Ionising Radiation Devices: Radiation Protection before Registration

1. Key takeaways

Article 19 of Law No. 84-12 provides that medical devices emitting ionising radiation must, before their registration, first satisfy the conditions laid down by the laws and regulations governing protection against ionising radiation. This is a precondition clause: radiation protection approval is a prior step to registration, not a parallel procedure. Read together with the scope of Decision No. 630-26, imaging and radiotherapy equipment are the categories most concentratedly affected by this requirement.

For scheduling purposes, the consequence is simple: the radiation protection approval must be completed before the registration dossier is submitted, because the review clock only starts on a complete dossier. Leaving radiation documents to be supplied during the review converts a sequencing error into lost calendar time.

The category of devices concerned is also broader than a first reading suggests. Ionising radiation devices are not limited to diagnostic imaging: the same logic covers interventional systems operated under fluoroscopy, radiotherapy bunkers and their beam-producing equipment, and brachytherapy sources. For each of these, the radiation dimension touches not only the device itself but also the premises where it will be installed, which means the approval is partly a property-and-premises question tied to the Moroccan site. This reinforces the sequencing point: premises-level radiation approvals cannot be started overnight, and the licensed site must be involved long before the dossier is finalised, because without its radiation documentation the registration file will simply never be complete.

2. Legal basis

Verification note: the laws and regulations on protection against ionising radiation referred to in Article 19 point to the dedicated Moroccan radiation protection legislation. GRZAN did not obtain a unique reference number for that dedicated legislation in the course of this verification, and it is therefore referred to here as the radiation protection legislation in force in Morocco, without inventing a specific reference.

3. Expert insights

Insight 1: The French phrase préalablement à leur enregistrement is an express time marker. Translated literally, it means before their registration, and the legislator used it to place the radiation protection conditions at the front end of the registration procedure. Companies should treat radiation protection approval as a task to be completed before the registration dossier is submitted, not as a document to be supplied during the review.

Insight 2: This affects the starting point of the 120-day review period in Article 4 of Decree No. 2-14-607. The review period runs from the submission of a complete dossier. If radiation protection documents are missing, the dossier is incomplete and the 120-day clock does not start. Completing the prior approval first is, in substance, a way of protecting the company own review clock. It also protects the committee schedule: since the advisory committee of Article 36 is involved in registration applications, any correction cycle that pushes the dossier back also risks pushing the application past a committee meeting, which is time no applicant can recover.

Insight 3: The overlap with the scope of Decision No. 630-26 is extensive. Public information verified by GRZAN shows that the equipment list covered by the decision includes X-ray machines, interventional imaging systems, CT, MRI, gamma cameras, whole-body imaging systems, SPECT, SPECT/CT, PET, PET/CT and PET/MRI, as well as external beam radiotherapy equipment using ionising radiation, brachytherapy equipment and radiosurgery systems. Virtually the entire list consists of devices emitting ionising radiation, which means that products on the second-hand and refurbished pathway must satisfy both Article 19 and Decision No. 630-26 simultaneously.

Insight 4: Article 19 is a condition clause, not an exemption clause. Satisfying the radiation protection requirements does not replace registration and does not reduce the dossier requirements of Article 14; it merely precedes them in time. Both must be completed.

Insight 5: Installation and maintenance can equally be constrained. The on-site installation, commissioning and maintenance of imaging and radiotherapy equipment involve radiation premises management. Service agreements concluded with licensed sites should allocate radiation compliance responsibilities clearly between the parties. The allocation should be written, not implied: which party holds the premises approval, which party maintains the source or tube logs, which party reports incidents, and which party bears the cost of re-inspection. Verbal arrangements fail exactly when they are needed most, that is, when an inspector arrives.

4. Practical recommendations

1. Schedule radiation protection approval as a front-loaded task. Complete it before dossier submission and retain the approval documents as part of dossier completeness.
2. Add this item to the dossier completeness self-check. In the completeness checklist derived from Article 4 of Decree No. 2-14-607, list radiation protection documents as a separate line item, with the name of the issuing authority and the document reference recorded so that completeness can be verified objectively rather than remembered.
3. Run a double check for second-hand imaging equipment. Verify both the Article 19 precondition and the lifetime thresholds and new-product registration requirement of Decision No. 630-26 (see article 19).
4. Allocate radiation compliance responsibility in service agreements. State clearly which party bears compliance obligations for installation, commissioning and maintenance.
5. Track updates of the radiation protection legislation. That legislation may be revised independently of device regulations and needs its own tracking entry. Assign an owner inside the company for this tracking, since legislation outside the device field is the easiest to lose sight of during annual regulatory reviews.

5. Verification checklist

• □ It has been confirmed whether the product emits ionising radiation
• □ Approval documents under the radiation protection legislation in force in Morocco have been obtained
• □ The approval documents have been included in the registration dossier as a completeness requirement
• □ Radiation protection documents are listed as a separate item in the dossier completeness self-check
• □ Second-hand equipment has been checked simultaneously against Decision No. 630-26
• □ Installation and maintenance service agreements allocate radiation compliance responsibility
• □ Updates of the radiation protection legislation are included in the regulatory tracking list

GRZAN support for the Moroccan market. GRZAN assists manufacturers of imaging and radiotherapy equipment in sequencing radiation protection approval ahead of registration, verifying the scope of Decision No. 630-26, and structuring compliant installation and maintenance agreements for Morocco. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026