Local authorised representative and power of attorney: the UAE legalisation chain

1. Key takeaways

A foreign manufacturer cannot file an application with EDE in its own name; it must rely on a licensed UAE entity. This practical constraint flows directly from the design of applicant eligibility in Article 6(1)(a). A local authorised representative (LAR) is not a window that merely helps hand over documents; it is a link in the chain of rights-holder obligations under Article 21. We recommend binding this relationship with three instruments: a power of attorney (POA) whose scope of authorisation is written out item by item, a notarisation and embassy legalisation chain that is complete and traceable, and a contract that expressly reserves ownership of the marketing authorisation certificate in the hands of the manufacturer.

• Applicant eligibility under Article 6(1)(a) forces foreign manufacturers to act through a licensed UAE entity.
• The LAR sits inside the rights-holder obligation chain of Article 21, whose paragraph 6 requires compliance with EDE vigilance guidance.
• The POA must state the product list, the authorisation period and the matters that may be handled, and must exclude sub-delegation.
• Ownership of the marketing authorisation certificate should be contractually reserved to the manufacturer from the outset.

2. Legal basis

The table below consolidates the provisions that govern the LAR relationship and the documents EDE expects to see, combining the applicant-eligibility rule, the rights-holder duties, the multi-entity designation requirement and the product agency contract listed on the EDE service page.

3. Expert insights

Insight 1: the scope of the POA must be written out item by item; a general all-purpose authorisation is a common hidden risk. The EDE service page lists the product agency contract as a required document, which shows that the regulator wants to see a specific product range, a specific term and a specific scope of affairs. The direct consequence of a sweeping authorisation is that the agent asserts powers under the POA beyond what the manufacturer expected, and the manufacturer discovers mid-project that the grant is hard to claw back. The workable approach is to give the POA a defined product list, a defined authorisation period and a defined list of matters it may handle, and to state expressly that sub-delegation is not permitted.

Insight 2: every link in the legalisation chain must be internally consistent with the document itself. The complete chain is usually notarisation abroad, authentication by the foreign ministry or an authorised body, and legalisation by the UAE embassy in that country. What is authenticated is the seal of the issuing body and the authority of the signatory, not the technical content, so any modification made after notarisation breaks the chain. The foreign entity name, address and signatory title on the POA must match the application documents and the free sale certificate of the country of origin exactly; a single inconsistency is enough to trigger a request for supplementary documents.

Insight 3: Article 22 changes the functional positioning of the LAR. Under the multi-entity architecture, the several designated establishments each perform their own role, with one lead establishment uniformly handling licensing affairs, vigilance and whole-lifecycle management. This means the authorisation relationship is no longer a single linear delegation from one rights holder to one representative, but a set of parallel authorisation arrangements that must not conflict with one another. We recommend building hierarchy into the POA text: distinguish a master authorisation, product-level authorisations and matter-level authorisations, so that the authorised scopes of multiple establishments do not collide at the import stage.

4. Practical recommendations

• Verify the original licence of the LAR, confirm that the licence type, scope of activities and registered address match the submission documents, and retain a verification record.
• In the POA, list the product list, the authorisation period, the matters that may be handled and a clause prohibiting sub-delegation; never use sweeping general language.
• After embassy legalisation is complete, lock the document version; any later change goes back through notarisation afresh and is never edited onto the already legalised text.
• In the contract, separately stipulate that ownership of the marketing authorisation certificate rests with the manufacturer, and set out certificate handover, stock buy-back and data handover arrangements upon termination.
• Reserve authorisation hierarchy for the Article 22 multi-entity architecture, and define the information exchange and reporting paths between the lead establishment and the other establishments.

5. Verification checklist

• □ A valid licence verification record for the LAR has been obtained, and the licence type and scope of activities match the role in the submission
• □ The POA lists the product list, the authorisation period and the scope of affairs, and contains a clause prohibiting sub-delegation
• □ The three-tier chain of notarisation, foreign-ministry authentication and embassy legalisation is complete, and the signatory authority is verifiable
• □ The foreign entity details on the POA match the free sale certificate and the application form word for word
• □ The contract sets out certificate ownership, handover upon termination, and stock and vigilance data handover clauses
• □ An expiry alert for the POA has been established, so that no authorisation vacuum arises after lapse
• □ The authorised scopes of all grantees have been cross-checked, with no overlap or conflict

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