Who Regulates Medical Devices in the UAE: Legal Basis and Timeline for EDE Replacing MOHAP

1. Key takeaways

As of January 2, 2025, the competent authority for the registration, classification, pricing and vigilance of medical devices in the United Arab Emirates is the Emirates Drug Establishment (EDE), and the relevant functions previously exercised by the Ministry of Health and Prevention (MOHAP) have been transferred accordingly. This institutional switch rests on two layers of legal basis: Federal Decree-Law No. 28/2023 established the EDE and granted it powers over licensing, pricing, vigilance and traceability, while Federal Decree-Law No. 38/2024 was issued on October 1, 2024, published in the Official Gazette on October 14, 2024, entered into force on January 2, 2025, and repealed Federal Law No. 8/2019 with effect from that date. Existing certificates remain valid for the validity period stated on them, and the recipient of new applications, renewals, variations and official correspondence should uniformly be changed to the EDE.

• The EDE is now the single competent authority for medical device registration, classification, pricing and vigilance in the UAE.
• The legal basis for the switch is the combination of Federal Decree-Law No. 28/2023 and Federal Decree-Law No. 38/2024.
• Federal Law No. 8/2019 was repealed with effect from January 2, 2025.
• Existing certificates continue to be valid for their stated validity period, but all new filings go to the EDE.

2. Legal basis

The table below summarises the legal instruments and the current official service terms that govern this change of authority, together with the specific provisions and key points that companies should verify against their own certificate records.

3. Expert insights

Insight 1: The substance of the institutional switch is a replacement of the legal basis, not merely a change of recipient department. The filing habits built up during the MOHAP era rest on Federal Law No. 8/2019, whereas the current obligations derive from the 181-article system of Federal Decree-Law No. 38/2024. Our judgement is that any arrangement involving applicant eligibility, the licence holder entity, the agent structure and vigilance obligations should be re-benchmarked for compliance against the new decree; it is not sufficient to simply replace the authority name in the letterhead of correspondence. The reason lies in Article 22, which introduces requirements on the number of importers and distributors and the lead-institution mechanism — an arrangement that did not exist under the former law, so that retaining the old structure would directly constitute non-compliance.

Insight 2: The transition period is a period for rectification, not a period of exemption. Federal Decree-Law No. 38/2024 entered into force on January 2, 2025 and provides a 1-year transition period, which the Cabinet may decide to extend. Our judgement is that the transition period protects the status of arrangements that were lawfully established under the former law; it does not protect a failure to rectify after the new law has entered into force. Once the transition period expires, the fine range for establishments under Article 160 of AED 1,000–1,000,000 will apply without distinction. The order of rectification should follow the degree of exposure to violations: first resolve the absence of certificates and expired certificates, then resolve the licence holder and agent structure, and finally address labelling and the vigilance system.

Insight 3: The basis for judging the validity of existing certificates is the stated validity period plus the stated matters, not the issuing authority. Certificates should not be treated on a one-size-fits-all basis according to whether they were issued by MOHAP or by the EDE. Existing certificates remain valid for the validity period stated on them, but once any matter stated on the certificate changes — relocation of the manufacturing site, a change of MAH, or an extension of specifications and models — the certificate no longer falls within the continuation of existing status, and a variation or re-approval procedure under the new law should instead be followed. In practice, the certificate ledger should be checked line by line against the validity period and the stated matters, rather than processing certificates in batches by year of issue.

4. Practical recommendations

• Establish a ledger covering all certificates valid in the UAE, recording line by line the certificate number, issuing authority, expiry date of the validity period, MAH and licensed matters.
• Uniformly change the recipient of new applications, renewals, variations and vigilance reports to the EDE, and retain submission receipts and acceptance numbers.
• During the transition period, complete a re-examination of licence holder qualifications: the marketing office or medical warehouse must hold a valid licence, and the MAH and manufacturing site must first be registered with the EDE.
• Recalculate schedules according to the current EDE service terms: classification of 10 working days and marketing authorization of 45 working days, with document preparation time added on top (practical estimate: from zero preparation to formal market entry, 6–18 months).
• Start preparing the documentation in advance for certificates expiring and requiring renewal within 2026, to avoid a concentration of filings at the end of the transition period that would leave a gap in certificate coverage.
• Conduct a compliance review of already signed local agent and distribution agreements, confirming that they can carry the allocation of import, distribution and vigilance duties under the new law.

5. Verification checklist

• □ The issuing authority, expiry date and stated matters of all certificates valid in the UAE have been confirmed.
• □ The submission channel, accepting department and form of receipt for new applications and renewals have been confirmed as based on the EDE.
• □ Registration of the MAH and manufacturing site with the EDE has been completed, or a registration schedule has been set.
• □ The marketing office or medical warehouse holds a valid licence whose business scope covers the products to be filed.
• □ The number of importers and distributors and the lead-institution arrangement have been reviewed against Article 22 for conformity.
• □ A rolling 12-month renewal reminder mechanism has been established based on certificate validity periods.
• □ Written records of proactive rectification during the transition period (receipts and correspondence) have been retained.

Further reading: Article 02 “Scope of Federal Decree-Law No. 38/2024: Which Category of Medical Products Covers Medical Devices”; Article 09 “From Federal Law No. 8/2019 to Decree-Law No. 38/2024: Repeal, Amendment and the Validity of Existing Certificates”; Article 37 “The Full Timeline: Beyond 10/45/3/2 Working Days, How Much Lead Time Companies Really Need to Allow”.

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