Entering the UAE with Only an NMPA Registration Certificate: Pathways and Reinforcement

1. Key takeaways

For companies holding only a Chinese NMPA registration certificate, the first step is not preparing documents but confirming how far that certificate can be relied on under the reliance review framework. The anchor of Article 6(1)(c) is the assessment of the compliance of a reference-country marketing authorization, and the list of authorities EDE references covers the EMA, the US FDA, the UK MHRA, Australia’s TGA, Swissmedic, Health Canada and Japan’s MHLW/PMDA, with the list still being updated. Our judgment is that a Chinese registration certificate is not legally prohibited, but it does not sit on the current reference list. A filing built on it should be handled as evidence reinforcement rather than evidence substitution, with written confirmation from EDE serving as the basis for decisions.

• An NMPA registration certificate is not legally barred from a UAE filing, but it is not on the current list of reference authorities EDE references.
• The filing should be organised as evidence reinforcement, not evidence substitution, with the degree of acceptability of the Chinese certificate confirmed in writing by EDE before money is spent.
• Two pillars matter most when only a Chinese certificate exists: the GMP certificate under Article 6(1)(f) and a free sale or registration certificate from the country of origin attested by the UAE embassy.
• The classification letter, obtained in 10 working days, determines the regulatory class first and lets the evidence investment be sized accordingly.

2. Legal basis

The framework for filing with an NMPA-only certificate rests on Article 6 of Federal Decree-Law No. 38/2024 and on two EDE service pages, summarised below.

3. Expert insights

Insight 1: The choice among the three routes is essentially trading time for certainty. Route one is to first obtain a reference-country approval, such as CE marking or an FDA 510(k), and then file in the UAE; it offers the highest certainty at the cost of a longer overall cycle, with industry practice running from zero preparation to formal market entry at 6–18 months (practical estimate). Route two is to file directly with the NMPA certificate plus a complete technical file, advancing on the strength of written confirmations; it suits companies that already hold mature documentation for overseas markets. Route three is to obtain the classification letter first and use the 10-working-day service to confirm the class and whether a marketing authorization is required, then decide the scale of investment. Our rule for choosing: lower-risk products take route two plus route three, while higher-risk products prioritise building reference-country evidence.

Insight 2: When only a Chinese certificate exists, item (f) and the CFS are the two hardest pillars. Article 6(1)(f) allows the GMP certificate to be issued by the competent authority of the country of origin, which preserves a workable channel for Chinese manufacturers. The EDE service page, for its part, requires a free sale or registration certificate issued by the competent authority of the country of origin and attested by the UAE embassy. Together, these two documents constitute a complete demonstration that the product is legally on the market in its country of origin and that its manufacturing quality is under control. If either one is missing, the reliance review loses the very object it is supposed to assess.

Insight 3: In the gap period, uncertainty should be converted into written conclusions. The Executive Regulations under the Decree-Law have not yet all been issued, Article 6(1)(h) reserves further conditions, and the reference authority list is being updated. We hold to one action: before investing in translation, notarisation and embassy attestation costs, obtain a written response from EDE on whether the Chinese registration certificate can serve as a supporting document. In parallel, the importer, distributor and lead responsible entity arrangements under Article 22 must be settled during the filing stage, so that an approved product does not end up with no one bearing vigilance and whole-lifecycle management duties.

4. Practical recommendations

• Classify first: use the classification letter to confirm the class and whether a marketing authorization is required, then size the evidence investment.
• Complete the country-of-origin document set: a free sale or registration certificate issued by the competent authority and attested by the UAE embassy, plus a GMP certificate prepared under one of the three sources in item (f).
• Assemble the complete technical file, covering risk management, performance and safety data, instructions for use and labelling, checked line by line against the required documents on the EDE service page.
• For high-risk products, prioritise adding a reference-country approval, upgrading the object of the item (c) assessment from a country-of-origin approval to a reference-country approval.
• Start translation and notarisation only after written confirmation from EDE has been obtained, so the attestation chain is not completed before discovering the evidence is not accepted.
• Budget official fees (application fee AED 100, registration fee AED 5,000) separately from practical-estimate expenditure, with translation, notarisation and agency services counted additionally (practical estimate).

5. Verification checklist

• □ The EDE classification letter has been obtained, confirming the regulatory class and whether a marketing authorization is required.
• □ The NMPA registration certificate is within its validity period and the models and specifications it covers extend to the products to be filed.
• □ The free sale or registration certificate issued by the competent authority of the country of origin has completed UAE embassy attestation.
• □ The issuing body of the GMP certificate satisfies Article 6(1)(f) and the certificate is within its validity period.
• □ Written confirmation or an official acceptance response from EDE has been obtained on the degree to which the Chinese certificate can be relied on.
• □ The risk management material, performance data, instructions for use and labelling in the technical file are complete against the EDE service page list.
• □ The importer, distributor and lead responsible entity arrangements required by Article 22 have been started in parallel.

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