Eight Statutory Conditions for Obtaining Marketing Approval: Article 6 (a)-(h) Broken Down Item by Item

1. Key takeaways

Article 6(1)(a)–(h) of Federal Decree-Law No. 38/2024 is the substantive threshold for a medical device marketing authorization in the UAE, comprising 8 conditions: applicant eligibility (a); quality assurance, traceability, vigilance and post-market follow-up systems (b); the compliance of reference-country marketing approvals and evaluation results such as clinical assessment (c); a certificate of analysis or a batch quality certificate (d); intellectual property and trademark compliance (e); a GMP certificate (f); complete information on the inner and outer packaging and the instructions for use, consistent with the EDE labelling guidance (g); and other conditions prescribed by the executive regulations (h). Our judgement is that (a) and (f) determine whether the application can be filed at all, (c) and (g) determine how many rounds of corrections it will take, and (h) determines how many unknowns remain. Article 6(2) contains separate provisions for generic products.

• Article 6(1)(a)–(h) sets out eight conditions: applicant eligibility, quality and traceability and vigilance systems, reference-country evaluation, certificates of analysis, intellectual property, GMP, labelling, and reserved conditions.
• Conditions (a) and (f) gate the filing; conditions (c) and (g) drive the number of correction rounds; condition (h) holds the unknowns.
• Article 6(2) contains separate provisions for generic products.

2. Legal basis

The table below gathers the eight-condition provision, the generic-product and GMP provisions, and the current EDE service terms whose document lists and timelines translate those conditions into operational requirements.

3. Expert insights

Insight 1: Condition (a) gates applicant eligibility at the level of the establishment, not of the product. Condition (a) restricts applicants to marketing offices, medical product manufacturers, contract manufacturing companies or a medical warehouse designated by the rights holder. Our judgement is that Chinese manufacturers usually do not qualify as direct applicants and must first resolve the local-entity question: the marketing office or medical warehouse must hold a valid licence, and the MAH and the manufacturing site must first be registered with the EDE. This means that entity preparation is a pre-task of the filing, and its completeness directly determines whether the 45-working-day review clock can even start.

Insight 2: Condition (c) establishes reliance review, but the hierarchy of evidence must be organised proactively. Condition (c) requires an evaluation of the compliance of the reference-country marketing approval, taking into account clinical evaluation, bioequivalence and post-market outcomes. The EDE practises reliance review, referencing approvals by the EMA, the United States FDA, the United Kingdom MHRA, Australia’s TGA, Switzerland’s Swissmedic, Health Canada and Japan’s MHLW/PMDA, and intends to update the list of reference authorities. Our judgement is that companies holding only a Chinese NMPA registration certificate cannot assume acceptance; they should first clarify their position in the evidence hierarchy through classification and written confirmation, and then decide on the reinforcement path (see Article 14 for details).

Insight 3: Condition (h) is the largest single uncertainty in this round of compliance, and it is handled by written confirmation rather than by inferring from practice. Condition (h) leaves other conditions to the executive regulations, and the executive regulations to the 181-article decree have not yet been issued in full. Our judgement is that every matter reserved under condition (h) should be confirmed in writing by the EDE and archived; industry practice produces no compliance effect. At the same time, the GMP certificate under condition (f) may be issued by the EDE, by the competent authority of the country of origin, or by a reference authority recognised by the EDE, and the choice among these routes should be fixed before filing to avoid mid-review rework over certificate recognition.

4. Practical recommendations

• Build an eight-column evidence table following (a)–(h), marking for each column the evidence document name, issuing body, validity period and gap, with a separate rectification plan for gap items.
• Entity qualifications first: submit the product application only after the marketing office or medical warehouse licence and the EDE registration of the MAH and manufacturing site are complete.
• Organise condition (c) evidence around reference-authority approvals as the main line, incorporating post-market outcomes and vigilance data rather than submitting only scanned certificates.
• Fix the GMP certificate route under condition (f) before filing, checking that the certificate scope covers the products to be registered and avoiding a scope mismatch.
• Prepare the Arabic version of the labelling and instructions for use under condition (g) in accordance with the EDE labelling guidance, keeping it consistent with the intended use stated in the technical documentation.
• Make written enquiries to the EDE on each matter reserved under condition (h), archive the replies and use them as the filing basis, without substituting industry practice.

5. Verification checklist

• □ The eight-column (a)–(h) evidence table has been completed, with a clear rectification owner and deadline for each gap item.
• □ It has been confirmed that the applicant is one of the four categories of entities under condition (a), and that the relevant licences are valid.
• □ It has been confirmed that the MAH and the manufacturing site have completed EDE registration.
• □ It has been confirmed that the reference-country approval documents under condition (c) are complete, accompanied by post-market outcomes and vigilance data.
• □ It has been confirmed that the GMP certificate issuer meets condition (f) and that the certificate scope covers the products to be registered.
• □ It has been confirmed that the labelling and instructions for use satisfy condition (g) and the EDE labelling guidance, including the Arabic version.
• □ Written EDE replies on the matters reserved under condition (h) have been obtained and archived.
• □ The internal preparation plan has been reverse-scheduled from the official timeline of 45 working days (practical estimate: from zero preparation to formal market entry, 6–18 months).

Further reading: Article 06 “The Mandatory Nature of Marketing Approval: The Red Line of Article 5 and the Two Exemptions”; Article 08 “Five-Year Validity and Renewal: Article 7 and the EDE’s Official Renewal Service Terms”; Article 18 “Manufacturing Site Registration: The Order of the GMP Certificate and Site Registration”.

Regulatory information verified as of October 29, 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 registrations and free-zone (DHCC) pathways, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com