Manufacturer Site Registration: Sequencing GMP Certificates and Site Registration

1. Key takeaways

On sequencing, the United Arab Emirates gives a clear answer: site first, product second. Article 6(1)(f) requires a valid GMP certificate issued by EDE, by the competent authority of the country of origin, or by a reference authority recognised by EDE, and the EDE marketing authorization service page also states that the marketing authorization holder (MAH) and the manufacturing site must first be registered with EDE. Our judgment is that treating site registration as a parallel task to the product filing is one of the main reasons reviews are returned, because the filing system cannot establish the link to a site that has not been registered.

• Article 6(1)(f) requires a valid GMP certificate from one of three sources: EDE, the competent authority of the country of origin, or a reference authority recognised by EDE.
• The EDE service page makes registration of the MAH and the manufacturing site a precondition of the product filing, and the required documents include a valid factory registration certificate.
• Only after the site side is complete can the 45-working-day review on the product side truly start running.
• For contract manufacturing and multi-site production, every site must be registered and evidenced separately, and site changes feed through to the product certificate under Article 15.

2. Legal basis

The sequencing requirement rests on Article 6 of Federal Decree-Law No. 38/2024, on Article 126, and on the preconditions stated on the EDE service page, summarised below.

3. Expert insights

Insight 1: Item (f) names three issuing bodies, and Chinese manufacturers should choose the most stable one. The provision allows the GMP certificate to come from EDE, from the competent authority of the country of origin, or from a reference authority recognised by EDE, which is the channel the legislature preserved for overseas manufacturers. Our judgment is that companies already holding an ISO 13485 certificate whose scope covers the products to be registered should at the same time verify that the certificate scope matches the models to be filed, because a scope mismatch is a high-frequency reason for rejection. Where the certificate is in a renewal or scope-change period, wait for the change to complete before submitting, to avoid the certificate lapsing midway through the review.

Insight 2: A hard dependency exists between site registration and the product filing. The EDE service page lists the registration of the MAH and the manufacturing site as a precondition, and a valid factory registration certificate appears among the required documents. This means the 45-working-day review on the product side can only genuinely begin counting once the site side is complete. We therefore write the schedule as three segments, site registration, product filing, and review, with the duration and cost of the site registration stage budgeted at 14–28 working days and around AED 10,100 (practical estimate).

Insight 3: Contract manufacturing and multi-site situations must be unpicked early. Article 6(1)(a) lists contract manufacturing companies among the eligible applicants, which shows the legislature recognises commissioned production arrangements. Where the same product is manufactured across several sites, each site must complete registration and submit its own GMP evidence. Our position is to lock the site list before the filing and freeze it against change, because any change to a site transmits through to the product certificate and triggers the re-approval requirement for major changes under Article 15.

4. Practical recommendations

• Start the MAH and manufacturing site registration first, and submit the product filing only once proof of completed registration is in hand.
• Prepare the GMP certificate under one of the three sources in item (f), confirming the issuing body, the validity period and the coverage.
• Compare the ISO 13485 certificate scope against the products to be registered item by item, and complete a scope extension first where coverage is missing.
• For multi-site or contract manufacturing arrangements, prepare registration and GMP evidence separately for each site and list the site inventory in the filing.
• Freeze the site list before the filing, and assess any change of production address, process or key supplier under Article 15 for possible re-approval.
• Build the budget and schedule on the three segments: site registration (practical estimate), product filing of 45 working days, and the import and clearance stage.

5. Verification checklist

• □ Both the MAH and the manufacturing site are registered with EDE and hold valid proof of registration.
• □ The issuing body of the GMP certificate is one of the three sources listed in Article 6(1)(f).
• □ The scope of the GMP certificate and the ISO 13485 certificate covers the products to be registered and their production activities.
• □ Multi-site and contract manufacturing arrangements are stated in the filing, with evidence complete for each site.
• □ The site list was frozen before the filing, and a change assessment mechanism is in place.
• □ The schedule is built on the three segments of site registration, product filing and import clearance, without counting the total cycle backwards from the 45 working days.

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