Transfer of Registration Certificates under Article 17 of Law 84-12

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

Article 17 of Law No. 84-12 provides that any change of holder of a registration certificate is conditional on obtaining a transfer authorisation (autorisation de transfert) issued by the competent authority, with the modalities and procedure set by regulation. Article 8 of ministerial order Arrêté n° 2855-15 adds that the application must be submitted by the transferee establishment, together with the transfer agreement of the original holder. Changing a Moroccan partner is therefore not an update of contact details; it is a registered transfer requiring administrative approval, and its mechanics must be planned before they are needed.

The transfer regime is also the reason why certificate control dominates channel economics in Morocco. Because the certificate travels with the holding establishment and moves only through this administrative procedure, the incumbent partner holds an asset the manufacturer cannot redeploy unilaterally. Deals to switch partners should therefore be priced with the transfer timeline in mind: review periods, the transferee’s qualification work, and the drafting of the transfer agreement all consume calendar time before any new shipment can lawfully carry the incoming partner’s name as importer of record.

2. Legal basis

InstrumentReference numberPublication dateProvisions
Medical Devices Law (Loi n° 84-12)Dahir n° 1-13-9030 August 2013Article 17; Article 12; Article 43 (penalties for unauthorised transfer)
Ministerial order on registration and placing on the market of medical devicesArrêté n° 2855-154 August 2015Article 8 (submission by the transferee with the transfer agreement attached)
Implementing decree of Law No. 84-12 (Décret n° 2-14-607)Décret n° 2-14-60718 September 2014Article 6 (validity period; the transfer does not reset the 5-year cycle)

3. Expert insights

Insight 1: Article 17 uses the wording “subordonné à” — conditional upon — which makes the authorisation a mandatory precondition. Effectively changing the holder without a transfer authorisation falls squarely within Article 43, which punishes the transfer of a device registration without having first obtained the administrative authorisation under Article 17: for Class I and Class IIA devices, a fine of MAD 200,000 to MAD 500,000; for Class IIB and Class III devices, 2% to 5% of turnover (floor MAD 500,000). The penalty applies to the act of transferring, regardless of whether the commercial deal was otherwise legitimate, so the sequencing — authorisation first, then change of control of the certificate — is not optional.

Insight 2: The applicant is the transferee establishment, not the original holder. Article 8 of Arrêté n° 2855-15 fixes the submitting party as the transferee and requires the original holder’s transfer agreement to be attached. The practical implication is that the new partner leads the application while the old partner cooperates by issuing the agreement. If the old partner refuses to cooperate, the transfer stalls — which is exactly the scenario that cooperation agreements must anticipate in advance. GRZAN recommends treating the outgoing holder’s cooperation duty as a negotiated, priced contractual term rather than an assumed courtesy.

Insight 3: The transferee must already qualify to hold the certificate. Article 12, second paragraph, requires the holder to be a manufacturing or import establishment duly declared under Article 7. A transfer therefore presupposes that the new partner has completed its establishment declaration. If the new partner has not yet declared, the whole process must be prefixed with the Article 7 declaration and the 90-day window of Article 8. Planning the transfer timeline means auditing the transferee’s declaration status first, not after the transfer agreement has been signed.

Insight 4: The transfer does not change the 5-year validity. Article 6 of Décret n° 2-14-607 provides that the registration certificate is valid for 5 years and renewable. A transfer changes the holder, not the validity clock: the renewal date remains calculated from the original issuance date. When pricing a transfer, parties should remember that the incoming holder inherits both the remaining validity and the approaching renewal workload, which affects the allocation of renewal costs in the transfer negotiation.

Insight 5: Imports and sales during the transfer period carry a gap risk. While the transfer application is pending, the certificate remains in the original holder’s name. If goods are imported in the new partner’s name during that window, a mismatch arises between the certificate-holder and the importer. Scheduling must cover this transition window: either imports are completed under the outgoing holder before the application, or they wait until the authorisation is issued. A mismatched shipment risks customs complications precisely at the moment when commercial relations are most delicate.

4. Practical recommendations

  1. Stipulate the transfer cooperation duty in the cooperation agreement. Provide expressly that, upon termination of cooperation, the original holder must issue the transfer agreement within an agreed period and support the transfer application.
  2. Confirm the new partner’s qualification before starting the transfer. Verify that the transferee has completed its declaration under Article 7 and that its declared activity type matches.
  3. Organise the file around submission by the transferee. The new partner leads the application; the original partner issues the transfer agreement; record the division of work in a handover plan.
  4. Schedule around the transition window. Plan imports and sales during the pending transfer period in advance to avoid a mismatch between certificate-holder and importer.
  5. Refresh the downstream authorisation chain. After the transfer, re-issue authorisation letters to distribution establishments under Article 1, item 11.

5. Verification checklist

  • □ Confirmed that the transfer authorisation under Article 17 is a mandatory precondition
  • □ The new partner has completed its establishment declaration under Article 7 with a matching activity type
  • □ The transfer agreement has been issued by the original holder
  • □ The transfer application has been submitted by the transferee establishment
  • □ Import and sales arrangements during the transfer review period have been planned
  • □ The renewal date has been calculated from the original issuance date (the 5-year cycle does not reset)
  • □ Distribution authorisation letters have been re-issued after completion of the transfer

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with certificate transfer planning, negotiation of transfer cooperation clauses, transferee qualification checks, and cost budgeting for registration and maintenance obligations. For support on the requirements described above, contact info@grzanglobal.com.

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.

What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.

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