Regulatory Reliance: How EDE Recognises Reference Authority Approvals

1. Key takeaways

The United Arab Emirates applies a reliance-based review to medical devices, and its statutory anchor is Article 6(1)(c) of Federal Decree-Law No. 38/2024: the applicant must assess the compliance of the reference-country marketing authorization and must also assess the clinical evaluation, bioequivalence and post-market outcomes. Our judgment is that a reference-country approval is a piece of evidence that can be accepted, not an automatic pass. EDE takes account of approvals issued by the EMA, the US FDA, the UK MHRA, Australia’s TGA, Swissmedic, Health Canada and Japan’s MHLW/PMDA, and is updating the list of reference authorities. That list is dynamic: not being on the current list does not bar a filing, but the burden of proof rises noticeably.

• Article 6(1)(c) requires the applicant to evaluate the compliance of the reference-country marketing authorization together with the clinical evaluation, bioequivalence and post-market outcomes.
• EDE references approvals from the EMA, US FDA, UK MHRA, Australian TGA, Swissmedic, Health Canada and Japan’s MHLW/PMDA, and the reference authority list is being updated.
• A reference-country approval is evidence to be assessed, not a substitute for the other conditions in Article 6; applicant eligibility, GMP certification and labelling each stand on their own.
• Reliance under Article 6(1)(c) and the entity arrangements under Article 22 do not replace each other; both must be in place for an approval to become an operable business.

2. Legal basis

The reliance framework rests on Article 6 of Federal Decree-Law No. 38/2024 and on the EDE service page for the issuance of a medical device marketing authorization, summarised below.

3. Expert insights

Insight 1: Article (c) uses the word assess, not recognise. The provision requires the applicant to assess the compliance of the reference-country marketing authorization, which tells us that EDE retains the power of substantive judgment. On that basis we never promise a client that a reference-country approval alone secures the certificate. We position the reference approval as the starting point of an evidence chain: the approval certificate, a summary of the review conclusions, the approved scope and any restrictions, and the post-market outcomes must be submitted as a coherent package so that EDE has material it can evaluate. Uploading a lone certificate accomplishes nothing more than handing the judgment over entirely.

Insight 2: While the list is being updated, written confirmation beats industry practice. The list of reference authorities is in the middle of an update process, and Article 6(1)(h) reserves further conditions for the Executive Regulations. Our operating rule is that any question of whether a certificate from a given country will be accepted, or whether a given type of evidence is sufficient, is locked down through official EDE channels in writing before the filing strategy is fixed. Success stories circulating among peers do not constitute a basis for filing, and they carry no reusability.

Insight 3: Reliance review and Article 22 do not substitute for each other. Reference-country evidence answers whether the product is acceptable; Article 22 answers who bears responsibility inside the UAE. Even with a complete evidence chain, the rights holder must appoint at least 2 importers, at least 1 distributor, and 1 lead responsible entity to handle authorisation matters, vigilance and whole-lifecycle management in a unified way, and every appointed entity must actually carry out imports in the year concerned. Evidence preparation and entity structuring should be scheduled in parallel; obtaining the certificate first and patching the structure afterwards leaves an approval that cannot be operationalised.

4. Practical recommendations

• Organise the evidence around the reference-country approval as the main line: the approval certificate, the approved scope, the review conclusions and the post-market safety outcomes submitted as one set.
• Before submission, verify the status of the reference-country certificate, confirming that the validity period, the certificate holder and the approved scope cover the models to be filed.
• Disclose any conditions attached to the reference-country approval, such as post-market studies or time-limited supplementary data, in full and attach an execution plan.
• Where approval evidence falls outside the coverage of the reference list, obtain written confirmation from EDE first, before spending on translation and notarisation.
• Schedule the Article 22 entity structure in parallel with the filing, and have the vigilance contact of the lead responsible entity identified and in place before submission.
• Keep version records of the reliance evidence so it can be reused at renewal when the 5-year validity expires and at re-approval for major changes under Article 15.

5. Verification checklist

• □ The reference authorities to be relied on are listed, with the approval document numbers, approval dates and validity periods.
• □ The scope of the reference-country approval covers the models, intended purpose and target population to be filed.
• □ Submittable versions of the clinical evaluation, bioequivalence or post-market outcome material have been assembled.
• □ Any conditions attached to the reference-country approval are disclosed in the filing with an execution plan attached.
• □ Written confirmation or an official acceptance response from EDE has been obtained for evidence not covered by the list.
• □ The importer, distributor and lead responsible entity arrangements required by Article 22 have been started in parallel with the filing.

Regulatory information verified as of 29 October 2026.

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 manages MOHAP registration applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com