🇲🇦 Morocco IVD regulatory data
Explore the IVD requirements currently available for Morocco, organized by topic and linked to official sources.
No source-linked IVD facts are currently published for this product scope. This does not establish that requirements or pathways are unavailable.
Changes after registration in Morocco
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
Does changing a device brand name or logo require an update?
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
How do I update a manufacturer's name without changing the legal entity?
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
What changes when the manufacturer's office address changes?
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Does a catalogue or reference code change affect registration or UDI?
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
Can a registration transfer to a different legal entity?
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Can several changes be filed together?
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
Related structured datasets
Classification systems · 0 records
No maintained record.
Registration pathways, prior approvals and planning · 1 record
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
- 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
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
- 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
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
- 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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