the remaining life of the device; where a certificate is renewed following changes or a change of holder, the validity carries over the remaining term of the original certificate.

The renewal checklist (DE ER DM/03, version 4, effective January 30, 2025) requires: application letter and summary sheet, 3 copies each; a copy of the current certificate; a sworn statement from the holder that the product has undergone no change (if there are changes, each must be described and justified); the manufacturer’s certificate of affiliation; a vigilance review of the device over the past 5 years issued by the manufacturing establishment; labeling; instructions for use; color photographs; a color catalog of the equipment and device families; plus paper copies, CD-ROM and the payment receipt.

The regulations do not state how early to file, but once the certificate expires the lawful basis for marketing is lost. Starting 6 months before expiry is recommended.

Q15. Model changes, added specifications, new labeling: update or new registration?

Start from the two checklists. Cases handled by certificate update (update checklist DE ER DM/02, version 4, categories A to R, 18 in total) include: trademark or trade name; holder name; name of the manufacturing establishment in the country of origin; adding or removing manufacturing sites; address of the Moroccan establishment; validity period or storage conditions; inner and outer packaging; mandatory information on labeling and instructions for use; adding or removing kit components; indications; CE notified body code; adding or removing model references; extension of dosage; extension of pack sizes; minor formulation changes, and so on.

Cases requiring a new registration: Article 16(2) provides that any change in the nature of the device requires a new application; the registration checklist footnote further lists – extension in the form of the device, changes to the composition of a kit or system due to added constituent elements, and changes in composition due to the addition of an active substance.

In short: adding or removing models and specifications is mostly an update; changes in form and composition require a new registration. Getting this judgment wrong means starting over from the beginning.

Q16. How does a change of certificate holder work, and what if the previous holder does not cooperate?

Article 17: a change of holder requires a certificate transfer authorization issued by the competent authority. The transfer checklist (DE ER DM/04, version 2) requires: the transferee’s application letter in 3 copies, 3 summary sheets, a copy of the valid certificate, an assignment agreement issued by the original holder, and the manufacturer’s certificate of affiliation (proof of GMP is additionally required for local manufacturing or semi-finished products).

Two institutional facts: (1) the assignment agreement must be issued by the original holder – without the previous holder’s signature, the transfer cannot begin; (2) after transfer, the certificate validity does not restart; only the remaining term carries over (Article 6(3) of Decree No. 2-14-607).

The holder agreement must therefore clearly state: term, exit and cooperation duties for the transfer, remedies for breach, and the boundary of certificate-follows-goods arrangements. If this clause is not negotiated well, the lifeline of the distribution channel is handed to the other party.

V. Post-Market, Advertising and Red Lines

Q17. How quickly must adverse events be reported, and how do risk measures proceed?

Article 23 requires traceability rules proportionate to the risk class; Article 25 requires manufacturing, importing, exporting and distributing establishments, as well as healthcare professionals using the devices, to report to the competent authority any adverse event, risk or quality defect known to them within 48 hours.

Article 26 sets the handling procedure: where the authority considers that a device may endanger public health, it notifies the holder, who must respond within a maximum of 15 days; on that basis it may order immediate cessation of distribution and a recall; in emergencies it may suspend the registration with reasons, with preventive withdrawal from the market within 15 days of suspension and a final decision within 60 days.

For foreign manufacturers: the reporting duty falls on the local certificate holder and the importing establishment. The contract must set time limits for passing information from manufacturer to holder; otherwise the 48-hour clock is already lost on day one.

Q18. Do scientific promotion, trade fairs and social media content need approval?

It depends on the audience. Article 31: only devices holding a registration certificate may be advertised. Article 34: advertising directed at the public requires a prior advertising visa; Article 14 of Decree No. 2-14-607 provides a decision within 60 days. Article 33 adds restrictions: devices available only on prescription or reimbursed, or whose certificate restricts public advertising, must not be advertised to the public. Article 35: promotion directed at professionals must be declared to the competent authority in advance with a copy of the promotional material; the authority may object within 30 days of receipt. Article 32: advertising must not be misleading and must be objective and consistent with the registration dossier.

The advertising checklist (DE ER DM/05, version 2) requires: application letter, summary sheet, copy of the valid certificate, samples of the promotional material, and the scientific documentation corresponding to the references cited in the material; for public advertising, a visa form per Annex III of Order No. 2855-15 is additionally required. Any change in the scientific data or dossier content requires a new visa application.

Practical reminder: trade fair samples, distributor-made brochures and social media content all fall within the scope of promotion.

Q19. Can used and refurbished equipment be imported?

In principle they cannot be imported freely. Article 18 provides that the age, list, class and nature of used and refurbished devices eligible for registration and marketing are determined by regulation; Article 7 of Decree No. 2-14-607 assigns the list to a decision of the Minister. Article 6 further provides that the registration certificate for such devices is valid for the remaining life of the device.

Ministerial Decision No. 630.26, published in March 2026, adjusted that list: registrable used models are limited to specific categories such as imaging and radiotherapy (CT, MRI, PET, SPECT, interventional imaging, external beam radiotherapy, brachytherapy, radiosurgery, among others), and require that the same model has already been registered in Morocco as new equipment, that the original quality, safety and performance standards are maintained, that the intended use is unchanged, and that the period of use does not exceed half of the service life stated by the manufacturer. The precise scope of application follows the text of the official bulletin and AMMPS acceptance practice.

There is also a separate, non-conflicting channel: under item 3 of Article 13, used devices imported for refurbishment and re-export are not subject to the registration obligation, but require specific authorization.

Q20. What is the cost of non-compliance?

Under Chapter V of Law No. 84-12, penalties are tied to the risk class:

In addition, courts may order confiscation and a 5 to 10 year ban on professional activity; where users are shown to face a risk of death, the ban is permanent (Article 48).

Combined with the inspection mechanism in Articles 38 to 40: problems found during inspection first trigger an order to correct within a set period; failing that, the case may be referred to the prosecutor, and where public health is endangered, the court may be asked to order closure of the establishment.

Closing note

Treat Morocco as a submit-documents-get-certificate market and you will stumble at four points: the certificate holder entity, signing authority, change classification and the 48-hour vigilance clock. Among the 20 questions, the ones that truly decide project success are Q2, Q3, Q15 and Q17 – none of them is a documentation problem; they are structural problems.

Appendix: list of regulatory sources

1. Law No. 84-12 on medical devices (Dahir No. 1-13-90 of August 30, 2013; Official Bulletin No. 6188 of September 19, 2013).
2. Decree No. 2-14-607 for the application of the law (September 18, 2014; Official Bulletin No. 6292 bis of September 19, 2014).
3. Ministerial Orders Nos. 2853-15, 2854-15, 2855-15 and 2856-15 of August 4, 2015.
4. Law No. 10-22 (Dahir No. 1-23-54 of July 12, 2023; Official Bulletin No. 7462 of December 4, 2025).
5. Law No. 11-08 on in vitro diagnostic devices; Decree No. 2-12-149 for its application.
6. Law No. 28-13 on biomedical research; AMMPS Decision No. 50/SDG/AMMPS/26 of February 25, 2026.
7. AMMPS checklists: DE ER DM/01 version 9 (2025-01-30), DE ER DM/02 version 4 (2025-01-30), DE ER DM/03 version 4 (2025-01-30), DE ER DM/04 version 2 (2025-01-30), DE ER DM/05 version 2 (2025-01-30), DE RD-IS-PS/04 version 01 (2026-05-11).
8. Current AMMPS fee schedule (medical device registration certificate MAD 1,000 each; IVD MAD 500 each).
9. Ministerial Decision No. 630.26 of March 2026 (list of used and refurbished devices).

Disclaimer: this article summarizes the regulatory texts and AMMPS checklists cited above for general information only and does not constitute legal or regulatory advice. Requirements, checklist versions and fees may change; always verify against the official texts published by AMMPS and the Moroccan authorities before making decisions.