MAH eligibility in the UAE: marketing office versus medical warehouse as licence holder

1. Key takeaways

Marketing authorisation holder (MAH) status is the gate that stands in front of every UAE submission; it is not simply a field on an application form. Article 6(1)(a) of Federal Decree-Law No. 38/2024 restricts eligible applicants to four categories of entities: a marketing office, a manufacturer of medical products, a contract manufacturing company, or a medical warehouse designated by the rights holder. For a manufacturer based outside the UAE, the genuinely workable options usually reduce to two: have a licensed marketing office hold the certificate, or appoint a licensed medical warehouse to hold it. Our selection criterion is who will carry the downstream obligations, not whose licence is easier to obtain. The licence holder simultaneously assumes the quality assurance, product traceability, vigilance and post-market follow-up obligations under Article 6(1)(b), and must also be able to absorb the import and distribution architecture that Article 22 requires. Deciding the holder entity first, and only then designing the import chain, is the sequence that avoids structural rework.

• Article 6(1)(a) limits applicants to four entity types; for foreign manufacturers the practical choice is usually a marketing office or a medical warehouse.
• The licence holder carries quality assurance, traceability, vigilance and post-market follow-up duties under Article 6(1)(b).
• A marketing office licence focuses on promotion and registration matters and does not inherently include receiving, storage and distribution capability.
• Designation of a medical warehouse by the rights holder must be documentarily demonstrable, typically carried by a power of attorney together with a warehousing agreement.

2. Legal basis

The entity-eligibility rules below are drawn from Federal Decree-Law No. 38/2024 and from the conditions published on the current EDE service page for the issuance of medical device marketing authorisations. Each row states the provision relied on and its operative point.

3. Expert insights

Insight 1: a marketing office is a licence-holding entity whose licensed activities exclude warehousing and distribution. The licensed activities of a marketing office concentrate on market promotion and registration affairs; they do not naturally include the ability to receive, store and dispatch goods. Treating the question of whether a warehouse can receive shipments as an implicit condition of choosing the holder entity confuses the boundary between the two distinct licensed activities of a marketing office and a medical warehouse. For manufacturers with many product models and frequent changes, holding the certificate through a marketing office helps centralise the management of variations and renewals under Article 15, but a licensed warehousing partner must be contractually locked in writing before the submission is filed; otherwise the certificate may arrive while import documentation still cannot be issued.

Insight 2: where a medical warehouse holds the certificate, the source of eligibility is the legal relationship of designation by the rights holder. The wording of Article 6(1)(a) refers to a medical warehouse designated by the rights holder, so the designation relationship between the rights holder and the warehouse must be provable, and it is typically carried by a power of attorney combined with a warehousing agreement. We recommend batching the notarisation and legalisation of this designation document together with the free sale certificate of the country of origin. Supplying it separately afterwards often prompts EDE, during the document-repair stage, to trace the legal relationship between the entities backwards, creating a round of correspondence that could have been avoided. Note also that a medical warehouse and a medical store are different licensed activities, and the latter cannot substitute for the former as the licence-holding entity.

Insight 3: EDE moves entity-eligibility screening ahead of product assessment. The EDE service page states expressly that the MAH and the manufacturing site must first be registered with EDE, and that the marketing office or medical warehouse must hold a valid licence. This means the official review period of 45 working days does not cover the time needed for entity registration and site registration. Starting these two preliminary registrations only after the product dossier is finalised pushes uncontrollable time cost into a stage that cannot be compressed. We recommend launching them at the latest in parallel with the dossier self-check.

4. Practical recommendations

• Decide the licence-holding entity type first, then design the importer and distributor architecture under Article 22, so that entity eligibility and import arrangements never conflict.
• Verify the original licence of any proposed local licensed entity, confirm the licence type and scope of activities, and retain a verification record.
• Batch the notarisation and legalisation of the rights-holder designation document, the power of attorney and the free sale certificate of the country of origin to compress the number of round trips.
• In the contract, settle clearly the ownership of the marketing authorisation certificate, the cooperation duties upon expiry, and the rules for certificate handover and stock disposition when the cooperation ends.
• Start MAH registration and manufacturing site registration in parallel; both are preliminary conditions stated on the EDE service page and must not be queued serially behind the product dossier.

5. Verification checklist

• □ The licence type of the proposed holder entity has been confirmed in writing as a marketing office or a medical warehouse, and the licence is within its validity period
• □ The scope of licensed activities of that entity has been checked, with no situation in which a medical store substitutes for a medical warehouse
• □ The rights-holder designation document and the power of attorney have completed notarisation and legalisation, and the foreign entity details match the application form word for word
• □ MAH registration and manufacturing site registration have been submitted and receipts of acceptance from EDE obtained
• □ Written documentation of the quality assurance, traceability, vigilance and post-market follow-up systems is complete
• □ The contract sets out certificate ownership, cooperation duties, handover upon termination and stock disposition clauses
• □ It has been confirmed that the holder entity can absorb the import and distribution interfaces required by the Article 22 architecture

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team coordinates local authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com