ANRT Type Approval for Wireless Medical Devices in Morocco

1. Key takeaways

Medical devices with wireless functions such as Wi-Fi and Bluetooth must pass two tracks in Morocco. The first track is the AMMPS registration certificate under Article 12 of Law No. 84-12. The second track is type approval (agrément) from the national telecommunications regulator (ANRT), obtained as a radio equipment product. The two tracks run in parallel and do not replace each other, and the ANRT approval number must be marked on the label. GRZAN’s recommendation is to start the approval schedule and the registration schedule at the same time, because the approval number must be printed on the final label, and a lag forces label rework.

The status of the device as a medical device does not create an exemption from telecommunications approval. GRZAN found no basis in the verification for an exemption of medical devices from radio approval in Morocco. An intraoral camera with Wi-Fi is both a medical device and a radio device, and both sets of requirements must be met in full.

Validity periods also run on different clocks. The practical estimate for the ANRT approval is a validity of approximately 10 years, while the AMMPS registration certificate is valid for 5 years under Article 6 of Décret n° 2-14-607. The two cycles must be tracked separately, with separate reminders, or one will silently lapse while attention is on the other.

2. Legal basis

Practical estimate: the ANRT application route (through the PortNet single window, with acceptance of European or United States test reports), the validity period of approximately 10 years, and the label marking requirement come from industry practice sources and are a practical estimate. GRZAN found no exemption basis for medical devices from radio approval in this verification.

3. Expert insights

Insight one: medical device status does not produce a telecommunications exemption. GRZAN found no exemption for medical devices from radio type approval in Morocco during this verification. A Wi-Fi-equipped intraoral camera is both a medical device and a radio device, and both sets of requirements apply. This differs from the treatment of medical electrical equipment, which is excluded from the CMIM low voltage and electromagnetic compatibility directives; the latter is an exclusion, whereas the ANRT track is an addition on top of registration. Planning that assumes an exemption because of medical status is planning on a basis the framework does not provide.

Insight two: the time relationship between the two tracks determines when the label is finalized. The ANRT approval number must be printed on the label, and the draft label is itself part of the AMMPS registration dossier. The reasonable sequencing is either to submit the draft label with the registration dossier together with a statement that approval is in progress and finalize the label once approval is obtained, or to obtain the approval before submission and finalize the label in one pass. The first option requires confirming that the competent authority accepts a draft plus a statement; the second option trades schedule risk for certainty on the label.

Insight three: test reports can be reused. The practical estimate is that ANRT accepts European or United States Federal Communications Commission (FCC) test reports. Chinese manufacturers who already hold relevant radio frequency test reports can assess their acceptability and reduce duplicate testing. The assessment should be done before scheduling any new testing, since an unnecessary duplicate test campaign is one of the easiest costs to remove from a wireless project.

Insight four: the difference in validity periods requires separate management. The practical estimate gives the ANRT approval a validity of approximately 10 years, while the AMMPS registration certificate is valid for 5 years (Article 6 of Décret n° 2-14-607). The two cycles are out of step, so the register must carry separate reminders for each track, and renewal planning for one must not be allowed to mask the expiry of the other.

Insight five: a model change triggers both tracks at once. A change of the wireless module affects the ANRT approval, which is granted for a specific model, and may also trigger the change notification or re-application requirements of Article 16 for the registration. Change management must evaluate both tracks together, because a module swap that looks purely electrical can invalidate an approval number printed on labels already in the field.

4. Practical recommendations

1. Identify wireless functions at project initiation. Mark in the product list whether each model contains Wi-Fi, Bluetooth, or cellular modules, so the second track is visible before schedules are built.
2. Start both schedules in parallel. Advance the ANRT approval and the AMMPS registration simultaneously, so the finalization of the label is not held hostage to whichever track runs slower.
3. Assess the acceptability of existing radio test reports. Where European or FCC test reports exist, evaluate their acceptability first and cut duplicate testing costs before commissioning new tests.
4. Reserve the approval number field in the label layout. Position the field at the design stage and fill it in once approval is granted, avoiding a reprint of the entire label run.
5. Set reminders on both cycles separately. Manage expiry and change reminders for the ANRT approval (approximately 10 years, practical estimate) and the AMMPS certificate (5 years) as two independent entries in the register.

5. Verification checklist

• □ Wireless function modules marked model by model
• □ Absence of an exemption for medical devices from radio approval confirmed
• □ ANRT type approval started in parallel with AMMPS registration
• □ Acceptability of existing European or FCC test reports assessed
• □ ANRT approval number field reserved in the label layout
• □ Approval number marked on the final label as required
• □ Register carries separate reminders for the two validity periods
• □ Dual-track change evaluation process established for wireless module changes

GRZAN supports manufacturers of wireless and connected medical devices entering the Moroccan market, including dual-track scheduling of AMMPS registration and ANRT type approval, reuse assessments for existing radio test reports, label field planning, and dual-cycle validity management. For assistance with registration documentation and conformity files for Morocco, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026