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AMMPS · structured requirements

🇲🇦 Morocco medical device regulatory data

Explore the medical device requirements currently available for Morocco, organized by topic and linked to official sources.

41 facts24 dimensions9 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Only registered devices may be advertised; advertising is subject to a prior visa

advertising.only-registered-devices-and-prior-visa
Fact-level verified

Only medical devices holding a registration certificate may be advertised to the public. Advertising must not be misleading or harm the protection of human health; it must present the device objectively, encourage its proper use, and conform to the registration dossier. All information in the advertising must be exact, up to date, conforming to the legislation in force, verifiable and sufficiently complete to inform the recipient correctly about the real performance of the device. Labelling and instructions for use are outside the definition of advertising.

Conditions
  • The advertising visa application is addressed to the Minister of Health (décret 2-14-607 art. 14, applying loi 84-12 art. 34); the AMMPS publishes a dedicated advertising checklist.

French original. Translation: 'Only medical devices benefiting from a registration certificate with the administration may be advertised.' Art. 34 provides that the advertising visa application is addressed to the Minister of Health, and décret 2-14-607 art. 14 repeats it.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Registration certificate valid five years, renewable

validity.registration-certificate-five-years
Fact-level verified

The device registration certificate is valid for a renewable period of five years, under conditions fixed by order of the Minister of Health. For used or refurbished devices, validity is limited to the remaining service life of the device. Where the certificate is updated after notification of changes to its particulars or to the dossier, or where the registration holder changes, it is valid only for the remaining term of the registration in progress.

Conditions
  • Renewal conditions are fixed by arrêté of the Minister of Health; no renewal checklist amount or window was evidenced in this round.

French original. Translation: 'The registration certificate is valid for a renewable period of five years under the conditions fixed by order of the Minister of Health.'

Renewal requires a manufacturer-issued five-year materiovigilance review and a no-change declaration

validity.renewal-dossier-and-five-year-vigilance-review
Fact-level verified

A renewal application must carry, for all risk classes and all devices, administrative items (application in triplicate, copy of the fee receipt, fiche signalétique in triplicate with an electronic copy, copy of the previous registration certificate, and a sworn declaration by the registration holder that the product has undergone no change — with any change stated and justified; plus, for imported and semi-finished imported devices, the manufacturer's or agent's attestation evidencing the link to the applicant) and technical items, of which the first is a materiovigilance review covering the last five years issued by the manufacturing establishment, together with the draft labelling and, where applicable, the draft instructions for use.

Conditions
  • The five-year vigilance review must be issued by the MANUFACTURING establishment, not by the Moroccan holder.
  • A change since the last registration does not bar renewal but must be specified and justified in the sworn declaration.
  • The AMMPS publishes a separate renewal checklist (Réf. DE ER DM/03, Éd. 04, 30/01/2025) restating the vigilance-review item.

French original. Translation: 'The renewal application for the registration certificate must be accompanied by a dossier comprising, for all risk classes and all medical devices, the following administrative and technical items: … b) Technical items: a materiovigilance review of the last 5 years, issued by the manufacturing establishment'. Bulletin officiel n° 6396 du 3 hija 1436 (17-9-2015), p. 3484. The document published by the Ministry under this filename is a 17-page scan of the four arrêtés of 4 August 2015 with no text layer; the passage was read by OCR of the official scanned Bulletin officiel pages at 200 dpi with Tesseract (fra), and the five-year vigilance item is independently reproduced in the AMMPS renewal checklist's clean text layer.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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AMMPS holds the operational device competences; the registration certificate issues in the name of the administration

authority.ammps-device-competence
Fact-level verified

Medical devices are 'produits de santé' for the purposes of loi 10-22, which expressly includes 'les dispositifs médicaux au sens de la loi n° 84-12'. The Agence Marocaine du Médicament et des Produits de Santé (AMMPS), a public establishment under the Ministry of Health and Social Protection, is charged with the device competences: receiving the declarations of establishments that manufacture, import, export, distribute or maintain medical devices; setting the framework for device prices and receiving their declared sale prices; supervising inspection of those establishments; and vigilance in the field of medicines and health products. Under loi 84-12 art. 12 the registration certificate itself is issued by 'l'administration', which décret 2-14-607 art. 24 defines as the Minister of Health.

Conditions
  • Loi 10-22 was promulgated by dahir n° 1-23-54 of 12 July 2023; the Direction du Médicament et de la Pharmacie (DMP) staff and structures transfer to the agency.
  • Operationally the AMMPS issues the device dossier forms and checklists, hosts the DES-DM electronic filing module, and receives the applications.

French original of the device lines of Art. 5, 2°: '– la déclaration relative aux établissements de fabrication, d'importation, d'exportation, de distribution et de maintenance des dispositifs médicaux ;' and '– l'autorisation de réalisation des essais cliniques et des investigations cliniques'. Art. 2 defines produits de santé as including 'les dispositifs médicaux au sens de la loi n° 84-12 relative aux dispositifs médicaux'. Translation: the Agency is responsible for delivering the administrative documents and receiving the declarations, including the declaration relating to establishments that manufacture, import, export, distribute and maintain medical devices.

Registration is granted after consultation of the national consultative medical-device commission

authority.registration-consultative-commission
Fact-level verified

The registration certificate for a medical device is delivered by the administration after consultation of the 'commission nationale consultative des dispositifs médicaux'; the same commission is consulted before the administration orders a cessation of distribution or a recall, and before a definitive withdrawal from the market.

Conditions
  • The composition and rules of the commission are fixed by loi 84-12 art. 36 and its implementing texts.

French original. Translation: 'Placing a medical device on the market is subject to obtaining beforehand a registration certificate delivered by the administration, after consultation of the national consultative medical-device commission provided for in Article 36 below.'

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Dossier changes notified in writing; a change in the nature of the device requires a fresh registration

change.notification-and-new-registration
Fact-level verified

The registration holder remains responsible for the ongoing evaluation of the clinical data of its products as scientific knowledge evolves and must notify the administration in writing of any modification affecting those data or the content of the registration dossier of a device placed on the market. A new registration application must be filed for any change bearing on the nature of the medical device. Separately, the AMMPS checklist names three changes that trigger a new registration application: extension of the device's form, change in the composition of a kit or system on adding an element, and change of composition on adding an active substance. Change of the registration holder requires a transfer authorisation.

Conditions
  • Establishment-level changes are handled separately: any modification to the elements of the initial establishment declaration requires a new declaration within one month (décret 2-14-607 art. 2).
  • The AMMPS publishes dedicated checklists for updating, rectifying and transferring a registration certificate.

French original. Translation: 'The registration holder remains responsible for the permanent evaluation of the clinical data of its products according to the evolution of scientific data, and must notify the administration in writing of any modification affecting those data or the content of the registration dossier of a medical device placed on the market. A new registration application must be presented to the administration for any change bearing on the nature of the medical device.'

Post-registration update decided within a maximum of 20 days; notification letter in triplicate

change.update-decision-20-days
Fact-level verified

The administration decides on an application to update a device registration certificate within a maximum of twenty days from the date the complete dossier is filed; any refusal must be justified and communicated to the establishment concerned. The update may be recorded on the back of the original registration certificate. The notification letter for modifications must be drawn up in triplicate, signed and stamped by the legal representative of the establishment concerned, accompanied by a fiche signalétique in triplicate with its electronic copy, a copy of the registration certificate in force, and the documents justifying the change.

Conditions
  • This 20-day clock is the update/modification clock; the 120-day clock applies only to a first registration application.
  • The update route is distinct from a fresh registration application, which is required where the change bears on the nature of the device (loi 84-12 art. 16).

French original. Translation: 'The application for an update is decided within a maximum period of 20 days from the date of filing of the complete dossier. Any refusal must be justified and communicated to the establishment concerned.' Bulletin officiel n° 6396, p. 3485. Read by OCR of the official scanned Bulletin officiel pages; art. 10 sets the notification-letter contents.

Classification rules

What local class follows from which rules and decisive product facts?

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Four risk classes (I, IIA, IIB, III) set by statute; sub-classes Is and Im applied in the dossier

classification.four-risk-classes
Fact-level verified

Devices are classified by degree of danger: class I (low potential risk), class IIA (moderate), class IIB (high), class III (critical). The classification criteria are duration of use, invasiveness, intended purpose (surgical or not), active or non-active character, and whether a vital part of the body is involved. The AMMPS registration dossier additionally applies the sub-classes Is (sterile) and Im (with a measuring function) of class I, and a separate column for devices emitting ionising radiation.

Conditions
  • The classification rules themselves are fixed by arrêté n° 2856-15 of 4 August 2015 under décret 2-14-607 art. 9.

French original. Translation: 'Medical devices are classified according to their degree of danger as follows: class I: low potential risk; class II A: moderate potential risk; class II B: high potential risk; class III: critical potential risk.' The Is/Im sub-classes are taken from the AMMPS registration checklist, which lists 'Classe I', 'Classe Is', 'Classe Im', 'Classe IIA', 'Classe IIB', 'Classe III'.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Registration requires a prior clinical investigation or a literature-based clinical evaluation with proven equivalence

clinical.evidence-required-before-registration
Fact-level verified

The registration certificate may be issued only if the device has first been the subject of either a clinical investigation carried out under the legislation in force, or an evaluation of clinical data through the available scientific literature where the applicant proves a demonstrated equivalence between the device applied for and the device to which those data relate. The investigation or evaluation must allow the device's performance under normal conditions of use to be assessed, the benefit-risk ratio to be evaluated and adverse effects determined, and conformity with the essential requirements to be confirmed. The results must appear in the registration dossier.

Conditions
  • Clinical investigations are authorised by the AMMPS under loi 10-22 art. 5, 2°, subject to the legislation on protection of persons participating in biomedical research (loi n° 28-13).

French original. Translation: 'The registration certificate may be delivered only if the medical device that is the subject of the registration application has first been the subject of: 1 - either a clinical investigation carried out in accordance with the legislation and regulation in force; 2 - or an evaluation of clinical data through the available scientific literature, where the registration applicant proves a demonstrated equivalence of the device that is the subject of the application with the device to which those data relate.'

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Statutory device definition based on intended medical purpose and non-pharmacological principal action

scope.device-definition
Fact-level verified

A medical device is any instrument, apparatus, equipment, material, product or other article used alone or in combination, including accessories and software involved in its operation, intended by the manufacturer to be used in humans for medical or surgical purposes, and whose principal intended action is not obtained by pharmacological, immunological or metabolic means, although its function may be assisted by such means. Active implantable devices and accessories are separately defined; products that form an integral, non-reusable unit with a medicine are medicines, not devices.

Conditions
  • Devices made from non-viable animal or human tissue are devices provided they meet the essential requirements.
  • In-vitro diagnostic reagents are excluded — they are governed by loi n° 11-08.

French original. Translation: '1) Medical device: any instrument, apparatus, equipment, material, product, or other article used alone or in combination, including the accessories and software involved in its operation, intended by the manufacturer to be used in humans for medical or surgical purposes and whose principal action intended by this medical device is not obtained by pharmacological or immunological means nor by metabolism, but whose function may be assisted by such means'.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Seventeen-item paper dossier plus electronic copy generated by the AMMPS DES-DM module

dossier.registration-dossier-items
Fact-level verified

The registration dossier is a fixed 17-item paper file: application letter in triplicate; fiche signalétique in triplicate; manufacturer's attestation evidencing the manufacturer–applicant link; the origin-country CE/FDA/CVL certificate; ISO 13485 certificate for classes IIA, IIB and III; the manufacturer's declaration of conformity to the essential requirements; draft labelling; draft instructions for use where applicable; a sale-model sample or prototype with colour photographs; technical documentation with a conformity checklist and the standards relied on; a descriptive note for medical equipment; the instructions for use or user manual; technical documentation under art. 5 of arrêté 2855-15 for medical equipment; a colour catalogue; the GMP certificate issued by the Direction du Médicament et de la Pharmacie; the completed registration-certificate model (Annex II of arrêté 2855-15); and a copy of the declaration attestation of the Moroccan establishment. An electronic copy is also filed, with files generated by the automated module supplied by the AMMPS.

Conditions
  • A payment receipt (quittance) for the registration fees must be obtained from the régie.
  • All items must be dated, signed and stamped by the legal representative of the Moroccan establishment.
  • A new registration application is required for extension of the device's form, change in the composition of a kit or system on adding an element, and change of composition on adding an active substance.

French original of item 13, which is the provision that makes arrêté 2855-15 the legal anchor of the dossier: '13- Documentation technique conformément aux dispositions de l'article 5 de l'arrêté N°2855-15(³) ;'. Translation: 'Technical documentation in accordance with the provisions of Article 5 of Order No. 2855-15'. Checklist Réf. DE ER DM/01, édition 9, date d'application 30/01/2025.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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The Moroccan 'certificat de libre vente' is an OUTBOUND export certificate, not an inbound import requirement

roles.export-free-sale-certificate
Fact-level verified

In Moroccan law a 'certificat de libre vente' for medical devices is a document the administration issues TO an export establishment, attesting that the devices concerned conform to the good-manufacturing rules of loi 84-12. It is granted to an establishment that exports new, refurbished or used devices, and the arrêté adds it to the dossier of a locally manufactured device only where that device will also be exported. A foreign manufacturer seeking Moroccan registration does not obtain or file a Moroccan certificat de libre vente; the inbound document it files is the origin-country certificate under dossier item 4.

Conditions
  • Do not conflate this with the origin-country 'certificat de vente libre / CVL' accepted under dossier item 4, which is issued by the FOREIGN competent authority.
  • The export establishment is defined in loi 84-12 art. 1, 10) and is one of the establishment categories that must be declared under art. 7.

French original. Translation: 'The free-sale certificate referred to in Article 1 (point 10) of law n° 84-12 on medical devices, which is issued by the Direction du Médicament et de la Pharmacie, where the medical device concerned will also be the subject of an export.' Loi 84-12 art. 1, 10) defines the export establishment as one that exports devices 'subject to obtaining from the administration a free-sale certificate attesting that the medical devices concerned conform to the rules of good manufacturing practice'. Both passages read directly (loi 84-12 from the AMMPS-hosted clean-text PDF; arrêté 2855-15 by OCR of the official scanned Bulletin officiel pages).

The registration applicant must be a declared Moroccan manufacturing or importing establishment

roles.registration-holder-is-declared-moroccan-establishment
Fact-level verified

The registration certificate is granted only to a manufacturing or importing establishment that has been declared to the administration in Morocco. A foreign manufacturer cannot hold the Moroccan registration directly; the registration holder is the Moroccan establishment, and only that establishment's legal representative signs and stamps the dossier. The dossier must also contain an attestation from the manufacturing establishment or its agent evidencing the link between the manufacturer and the applicant establishment.

Conditions
  • Every document in the dossier must be dated, signed and stamped by the legal representative of the Moroccan establishment (checklist NB).
  • Change of the registration holder requires a transfer authorisation from the administration (loi 84-12 art. 17; décret 2-14-607 art. 5).

French original quoted in the locator article; see also the AMMPS checklist item 3 ('Attestation de l'établissement de fabrication ou de son mandataire démontrant le lien entre le fabricant et l'établissement demandeur') and item 17 ('Copie de l'attestation de déclaration de l'établissement marocain'). Translation of art. 12: the certificate is granted to any manufacturing or importing establishment duly declared to the administration.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Manufacturing, import, export, distribution and maintenance establishments must be declared with a full technical file

establishment.declaration-with-architectural-and-personnel-file
Fact-level verified

Any establishment manufacturing, importing, exporting, distributing or maintaining medical devices must be declared to the administration before starting activity. The declaration file must contain architectural plans and technical installation drawings conforming to good manufacturing, transport, storage and distribution practice; the list and qualifications of staff by function and post; an organisation chart dated and signed by the legal representative; a note indicating manufacturing and/or storage sites outside the establishment site and any delegated operations; company documents (commercial-register entry, articles of association, appointment of the legal representative); and the name of the person responsible for materiovigilance within the establishment. Four copies are filed with the Direction du Médicament et de la Pharmacie, one of them electronic.

Conditions
  • Declaration is a precondition of the device registration application (loi 84-12 art. 12).
  • Any change to the elements of the initial declaration requires a fresh declaration within one month (décret 2-14-607 art. 2).

French original. Translation of Art. 3: 'The declaration must be filed with the Direction du Médicament et de la Pharmacie in four (4) copies, one of them in electronic form.' The document is a scan of Bulletin officiel n° 6396 (17-9-2015), p. 3479; text read via OCR of the official scanned edition.

Fees

What regulator fee applies to this class, route, event, and date?

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Medical-device registration certificate fee is 1 000 DH (IVD 500 DH)

fees.device-registration-certificate-1000-dh
Fact-level verified

The AMMPS tariff schedule published by the agency fixes the fee for a medical-device registration certificate at 1 000 dirhams TTC, and for an in-vitro diagnostic reagent registration certificate at 500 DH. The schedule is validated by the AMMPS Conseil d'Administration and all amounts are expressed in Moroccan dirhams TTC. These are certificate-issuance fees, separate from the class III device price-and-margin regulation and from any additional technical-evaluation fee.

Conditions
  • A copy of the quittance for the registration fees must be filed with the dossier; the checklist directs applicants to obtain it from the régie.
  • The same schedule lists a declaration of a medical device at the device/DMDIV declaration line and separate amounts for variations and renewals in the AMMPS device checklists; only the certificate figure is quoted here.
  • The historical arrêté conjoint n° 783-06 of 24 April 2006 also fixed 1 000 DH for a device registration certificate, but its IVD figure (1 500 DH) is superseded and it predates loi 84-12, so it should not be cited as the current schedule.

French original. Translation: 'Below is the list of services offered by the AMMPS together with the tariffs applicable to them, expressed in Moroccan dirhams (DH) including tax.' / 'Registration certificate for an in-vitro diagnostic reagent | 500 DH' / 'Registration certificate for a medical device | 1 000 DH'. Fee dimensions are on the 12-month re-verification cadence.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Labels of imported devices must add the importer's name and address and the registration-certificate number and date to the manufacturer's particulars

label.imported-device-label-adds-importer-and-registration-certificate-number
Fact-level verified

Point 13.3 of the essential requirements lists the mandatory label indications. Item a) requires the name or company name and address of the manufacturing establishment and, for medical devices imported for distribution, that the labelling, the outer packaging and/or the instructions for use additionally contain the name and address of the importing establishment and the number and date of the registration certificate, as the case may be. The other items are: the indications strictly necessary to identify the device and the package contents; 'STÉRILE' where applicable; lot code preceded by 'LOT' or serial number; the use-by date expressed by year and month; single-use indication; 'dispositif sur mesure'; 'exclusivement pour investigations cliniques'; special storage/handling conditions; special instructions for use; warnings and precautions; year of manufacture for active devices not covered by the use-by date; and the sterilisation method.

Conditions
  • The label content list mirrors the EU directive 93/42/EEC annex I point 13.3 with the Moroccan importer/registration addition.

Effective from 2016-02-01

French original; items e) to m) elided in the excerpt and summarised in the value. The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Every package must contain an instruction notice, except class I and IIA devices usable safely without one; symbols and identification colours must follow harmonised standards

label.instruction-notice-in-every-package-except-class-i-iia-symbols-per-harmonised-standards
Fact-level verified

Under point 13.1 each device must be accompanied by the information needed to use it safely and identify the manufacturer, taking account of users' training; the package of each device must contain an instruction notice, with an exception for class I and IIA devices if they can be used safely without such instructions. Under point 13.2 the information should where appropriate take the form of symbols, and any symbol or identification colour must conform to the harmonised standards; where no standard exists, symbols and colours must be described in the documentation supplied with the device.

Conditions
  • Point 13.6 lists the notice contents (installation, maintenance and calibration, reuse and re-sterilisation, radiation, medicinal substances, accuracy of measuring devices, year of CE marking for CE-marked devices, date of last update of the notice).

Effective from 2016-02-01

French original. The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Notice and label languages: French and Arabic (minimum) for locally manufactured devices; English and/or French and/or Arabic for imported professional-use devices; French and/or Arabic for imported public-use devices

label.languages-french-and-arabic-min-manufactured-english-french-or-arabic-imported-professional
Fact-level verified

Point 14 of the essential requirements (annex II to arrêté 2856-15) fixes the languages of the instruction notice and the labelling of medical devices: for locally manufactured products, French and Arabic at minimum; for imported products for professional use, English and/or French and/or Arabic at minimum; for imported products intended for the general public, French and/or Arabic at minimum.

Conditions
  • Applies to devices under loi 84-12; in vitro diagnostic reagents follow their own regime.
  • Symbols of harmonised standards may be used to avoid multilingual translation of label information (point 13.5, last paragraph).

Effective from 2016-02-01

French original. Translation: 'The languages used for the notice and labelling of medical devices are: for manufactured products, French and Arabic (at minimum); for imported products: for professional use, English and/or French and/or Arabic (at minimum); intended for the general public, French and/or Arabic (at minimum).' This supersedes the existing partial fact stating that no device-specific language rule exists: the rule sits in arrêté 2856-15, which entered into application on 1 February 2016 (art. 5). The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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The manufacturing establishment must produce a materiovigilance review covering the last five years for every renewal, whatever the risk class

pms.manufacturer-five-year-materiovigilance-review-required-at-renewal
Fact-level verified

For the renewal of a registration certificate the technical part of the file must contain, for all risk classes and all devices, a materiovigilance review of the last five years issued by the manufacturing establishment, together with the draft label and, where applicable, the draft instructions for use. The manufacturer must therefore maintain a five-yearly post-market vigilance record for each registered device.

Conditions
  • Same passage as the existing approval-validity-renewal fact; recorded here for the manufacturer's standing PMS duty it implies.

Effective from 2016-02-01

French original. Translation: 'b) Technical items: a materiovigilance review of the last 5 years, issued by the manufacturing establishment.' The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Declared establishments and their subcontractors must follow good practices of performance evaluation of devices, defined as NM ISO 13485

pms.performance-evaluation-good-practices-binding-on-establishments
Fact-level verified

Article 11 of loi 84-12 obliges manufacturing, importing, exporting and distribution establishments and their delegatees to comply with the rules of good practice for manufacture, transport, storage, distribution and 'évaluation de la performance' of medical devices fixed by regulation; arrêté 2856-15 article 3 fixes those rules as the Moroccan standard NM ISO 13485 in force. A subcontracting delegatee must give an undertaking to comply with the same good practices (arrêté 2854-15 art. 1).

Conditions
  • Non-compliance with the good practices is an offence under loi art. 43.

Effective from 2013-09-19

French original. Translation: 'The establishments referred to in article 7 and their delegatees must comply with the rules of good practice for the manufacture, transport, storage, distribution and performance evaluation of medical devices, fixed by regulation after consultation of the representative bodies of the health professionals concerned.' The NM ISO 13485 designation is arrêté 2856-15 art. 3 (recorded under standards-testing-ancillary).

The registration holder remains responsible for the permanent evaluation of the clinical data of its devices as scientific knowledge evolves

pms.registration-holder-permanent-clinical-data-evaluation
Fact-level verified

Article 16 of loi 84-12 makes the registration holder responsible for the ongoing (permanent) evaluation of the clinical data of its products in line with the evolution of scientific data, with a duty to report in writing to the administration any modification affecting those data or the content of the registration dossier of a device placed on the market.

Conditions
  • The notification/new-registration consequence of the same article is already recorded under change-control; this fact records the standing post-market duty itself.
  • Failure to report is fined under art. 43 (200,000–500,000 MAD for classes I/IIA; 2–5 % of turnover for IIB/III).

Effective from 2013-09-19

French original. Translation: 'The registration holder remains responsible for the permanent evaluation of the clinical data of its products according to the evolution of scientific data, and must report in writing to the administration any modification affecting these data or the content of the registration dossier of a medical device placed on the market.'

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Inspections by at least two sworn inspectors, one of them a pharmacist inspector

inspection.sworn-inspectors-and-report
Fact-level verified

Inspection is carried out on the order of the Minister of Health by at least two inspectors, at least one of whom must be a pharmacist inspector. Inspectors take an oath before the court of first instance and are bound by professional secrecy; they carry a professional card issued by the Minister. They draw up a report after each inspection, or a procès-verbal of findings where an offence is punishable by law, and the report is transmitted to the Minister within seven days; a copy goes to the legal representative of the establishment concerned.

Conditions
  • Sampling and seizure of medical devices follow loi n° 13-83 on the suppression of fraud in goods.
  • The AMMPS supervises inspection of manufacturing, import, export, distribution and maintenance establishments (loi 10-22 art. 5, 3°).
  • A GMP certificate issued by the Direction du Médicament et de la Pharmacie is a mandatory registration dossier item.

French original. Translation: 'The inspection takes place, on the order of the Minister of Health, by at least two inspectors, one of whom must be a pharmacist inspector.' The seven-day transmission rule is at art. 23.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Administration may order cessation of distribution and recall; urgent suspension with 60-day limit

recall.administration-ordered-recall-and-suspension
Fact-level verified

Where it appears to the administration that a device may present risks to public health, it immediately notifies the registration holder and invites observations within fifteen days. On the holder's response, or in default of a response within that period, the administration may, after consulting the national consultative medical-device commission, order the holder to cease distribution immediately and to recall the devices placed on the market. In an emergency it suspends the registration by reasoned decision and orders preventive withdrawal from the market for fifteen days from the date of suspension until a final decision, which must be taken under the same procedure within sixty days of the suspension. A device may also be permanently withdrawn from the market by decision of the administration on the reasoned request of the registration holder.

Conditions
  • Devices destined for destruction or refurbishment outside the national territory must be recorded and the administration supplied with documents proving those operations were carried out (art. 29).

French original. Translation: 'When it appears to the administration that a medical device may present risks for public health, it immediately notifies the registration holder of the said device, inviting it to present its observations within a period not exceeding fifteen (15) days. In the light of the holder's response, or in the absence of a response within the aforementioned period, the administration may, after consultation of the national consultative medical-device commission, order the registration holder to cease distribution of the medical device immediately and to recall the medical devices placed on the market.'

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Single national registration certificate required before placing a device on the market

registration.certificate-before-marketing
Fact-level verified

Placing a medical device on the Moroccan market requires a prior registration certificate (certificat d'enregistrement). The application is filed with the AMMPS/Ministry of Health by a manufacturing or importing establishment that has itself been declared to the administration. There is no separate notification-only or self-declaration route for registrable devices, and no abridged route keyed to a foreign approval.

Conditions
  • The certificate is granted only to an establishment 'régulièrement déclaré' under art. 7.
  • Distributors and pharmacies may only acquire devices registered under the law (art. 7, final paragraph).

French original. Translation: 'The registration certificate is granted on application to any establishment for the manufacture or importation of medical devices duly declared to the administration in accordance with Article 7 above.'

Customs release gated on the registration certificate, a filing receipt, or visaed invoices

registration.customs-release-gate
Fact-level verified

Moroccan customs are instructed to make the import AND export of medical devices subject to presentation of a registration certificate or, as the case may be, a specific authorisation issued by the Direction du Médicament et de la Pharmacie, across all customs regimes including donations. Where the certificate cannot yet be presented, the importer is referred to that direction and customs release is conditional on one of: the registration certificate; a filing receipt for the registration dossier (attestation de dépôt du dossier d'enregistrement); or the duly visaed invoices. This is the operational form of the registration requirement: a pending application with a filing receipt is enough to clear a shipment.

Conditions
  • The circular dates from 3 March 2017 and refers to the Direction du Médicament et de la Pharmacie; the device competences described now sit with the AMMPS, but no superseding customs circular was located in this round.
  • An earlier circular n° 5979/311 of 25 October 2019 restates the same four accepted documents, so the position was unchanged as of that date.

French original. Translation: 'the service is instructed to make the import and export of medical devices, as defined above, subject to presentation of a registration certificate or a specific authorisation, as the case may be, issued by the said direction. This condition applies to all medical devices, all regimes combined, including donations. … failing presentation of the registration certificate … release shall be subject to the issue by that direction of one of the documents listed below: a registration certificate; a filing receipt for the registration dossier; or the duly visaed invoices.' The circular is served by the ADII document endpoint, which rejects plain curl requests with a WAF page and requires browser headers including a Referer.

Six categories of device are exempt from registration but need a specific authorisation

registration.specific-authorisation-route
Fact-level verified

Devices in six categories are outside the registration obligation and instead require a 'specific authorisation' delivered by the administration under conditions fixed by regulation: experimental devices imported or made locally for biomedical research; devices not marketed in Morocco that are prescribed to named patients; imported used devices intended for refurbishment and export; custom-made devices; samples imported for evaluation with a view to registration; and samples imported or made locally for display at trade fairs, scientific congresses and exhibitions.

Conditions
  • Devices shown at fairs must carry a visible notice that they may not be placed on the market or put into service before registration.
  • The conditions and procedure for the specific authorisation are fixed by arrêté n° 2855-15 of 4 August 2015.

French original. Translation: 'By way of derogation from the provisions of Article 12 above, the following are not subject to the registration obligation: … However, these medical devices must be the subject of a specific authorisation delivered by the administration under the conditions and procedure defined by regulation.'

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Morocco approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Morocco (6 records)

MoroccoJapan MHLW / PMDA · South Korea MFDS

Prior approval / evidence record

Japan PMDA / Korea MFDS / other non-listed approvals

Authority

Japan PMDA / Korea MFDS / other non-listed approvals

Accepted

No

Benefit

No Moroccan device instrument examined in this round names them, and the AMMPS reliance framework is scoped to medicines and vaccines, so they carry no listed documentary route for a device.

Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossierDécret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an updateDécision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete applicationLoi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossierArrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MoroccoEU conformity assessment · US FDA

Prior approval / evidence record

Full technical documentation waived for imported devices; only class III clinical data required

reliance.imported-device-technical-documentation-waiver
Fact-level verified
Statement

For imported medical devices the registration dossier's technical part is lighter than for locally manufactured devices: under arrêté n° 2855-15 art. 2, 1) b) the technical pieces for an imported device of any class are the manufacturer's declaration of conformity to the essential requirements (or equivalent requirements), the draft labelling and, where applicable, draft instructions for use, and a sale-model sample or prototype; the technical documentation with a conformity check-list, the corresponding standards and the internal documents relied on — a mandatory item for locally manufactured devices under art. 2, 2) b) — is not a filing item but may be requested from the establishment during the evaluation of the device's clinical data. The AMMPS checklist (footnote 5 to item 10) restates this as 'la documentation technique n'est pas obligatoire' for imported devices and adds that clinical data must be supplied for class III. This documentary lightening is keyed to the device's imported status, not to a named reference authority; for classes Is, Im, IIA, IIB and III the imported device must in any event file the origin-country competent-authority certificate (CE, FDA, CVL or equivalent), so in practice that certificate plus the declaration of conformity and, for classes IIA–III, an ISO 13485 certificate stand in for the technical file. The 120-day review clock and the national decision are unchanged.

Source Approval

EU CE marking certificate; US FDA attestation; or origin-country marketing authorisation / certificat de vente libre (CVL) equivalent — the certificate that made the device registrable in its origin country

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The lightening is attached to the technical-documentation item only; the administrative pieces, declaration of conformity, ISO 13485 certificate (classes IIA/IIB/III), origin-country certificate (classes Is/Im/IIA/IIB/III), labelling and IFU drafts and sample are still required.
  • For a class III imported device, clinical data must be filed (checklist footnote 5); the AMMPS may also call for the check-list documentation during clinical-data evaluation (arrêté art. 2, 1) b), last paragraph).
  • Locally manufactured (FL) devices must file the technical documentation with check-list (arrêté art. 2, 2) b)); semi-finished imports (ISF) file the imported-device administrative pieces plus the local-manufacture technical pieces and a GMP certificate (art. 2, 3)).
  • There is no recognition or abridged-review procedure behind this: the AMMPS recognition guidelines (LD RE-001, LD EA-013) cover medicines and vaccines only.

French original footnote (5) to dossier item 10. Translation: '(5) For imported DMs: the technical documentation is not mandatory, only the clinical data have to be supplied for class III DMs'. The waiver is an administrative-practice rule on the AMMPS's official dossier form, not a provision of loi 84-12 or décret 2-14-607; it is therefore bounded to the dossier item it annotates.

MoroccoEU conformity assessment · US FDA

Prior approval / evidence record

Origin-country CE / FDA / free-sale certificate is a mandatory dossier item for classes Is, Im, IIA, IIB and III

reliance.origin-country-approval-certificate
Fact-level verified
Statement

A medical-device registration application must include a certificate issued by the competent authority of the country of origin: an EU CE marking certificate, an 'FDA' attestation, a marketing-authorisation / free-sale certificate (CVL), or an equivalent. The item is mandatory for risk classes IIA, IIB and III and for sub-classes Is and Im of class I. It does not shorten the Moroccan review: the device is still registered nationally and the certificate sits alongside the national dossier.

Source Approval

EU CE marking certificate; US FDA attestation; or an origin-country marketing authorisation / certificat de vente libre (CVL) or equivalent issued by the competent authority of the country of origin

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to classes Is, Im, IIA, IIB and III; plain class I devices are outside the list.
  • The certificate must come from the competent authority of the country of origin, not from the manufacturer.
  • Footnote 1 of the same checklist adds that a CE design-examination certificate is required in addition to the CE quality-system certificate for class III devices.
  • The dossier is filed by the Moroccan establishment (declared manufacturing or importing establishment), not by the foreign manufacturer.

French original. Translation: '4- CE marking certificate or "FDA" attestation or marketing authorisation (CVL) or equivalent issued by the competent authorities in the country of origin (for DM belonging to risk classes IIA, IIB and III and sub-classes Is and Im of class I)'. Checklist Réf. DE ER DM/01, édition 9, date d'application 30/01/2025. The checklist is the AMMPS's own official dossier form; the same list is re-issued on each edition.

MoroccoEU conformity assessment

Prior approval / evidence record

EU CE marking certificate

Authority

EU CE marking certificate

Accepted

No

Benefit

Mandatory dossier item 4 for classes Is, Im, II A, II B and III, with a CE design-examination certificate additionally required for class III. It does not shorten the review: the device is still registered nationally by the AMMPS, and the AMMPS recognition framework covers medicines and vaccines only.

Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossierDécret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an updateDécision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete applicationLoi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossierArrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MoroccoSource authority not specified

Prior approval / evidence record

Origin-country free-sale certificate (certificat de vente libre, CVL)

Authority

Origin-country free-sale certificate (certificat de vente libre, CVL)

Accepted

No

Benefit

The third accepted form of dossier item 4 evidence, and the one a manufacturer outside the EU, US and comparable regimes would normally use. It must be issued by the competent authority of the country of origin, and it is evidence inside the national review rather than a substitute for it.

Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossierDécret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an updateDécision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete applicationLoi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossierArrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MoroccoUS FDA

Prior approval / evidence record

US FDA attestation

Authority

US FDA attestation

Accepted

No

Benefit

Accepted as an alternative to the CE certificate for dossier item 4. Dossier evidence only — no abridged or recognition route for devices exists.

Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossierDécret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an updateDécision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete applicationLoi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossierArrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

The administration has 90 days from filing of an establishment declaration to request information, visit the premises and notify observations; silence is tacit acceptance

clock.establishment-declaration-90-days-tacit-acceptance
Fact-level verified

Article 8 of loi 84-12 gives the administration a maximum of ninety days from the date the establishment declaration (article 7) is filed to ask the declarant for any additional information, carry out the visit of the establishment's premises and, where applicable, notify the observations it must take into account. Once that period has passed, the administration's silence is deemed tacit acceptance.

Conditions
  • Applies to the declaration of manufacturing, importing, exporting or distribution establishments; modifications must be re-declared within one month (décret 2-14-607 art. 2).

Effective from 2013-09-19

French original. Translation: 'The administration has a maximum period of ninety days from the date of filing of the declaration referred to in article 7 to request any additional information from the declarant, visit the premises of the establishment concerned and, where applicable, notify it of the observations it must take into account. After this period, the administration's silence is considered tacit acceptance.'

The administration may oppose advertising to health professionals within 30 days of receiving the prior declaration

clock.professional-advertising-declaration-30-day-opposition
Fact-level verified

Advertising of medical devices to health professionals entitled to prescribe or use them is subject to a prior declaration to the competent administration accompanied by the promotional material; the administration may, within thirty days from the date of receipt of the declaration, oppose the advertising if the proposed material does not comply with articles 31 and 32 (registered devices only; non-misleading, objective, consistent with the registration file).

Conditions
  • Advertising to the public instead needs a prior visa (art. 34) for which no delay is published.

Effective from 2013-09-19

French original. Translation: 'The administration may, within thirty days from the date of receipt of the declaration, oppose the advertising if the proposed promotional material does not comply with the requirements of articles 31 and 32 above.'

Registration decision within a maximum of 120 days from filing of the complete dossier

clock.registration-decision-120-days
Fact-level verified

The Minister of Health decides on a registration application within a maximum of one hundred and twenty days from the date the complete dossier is filed. Any refusal of registration must be reasoned and notified to the applicant.

Conditions
  • The clock runs from filing of the COMPLETE dossier; the time taken to complete the dossier is not counted. No clock is set for the specific authorisation route.

French original. Translation: 'The Minister of Health rules on the registration application within a maximum period of one hundred and twenty days from the date of filing of the complete dossier. Any refusal of registration must be reasoned and notified to the interested party.'

Specific authorisations are issued within 15 days (investigational devices), 3 days (named-patient devices), 15 days (used devices for refurbishment and export), 15 days (custom-made), 2 days (evaluation samples) and 7 days (exhibition samples) of a complete file

clock.specific-authorisation-delays-15-3-15-15-2-7-days
Fact-level verified

Article 15 of arrêté 2855-15 fixes a maximum delay from the filing of the complete file for each specific authorisation, 'sauf refus motivé': 15 days for investigational devices (valid for the duration of the clinical investigation and the number of devices needed); 3 days for a device not marketed in Morocco prescribed to a named patient (valid for one import); 15 days for used devices imported for refurbishment and export (one import-export operation); 15 days for custom-made devices (valid 24 months); 2 days for imported samples for evaluation with a view to registration (endorsed on the pro-forma invoice, one import); and 7 days for samples for exhibition at fairs, congresses and exhibitions (one import).

Conditions
  • Delays run from the complete dossier ('à compter de la date de dépôt du dossier complet').
  • The existing special-access fact records the urgent public-health authorisation of loi art. 21, which has no published delay.

Effective from 2016-02-01

French original; the six delay sentences are quoted in the order of article 15 points 1 to 6 (investigational, named-patient, used-for-refurbishment, custom-made, evaluation samples, exhibition samples). The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Exceptional authorisation for urgent public-health need pending registration

special-access.urgent-public-health-authorisation
Fact-level verified

Where public-health needs require it, and in an emergency, the government authority responsible for health may exceptionally authorise the placing on the market and putting into service of medical devices while the registration procedure is being completed, provided the manufacturer or importer justifies that the device has undergone verification of its efficacy, quality and safety under normal conditions of use.

Conditions
  • This is a temporary authorisation pending the art. 14 registration procedure, not a substitute for it.
  • A separate, narrower route exists for devices not marketed in Morocco that are prescribed to named patients, which requires a specific authorisation under loi 84-12 art. 13 (see registration.specific-authorisation-route).

French original. Translation: 'When public-health needs require it, and in case of emergency, the government authority responsible for health may exceptionally authorise the placing on the market and putting into service of medical devices, while awaiting completion of the registration procedure provided for in Article 14 above, provided that the manufacturer or importer justifies that the device in question has undergone verification of its efficacy, its quality and its safety under normal conditions of use.'

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

The good-practice rules for manufacture, transport, storage, distribution and performance evaluation of devices are those of Moroccan standard NM ISO 13485 in force

standards.good-practices-are-moroccan-standard-nm-iso-13485
Fact-level verified

Article 3 of arrêté 2856-15 provides that the rules of good practice for the manufacture, transport, storage, distribution and performance evaluation of medical devices (required by article 11 of loi 84-12) are those set out in the Moroccan standard NM ISO 13485 in force.

Conditions
  • NM ISO 13485 is the Moroccan adoption of ISO 13485; the arrêté refers to the version 'en vigueur' without date.

Effective from 2016-02-01

French original. Translation: 'Article 3. The rules of good practice for the manufacture, transport, storage, distribution and performance evaluation of medical devices are those contained in the Moroccan standard NM ISO 13485 in force.' The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Devices emitting ionising radiation must first satisfy the radiation-protection legislation, and the registration file must carry proof of it

standards.ionising-radiation-protection-compliance-before-registration
Fact-level verified

Article 19 of loi 84-12 requires devices emitting ionising radiation to have satisfied, before their registration, the conditions laid down by the legislation and regulations on protection against ionising radiation. Article 4 of arrêté 2855-15 makes their registration subject to presentation of a document evidencing satisfaction of those conditions.

Conditions
  • The radiation-protection authority and its licence are outside loi 84-12 (loi 142-12 on nuclear and radiological safety, AMSSNuR); this fact records only the device-law prerequisite.

Effective from 2013-09-19

French original. Translation: 'Medical devices emitting ionising radiation must, before their registration, have satisfied the conditions provided by the legislation and regulations on protection against ionising radiation.' Arrêté 2855-15 art. 4 (OCR): « L'enregistrement des dispositifs médicaux émettant des rayonnements ionisants a lieu conformément aux règles prévues par le présent arrêté, sous réserve de la présentation d'un justificatif de satisfaction aux conditions prévues par la législation et la réglementation relatives à la protection contre les rayonnements ionisants. »

The registration dossier's technical documentation is a checklist of conformity to the essential requirements naming the corresponding standards and internal documents; mandatory for local manufacture, on request for imports

standards.technical-documentation-checklist-cites-essential-requirements-and-corresponding-standards
Fact-level verified

For a locally manufactured device the registration dossier must contain technical documentation comprising a checklist demonstrating the device's conformity to the essential requirements of quality, safety and performance, indicating those not applicable, together with the corresponding standards and the reference to the internal documents used. For an imported device the same documentation may be called for during the evaluation of the clinical data.

Conditions
  • Class-dependent conformity evidence (CE certificate/FDA/CVL for classes IIA, IIB, III, Is, Im; ISO 13485 certificate for IIA, IIB, III) is already recorded under reliance and QMS.

Effective from 2016-02-01

French original. The Bulletin officiel pages are a scan without text layer; the passage was read by OCR (pdftoppm 200 dpi + Tesseract fra) and checked visually for the quoted words; obvious OCR artefacts corrected in the excerpt.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Refusal must be reasoned and notified; AMMPS operates a recours channel

submission.reasoned-refusal-and-review-channel
Fact-level verified

Any refusal of a device registration must be reasoned and notified to the applicant. The AMMPS publishes a 'Déposer un recours' channel on its site alongside its 'Déposer une réclamation' channel, giving applicants an administrative review route. Applications and all correspondence run through the AMMPS; the establishment's legal representative signs and stamps the file.

Conditions
  • The 120-day decision clock and the reasoned-refusal duty come from décret 2-14-607 art. 4; the recours channel is an AMMPS service, not a statutory appeal with a fixed clock.

French original. Translation: 'Any refusal of registration must be reasoned and notified to the interested party.' The recours and réclamation channels are published on the AMMPS site navigation.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Traceability rules apply to designated devices according to degree of danger; list fixed by regulation

traceability.rules-by-device-class
Fact-level verified

Persons responsible for establishments manufacturing, importing, exporting and distributing medical devices, health establishments and health professionals must apply traceability rules to certain medical devices according to their degree of danger, within the limits of their respective responsibilities. The list of those devices and the rules governing their traceability are fixed by regulation. No unique-device-identification (UDI) system is established by loi 84-12.

Conditions
  • The list and traceability rules are to be fixed by voie réglementaire; no such arrêté was located in this round.

French original. Translation: 'The persons responsible for establishments manufacturing, importing, exporting and distributing medical devices, health establishments as well as health professionals are required to apply, within the limits of their respective responsibilities, the traceability rules for certain medical devices according to their degree of danger. The list of these medical devices as well as the rules for their traceability are fixed by regulation.'

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

National materiovigilance system; incidents reportable to the administration within 48 hours

vigilance.materiovigilance-48-hour-reporting
Fact-level verified

Materiovigilance covers the surveillance of incidents or risks of incidents arising from the use of medical devices after they are placed on the market, through a national materiovigilance system whose organisation and operation are fixed by regulation. The persons responsible for manufacturing, importing, exporting and distributing establishments, and health professionals who use medical devices, must report to the administration within forty-eight hours any incident or risk of incident arising from the use of a device, and any failure or deterioration in the quality of those products of which they become aware.

Conditions
  • The AMMPS operates the materiovigilance function under loi 10-22 and receives notifications through its 'Notifier un effet indésirable' channel.
  • The reporting duty is not limited to serious incidents: 'tout incident ou risque d'incident' and any quality failure or deterioration.

French original. Translation: 'The persons responsible for establishments manufacturing, importing, exporting and distributing medical devices, as well as health professionals using medical devices, are required to report to the administration within forty-eight (48) hours any incident or risk of incident resulting from the use of a medical device, as well as any failure or deterioration in the quality of the said products of which they have become aware.'

Related structured datasets

Classification systems · 1 record
Open Classes I, II A, II B and III (loi 84-12 art. 4) →
Id

morocco:medical-device

Jurisdiction Id

morocco

Domains
  • medical-device
Name

Classes I, II A, II B and III (loi 84-12 art. 4)

Description

Morocco classifies medical devices nationally by degree of danger into four classes: I (risque potentiel faible), II A (risque potentiel modéré), II B (risque potentiel élevé) and III (risque critique). The axis is set by loi n° 84-12 art. 4 and the detailed classification rules are delegated to arrêté n° 2856-15, whose full text could not be retrieved. The class is determined by the AMMPS in the registration review; no reliance route shortens that review, but where the device conforms to a foreign regime the competent authority's certificate is a mandatory dossier item.

Classes
  • Id

    i

    Label

    Classe I — risque potentiel faible

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Classe II A — risque potentiel modéré

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Classe II B — risque potentiel élevé

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Classe III — risque critique

    Normalized Risk Level

    highest

Regulator

Agence Marocaine des Médicaments et des Produits de Santé (AMMPS)

Official Domains
  • ammps.gov.ma
  • sante.gov.ma
Source Status

official-source-verified

Reference Sources
  • Title

    Décret n° 2-14-607 du 18 septembre 2014, article 9 — the classification rules of loi 84-12 art. 4 are fixed by arrêté of the Minister of Health (arrêté n° 2856-15 of 4 August 2015)

    Url

    https://www.sante.gov.ma/Reglementation/REGLEMENTATIONAPPLICABLEAUPRODUITSDESANTE/2-14-607.pdf

    Reviewed On

    2026-09-16

    Supports

    The decree applies loi 84-12 art. 14 and art. 4 and delegates the classification rules, essential requirements and good-manufacturing rules to ministerial arrêtés; it is the instrument that carries the national registration dossier and its review.

  • Title

    AMMPS medical-device registration checklist (Réf. DE ER DM, dossier items 1 to 17), item 4

    Url

    https://www.ammps.gov.ma/uploads/documents-dynamiques/checklist-d-enregistrement-des-dispositifs-medicaux-1-1782206095.pdf

    Reviewed On

    2026-09-16

    Supports

    The checklist ties the dossier to the risk class: the competent-authority certificate of the country of origin (CE marking certificate, FDA attestation, or free-sale certificate) is required for classes Is, Im, II A, II B and III, and a CE design-examination certificate is additionally required for class III.

Source Title

Loi n° 84-12 relative aux dispositifs médicaux, article 4

Source Url

https://www.ammps.gov.ma/uploads/textes-reglementaires/lois/loi-84-12-relative-aux-dispositifs-medicaux.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
Registration pathways, prior approvals and planning · 1 record
Open Morocco registration →
Country

Morocco

Jurisdiction Id

morocco

Country Code

MA

Flag

🇲🇦

Regulator

Agence Marocaine des Médicaments et des Produits de Santé

Regulator Abbrev

AMMPS

Region

africa

Tier

3

Risk Classification

4-class (I, II A, II B, III) — loi 84-12 art. 4

Classes
  • Id

    ammps-initial-registration

    Class Name

    Initial device registration — all risk classes

    Pathway

    National dossier review: the application is addressed to the Minister of Health and the certificat d'enregistrement is delivered by the administration after consultation of the commission nationale consultative des dispositifs médicaux (loi 84-12 arts. 12 and 14; décret n° 2-14-607 art. 4)

    Official Timeline
    Min

    120

    Max

    120

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossier

    Url

    https://www.sante.gov.ma/Reglementation/REGLEMENTATIONAPPLICABLEAUPRODUITSDESANTE/2-14-607.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • The clock is décret n° 2-14-607 art. 4, third paragraph: the Minister of Health decides within a maximum of one hundred and twenty days from the date the COMPLETE dossier is filed. The instrument sets no period for completing a dossier, so time spent answering deficiencies and producing missing items falls outside the 120 days.
    • This is a national dossier review, not a reliance route: the AMMPS recognition framework published in 2026 states that it covers medicines and vaccines only, so a CE, FDA, PMDA or MFDS approval does not shorten this clock — it is dossier item 4 evidence alongside the national file.
    • One clock is set for every risk class, so no riskLevel is recorded on this row.
    • The dossier is filed by the declared Moroccan establishment, not by the foreign manufacturer.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    ammps-post-registration-update

    Class Name

    Post-registration update (mise à jour) of the certificate

    Pathway

    Update application under arrêté n° 2855-15, distinct from a fresh registration application where the change bears on the nature of the device (loi 84-12 art. 16)

    Official Timeline
    Min

    20

    Max

    20

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an update

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/arretes/arrete-2855-15-relatif-aux-dispositifs-medicaux.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    4

    Notes
    • Arrêté n° 2855-15 art. 11: the administration decides on an update application within a maximum of 20 days from filing of the complete dossier, and any refusal must be justified and communicated to the establishment.
    • This 20-day clock is the modification clock only; the 120-day clock applies to a first registration application.
    • Changes bearing on the nature of the device require a new registration application instead of an update.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    anrt-equipment-agrement

    Class Name

    ANRT agrément — radio and telecommunications terminal equipment

    Pathway

    Prior agrément by equipment, delivered by the ANRT on application to its services (Décision ANRT/DG/N°16/24 arts. 2, 3 and 11)

    Official Timeline
    Min

    15

    Max

    15

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Décision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete application

    Url

    https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    4

    Notes
    • Article 11 of the décision expresses the period as fifteen (15) jours ouvrables; the 15-day figure is the instrument's own number and the working-day basis is recorded here because the registry's unit vocabulary is days, weeks and months only.
    • The clock runs from receipt of the complete application and is suspended where the ANRT issues a deficiency notice, which gives the applicant ten days to respond; it resumes from the requested supplement.
    • Article 7 gives the agrément a validity of ten years, and art. 15 requires the specific absorption rate to be displayed from 1 May 2025.
    • Applies only where the device contains radio transmitting or receiving equipment or terminal equipment attachable to a public network; a stand-alone device is not caught.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    amssnur-ionizing-radiation-authorisation

    Class Name

    AMSSNuR authorisation — ionizing-radiation installations, activities and sources

    Risk Level

    high

    Pathway

    Authorisation from the Agence for the installation or activity and the ionizing-radiation sources associated with it (loi n° 142-12 arts. 7 and 45)

    Official Timeline
    Min

    2

    Max

    6

    Unit

    months

    Verification Status

    official-verified

    Official Source
    Title

    Loi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossier

    Url

    https://www.mem.gov.ma/Lists/Lst_Textes_Reglementaires/Attachments/8/loi-142-12.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • Loi n° 142-12 art. 46: the authorisations are delivered by the Agence within a period of two (2) to six (6) months running from the date of receipt of the complete dossier, and the period is fixed by regulation for each of the classes set by art. 4 of the law.
    • Article 45 makes the authorisation conditional on, among other things, the conformity of the radiation sources to the design and manufacturing standards required for their certification, the radioprotection qualifications of the personnel, and the safety analysis of the installation.
    • The authorisation attaches to the installation, the activity and their operator, so it is separate from the AMMPS device registration and is held at the site of installation and use.
    • The implementing decree is décret n° 2-20-131 du 25 février 2021; its class-by-class rules were not retrieved and are not asserted on this row.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    ammps-advertising-visa

    Class Name

    Advertising of medical devices to the public — visa de publicité

    Pathway

    Application for the visa de publicité addressed to the Minister of Health, on a dossier whose content and grant procedure are fixed by ministerial arrêté; the Minister decides after the opinion (avis) of the Commission nationale consultative des dispositifs médicaux (décret n° 2-14-607 art. 14, implementing art. 34 of loi n° 84-12)

    Official Timeline
    Min

    60

    Max

    60

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Décret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/decrets/decret-2-14-607-application-loi-84-12-dispositifs-medicaux-18-septembre-2014.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • NOT A REGISTRATION CLOCK — this row is deliberately separate from the registration rows. Décret n° 2-14-607 art. 14, troisième alinéa: 'Le ministre de la santé décide de l'octroi du visa de publicité après avis de la commission nationale consultative des dispositifs médicaux, et ce dans un délai maximum de soixante jours à compter de la date du dépôt du dossier complet.' It governs advertising to the public, not market access, and it must not be folded into the 120-day registration clock.
    • METHOD NOTE for reviewers: article 14 is invisible in the Bulletin officiel print hosted on sante.gov.ma, whose two-column layout makes text extraction truncate the article mid-way; it was recovered from the AMMPS-hosted clean text version of the same decree, where articles 4 and 14 both read cleanly. The two copies agree word for word on art. 4.
    • The clock runs from filing of the complete dossier, like the registration clock, and the same limitation applies: the decree fixes no period for the administration to raise a completeness objection, so the start is in practice controlled by the administration.
    • Two periods in the decree are internal to the administration rather than decision clocks and are not published here: art. 17 second alinéa gives the commission a second deliberation within fifteen days of a first meeting that lacked a quorum, which bounds the delay an avis can cause; art. 23 quatrième alinéa gives the inspection service seven days to transmit its report to the Minister.
    • Only a device holding a certificat d'enregistrement may be advertised, so this row sits behind the registration rows rather than beside them.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    EU CE marking certificate

    Accepted

    No

    Benefit

    Mandatory dossier item 4 for classes Is, Im, II A, II B and III, with a CE design-examination certificate additionally required for class III. It does not shorten the review: the device is still registered nationally by the AMMPS, and the AMMPS recognition framework covers medicines and vaccines only.

  • Authority

    US FDA attestation

    Accepted

    No

    Benefit

    Accepted as an alternative to the CE certificate for dossier item 4. Dossier evidence only — no abridged or recognition route for devices exists.

  • Authority

    Origin-country free-sale certificate (certificat de vente libre, CVL)

    Accepted

    No

    Benefit

    The third accepted form of dossier item 4 evidence, and the one a manufacturer outside the EU, US and comparable regimes would normally use. It must be issued by the competent authority of the country of origin, and it is evidence inside the national review rather than a substitute for it.

  • Authority

    Japan PMDA / Korea MFDS / other non-listed approvals

    Accepted

    No

    Benefit

    No Moroccan device instrument examined in this round names them, and the AMMPS reliance framework is scoped to medicines and vaccines, so they carry no listed documentary route for a device.

Key Requirements
  • The applicant must be a Moroccan manufacturing or importing establishment declared to the administration under loi n° 84-12 art. 7; the registration certificate is granted only to such an establishment.
  • The registration dossier is a fixed seventeen-item paper file (application letter and fiche signalétique in triplicate, manufacturer's attestation, the competent authority's certificate of the country of origin, declaration of conformity, GMP certificate, labelling and instructions-for-use drafts, technical documentation, colour catalogue and a sample), all dated, signed and stamped by the legal representative of the Moroccan establishment.
  • A copy of the quittance for the registration fees, obtained from the régie, must be filed with the dossier.
  • The competent-authority certificate of the country of origin (CE marking certificate, FDA attestation, free-sale certificate or equivalent) is mandatory for classes Is, Im, II A, II B and III, and a CE design-examination certificate is additionally required for class III.
  • For imported devices the technical documentation item is waived and only clinical data are required, and only for class III; the rest of the dossier still applies.
  • Customs release of imported devices is conditioned on presentation of a registration certificate or, as the case may be, a specific authorisation under loi 84-12 art. 13.
  • Only devices holding a registration certificate may be advertised, and advertising requires a prior visa from the Minister of Health.
  • The registration holder must report any incident or risk of incident to the administration — the materiovigilance duty covers every incident and any quality failure, not only serious ones.
Local Rep Required

Yes

Local Rep Name

Établissement marocain déclaré (fabricant ou importateur) — the registration certificate is granted only to an establishment declared to the administration under loi n° 84-12 art. 7

Mdsap Accepted

No

Mdsap Benefit

No MDSAP route: the AMMPS assesses the national dossier (loi 84-12 art. 14; arrêté n° 2855-15), and the quality-system evidence it requires is a good-manufacturing-practice certificate issued by the Moroccan administration, not an MDSAP audit report.

Registration Validity

5 years, renewable, in the conditions fixed by arrêté of the Minister of Health (décret n° 2-14-607 art. 6)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossier

    Url

    https://www.sante.gov.ma/Reglementation/REGLEMENTATIONAPPLICABLEAUPRODUITSDESANTE/2-14-607.pdf

    Accessed Date

    2026-09-16

  • Title

    Décret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14)

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/decrets/decret-2-14-607-application-loi-84-12-dispositifs-medicaux-18-septembre-2014.pdf

    Accessed Date

    2026-09-16

  • Title

    Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an update

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/arretes/arrete-2855-15-relatif-aux-dispositifs-medicaux.pdf

    Accessed Date

    2026-09-16

  • Title

    Décision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete application

    Url

    https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf

    Accessed Date

    2026-09-16

  • Title

    Loi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossier

    Url

    https://www.mem.gov.ma/Lists/Lst_Textes_Reglementaires/Attachments/8/loi-142-12.pdf

    Accessed Date

    2026-09-16

  • Title

    Arrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/arretes/arrete-2855-15-relatif-aux-dispositifs-medicaux.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by AMMPS. Appoint a Établissement marocain déclaré (fabricant ou importateur) — the registration certificate is granted only to an establishment declared to the administration under loi n° 84-12 art. 7.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to AMMPS including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    AMMPS reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. AMMPS may issue questions.

    Duration

    120 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, AMMPS issues Morocco market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Morocco fees →
Jurisdiction Id

morocco

Country

Morocco

Country Code

MA

Authority

Agence Marocaine des Médicaments et des Produits de Santé (AMMPS)

Low Risk Local
Min

1000

Max

1000

Currency

MAD

Per Product

Yes

High Risk Local
Min

1000

Max

1000

Currency

MAD

Per Product

Yes

Details
  • Id

    device-registration-certificate

    Item

    Certificat d'enregistrement d'un dispositif médical

    Currency

    MAD

    Amount Local

    1000

    Amount Local Formatted

    1 000 MAD (TTC)

    Frequency

    Per registration certificate

    Notes

    Listed under 'Autorisations et certificats réglementaires' in the AMMPS tariff schedule, whose preamble states the amounts are expressed in Moroccan dirhams TTC. The registration checklist requires a copy of the quittance for the registration fees (obtained from the régie) to be filed with the dossier, so this is the amount actually payable on a first registration.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ammps.gov.ma/pages/tarification

    Source Title

    AMMPS tariff schedule — 2. Autorisations et certificats réglementaires (amounts in dirhams marocains TTC)

    Verified On

    2026-09-16

  • Id

    ivd-reagent-registration-certificate

    Item

    Certificat d'enregistrement d'un réactif à usage diagnostic in vitro

    Currency

    MAD

    Amount Local

    500

    Amount Local Formatted

    500 MAD (TTC)

    Frequency

    Per registration certificate

    Notes

    The same tariff line group carries a separate, lower amount for an in-vitro diagnostic reagent, which confirms that IVD reagents are inside the AMMPS registration perimeter even though they are governed by loi n° 11-08 rather than loi 84-12. The 1 500 DH figure that appears in the older arrêté conjoint n° 783-06 is superseded and is not the current schedule.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ammps.gov.ma/pages/tarification

    Source Title

    AMMPS tariff schedule — 2. Autorisations et certificats réglementaires (amounts in dirhams marocains TTC)

    Verified On

    2026-09-16

  • Id

    anrt-agrement-study-fee

    Item

    Frais d'études d'agrément d'un équipement (ANRT)

    Currency

    MAD

    Amount Local

    500

    Amount Local Formatted

    500 MAD (HT)

    Frequency

    Per equipment item

    Notes

    Décision ANRT/DG/N°16/24 art. 6(c) fixes the study fee at 500 dirhams hors taxes per equipment. It is a condition of an ANRT agrément and is therefore payable only where the device contains radio or telecommunications terminal equipment; it is additional to, and independent of, the AMMPS registration fee.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf

    Source Title

    Décision ANRT/DG/N°16/24, article 6(c) — agrément study fee of 500 dirhams hors taxes per equipment

    Verified On

    2026-09-16

Notes
  • The AMMPS tariff schedule is flat by certificate type and does not vary the amount by the device's risk class, so the low-risk and high-risk bands carry the same figure and no risk-differentiated range exists.
  • The schedule publishes no renewal, variation or establishment-declaration line item; the amounts above cover a first registration certificate, an IVD reagent registration certificate and the ANRT agrément study fee only.
  • The ANRT amount is expressed hors taxes while the AMMPS amounts are TTC, which is how each instrument publishes them.
  • The origin-country approval certificate required as dossier item 4 does not carry a separate AMMPS fee.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    AMMPS tariff schedule — 2. Autorisations et certificats réglementaires (amounts in dirhams marocains TTC)

    Url

    https://www.ammps.gov.ma/pages/tarification

    Accessed Date

    2026-09-16

  • Title

    Décision ANRT/DG/N°16/24, article 6(c) — agrément study fee of 500 dirhams hors taxes per equipment

    Url

    https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

No

Additional certifications and licences · 1 record
Open Morocco certifications →
Slug

morocco

Market

Morocco

Confidence

low

Schemes
  • Id

    morocco-anrt-radio-equipment-agrement

    Name

    ANRT radio-equipment agrément

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Décision ANRT/DG/N°16/24 du 28 joumada II 1446 (30 décembre 2024), published in Bulletin Officiel n° 7376 du 6 février 2025, requires prior agrément from the ANRT before radio equipment is manufactured, imported, marketed or held in Morocco: art. 2 states the duty and art. 3 lists the equipment caught. Art. 6(c) fixes the study fee at 500 dirhams hors taxes per item, art. 7 gives the agrément a ten-year validity, and art. 11 requires the ANRT to notify its decision within fifteen (15) working days of receipt of a complete application, with a ten-day deficiency notice that suspends the clock. Art. 15 adds a duty to display the specific absorption rate from 1 May 2025. A medical device is caught only where it contains radio transmitting or receiving equipment.

    Source Urls
    • https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf
    Source Binding

    reviewed

  • Id

    morocco-anrt-terminal-equipment-agrement

    Name

    ANRT telecommunications terminal equipment agrément

    Category

    Telecom Network Attachment

    Status

    Mandatory If Feature

    Object

    Terminal Equipment

    Note

    The same Décision ANRT/DG/N°16/24 covers telecommunications terminal equipment alongside radio equipment: art. 3 lists the equipment subject to agrément, including terminal equipment intended to be connected to a public telecommunications network, and art. 2 makes the prior agrément duty apply to manufacture, import, marketing and possession for sale. The study fee (art. 6(c)), the ten-year validity (art. 7) and the fifteen-working-day notification period from a complete application (art. 11) are the same. A device with a network-connection function (for example a device that transmits readings over a public network) is caught; a stand-alone device with no network interface is not.

    Source Urls
    • https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf
    Source Binding

    reviewed

  • Id

    morocco-amssnur-ionizing-radiation-authorisation

    Name

    AMSSNuR authorisation for ionizing-radiation installations and sources

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Source Or Installation

    Note

    Loi n° 142-12 relative à la sûreté et à la sécurité nucléaires et radiologiques (dahir n° 1-14-149 du 22 août 2014, Bulletin Officiel n° 6292 du 18 septembre 2014) art. 45 makes the authorisations of art. 7 conditional, among other things, on the conformity of the ionizing-radiation sources 'aux normes de conception et de fabrication requises pour leur certification' and on the safety analysis of the installation, and art. 77 requires those sources to conform to Moroccan standards or, failing that, to the required international standards. Art. 46 gives the Agence a decision period of two to six months from receipt of the complete dossier. The authorisation attaches to the installation and its operator, so a device that generates ionizing radiation is caught through the site where it is installed and used, not through the device registration. The implementing decree on authorisations and declarations for these activities is décret n° 2-20-131 du 25 février 2021, recorded as such in CNESTEN's regulatory framework; the decree text itself was not retrieved and its class-by-class rules are therefore not asserted here.

    Source Urls
    • https://www.mem.gov.ma/Lists/Lst_Textes_Reglementaires/Attachments/8/loi-142-12.pdf
    Source Binding

    reviewed

Official Sources
  • Authority

    Agence Marocaine des Médicaments et des Produits de Santé (AMMPS)

    Topic

    loi n° 84-12 relative aux dispositifs médicaux — class axis and registration duty

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/lois/loi-84-12-relative-aux-dispositifs-medicaux.pdf

  • Authority

    Ministère de la Santé et de la Protection Sociale

    Topic

    décret n° 2-14-607 du 18 septembre 2014 — implementing decree of loi 84-12, registration procedure and 120-day decision

    Url

    https://www.sante.gov.ma/Reglementation/REGLEMENTATIONAPPLICABLEAUPRODUITSDESANTE/2-14-607.pdf

  • Authority

    AMMPS

    Topic

    arrêté n° 2855-15 du 4 août 2015 — device registration, update and renewal dossier and the 20-day update decision

    Url

    https://www.ammps.gov.ma/uploads/textes-reglementaires/arretes/arrete-2855-15-relatif-aux-dispositifs-medicaux.pdf

  • Authority

    AMMPS

    Topic

    AMMPS tariff schedule — autorisations et certificats réglementaires

    Url

    https://www.ammps.gov.ma/pages/tarification

  • Authority

    AMMPS

    Topic

    medical-device registration checklist — dossier items and risk classes

    Url

    https://www.ammps.gov.ma/uploads/documents-dynamiques/checklist-d-enregistrement-des-dispositifs-medicaux-1-1782206095.pdf

  • Authority

    Agence Nationale de Réglementation des Télécommunications (ANRT)

    Topic

    Décision ANRT/DG/N°16/24 — equipment agrément: duty, scope, fee, validity and notification period

    Url

    https://www.anrt.ma/sites/default/files/2025-04/Decision-Agrement-16-24-Ver-exploitable-FR.pdf

  • Authority

    Ministère de l'Industrie et du Commerce

    Topic

    liste des normes marocaines (NMO) et de la réglementation technique, version du 19-06-2026 — arrêtés n° 2573-14 and n° 2574-14

    Url

    https://www.mcinet.gov.ma/sites/default/files/Liste%20NMO%20et%20reglementation%20technique%20V%2019-06-2026.pdf

  • Authority

    Agence Marocaine de Sûreté et de Sécurité Nucléaires et Radiologiques (AMSSNuR)

    Topic

    loi n° 142-12 — authorisation of ionizing-radiation installations, activities and sources (Bulletin Officiel n° 6292 du 18 septembre 2014)

    Url

    https://www.mem.gov.ma/Lists/Lst_Textes_Reglementaires/Attachments/8/loi-142-12.pdf

  • Authority

    CNESTEN (Centre National de l'Énergie, des Sciences et des Techniques Nucléaires)

    Topic

    cadre réglementaire — listing décret n° 2-20-131 du 25 février 2021 on authorisations and declarations for ionizing-radiation activities, installations and sources

    Url

    https://www.cnesten.org.ma/etalonnage

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DJ Fang
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Confirm the current AMMPS pathway, evidence, and local-role details for the actual device before filing.
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