Who Can Hold the Registration Certificate in Morocco

1. Key takeaways

Article 12, second paragraph, of Law No. 84-12 restricts the recipients of the registration certificate to manufacturing or import establishments that have been duly declared under Article 7. A foreign manufacturer is not an eligible applicant and cannot hold the certificate directly. This single provision determines the first step a Chinese manufacturer must take when entering Morocco: before preparing any product dossier, the manufacturer must identify the certificate-holding establishment, because the identity of that establishment determines which entity signs every subsequent document in the market-access chain.

The logic of the Moroccan system differs fundamentally from the European model. In the European Union, a foreign manufacturer appoints an authorised representative to hold a compliance role on its behalf. In Morocco, the legislator chose an establishment-declaration model: a local company first declares itself as a manufacturing or import establishment under Article 7, and then obtains the registration certificate in its own name. The certificate-holder is therefore the rights holder, not a mere agent of the manufacturer. Every commercial decision — distributor appointments, channel exclusivity, certificate transfers — flows from this structural fact.

2. Legal basis

3. Expert insights

Insight 1: Morocco has no authorised representative role. Under the European system, a foreign manufacturer relies on an authorised representative (EC REP) to hold its compliance identity. The Moroccan design is an establishment-declaration system — a local company first declares itself as a manufacturing or import establishment under Article 7 and then obtains the registration certificate in its own name. The two roles differ in legal status: a European authorised representative is the manufacturer’s mandated agent, whereas the Moroccan certificate-holding establishment is the rights holder of the registration certificate. This difference shapes every contractual arrangement a foreign manufacturer can make in Morocco, because the legal title to market access sits with the local entity, not with the manufacturer itself.

Insight 2: The holder is the rights holder, which makes negotiating positions asymmetric. The registration certificate is registered in the name of the certificate-holding establishment, and Article 17 requires that any change of holder be approved through a transfer authorisation issued by the competent authority. For a Chinese manufacturer, replacing its Moroccan partner is therefore not a matter of switching suppliers; it requires initiating an administrative procedure whose success depends on cooperation from the outgoing holder. This is the single most important structural risk to address during channel negotiation, well before any dispute arises, because the party that controls the certificate also controls the continuity of market access.

Insight 3: One product sold through several importers usually requires several certificates. The recipient of the certificate under Article 12, second paragraph, is the establishment, not the product. When two Moroccan importers each import the same product, each importer typically needs its own certificate for that product. This multiplies dossier preparation, official fees, and ongoing maintenance work across the channel. It also means that exclusivity arrangements in Morocco acquire real legal force only through control of the certificate: whoever holds the registration for a given territory effectively controls who may lawfully place that product on the market there.

Insight 4: Local manufacturing can bypass this restriction. Article 7 covers manufacturing establishments. If a Chinese manufacturer establishes a manufacturing or assembly site in Morocco, that site may declare itself under Article 7 and, under Article 12, second paragraph, hold the registration certificate directly. Against the backdrop of localisation strategies for the Moroccan market, this route deserves evaluation whenever the market justifies a durable presence. It converts the manufacturer from a dependent of a local holder into the holder itself, eliminating transfer risk entirely.

Insight 5: The certificate-holder carries independent obligations. Article 16 requires the holder to keep clinical data under continuous evaluation and to notify changes in writing. Article 25 requires the holder to report vigilance incidents within 48 hours. Article 29 requires the holder to carry out recalls and disposals. These obligations fall on the certificate-holding establishment, not on the foreign manufacturer. The manufacturer must nevertheless ensure, through contract, that the holder actually has the operational capacity to perform them, because a failure by the holder can interrupt the product’s lawful presence in the market and expose the whole channel to enforcement.

4. Practical recommendations

1. Treat holder selection as a strategic decision. Assess each candidate’s declaration status, business scope, warehousing capability, vigilance capability, and the efficiency of its signature and authorisation processes — not only its price.
2. Lock the transfer mechanism into the agreement. Define the circumstances in which the holder must cooperate in initiating a transfer authorisation under Article 17, and specify liability for refusal to cooperate.
3. Quantify certificate numbers and costs by channel. A multi-importer model means multiple dossiers, multiple fee streams, and multiple maintenance lines; budget for all of them at the outset.
4. Write the holder’s statutory obligations into the agreement. Map each obligation under Articles 16, 25, and 29 to a specific contract clause and a named responsible person.
5. Preserve the option of local manufacturing. If the Moroccan market is strategically important over the long term, evaluate the feasibility of establishing a manufacturing establishment that can declare under Article 7 and hold certificates directly.

5. Verification checklist

• □ Confirmed that a foreign manufacturer cannot hold the Moroccan registration certificate directly
• □ The candidate certificate-holding establishment has completed its declaration under Article 7
• □ The candidate establishment’s declared business activities include import (or manufacturing)
• □ The agreement sets out the cooperation mechanism for a transfer authorisation under Article 17
• □ The holder’s obligations under Articles 16, 25, and 29 are written into the contract clauses
• □ Certificate numbers and maintenance costs have been estimated by channel
• □ The medium- and long-term feasibility of holding certificates through a local manufacturing site has been evaluated

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with the selection and audit of local certificate-holding establishments and importers, drafting of cooperation and transfer agreements, and full cost budgeting for registration, renewal, and maintenance obligations. For tailored support on the license-holder requirements described above, contact info@grzanglobal.com.