From Federal Law No. 8/2019 to Decree-Law No. 38/2024: Repeal, Amendment and Existing Certificate Validity

1. Key takeaways

The legal basis of medical device regulation in the UAE has passed through three stages: Federal Law No. 8/2019 was adopted on December 19, 2019 and entered into force in January 2020; it was subsequently amended by Federal Law No. 11/2023, forming an intermediate transitional state; and it was ultimately repealed when Federal Decree-Law No. 38/2024 entered into force on January 2, 2025, with a 1-year transition period running from the effective date. Our conclusion is that what was repealed is the legal basis, not the certificates. Certificates originally issued by MOHAP remain valid for the validity period stated on them, but the applicant eligibility, agent structure, vigilance and labelling obligations to which those certificates are attached must be realigned with the new decree; otherwise they will not pass review at renewal or variation.

• Federal Law No. 8/2019 was adopted on December 19, 2019 and entered into force in January 2020.
• Federal Law No. 11/2023 amended the former law, forming an intermediate transitional state.
• Federal Decree-Law No. 38/2024 repealed the former law with effect from January 2, 2025, with a 1-year transition period.
• Existing MOHAP certificates remain valid for their stated validity period, but the attached obligations must be realigned with the new decree.

2. Legal basis

The table below traces the three stages of the legal sources, from the original law through its amendment to the repealing decree, together with the service-page terms that now govern the entity requirements behind every certificate.

3. Expert insights

Insight 1: The repeal date and the start of the transition period are the same day, but their legal meanings differ. Federal Law No. 8/2019 ceased to apply as of January 2, 2025, and from the same date a 1-year transition period was granted. Our judgement is that the repeal means that from then on there is no longer any possibility of “applying for a new certificate under the former law”, whereas the transition period is an arrangement for the continuation of legal status already obtained under the former law. Only by keeping these two matters apart can the question companies care about most be answered: can the old certificates still be used — yes, but only within the stated validity period and the stated matters.

Insight 2: The amended state under No. 11/2023 does not constitute an independent compliance basis, but it affects the finding of facts. Our judgement is that the legality of filings completed before January 2, 2025 under the amended former law should be judged by the legal source in force at the time, and cannot be retrospectively negated by the new law. After the new law enters into force, however, the rights and obligations attached to those certificates must be performed under the new law. The handling principle is therefore “validity continues, obligations update” — the certificates remain valid, while the holder’s systems, vigilance, labelling and agent arrangements are performed under No. 38/2024.

Insight 3: The real risk points of existing certificates appear at the two actions of “renewal” and “variation”. Our judgement is that existing certificates carry very low risk while left untouched; the risk concentrates at the moment an application must be submitted to the EDE. The reason is that renewal and variation trigger a re-examination of the eight conditions of Article 6, including applicant eligibility (a), the GMP certificate (f) and labelling (g). If the company still holds the entity structures and document formats of the former law during this period, the renewal application will be sent back for correction. In addition, the cancellation grounds of Article 17 (local products not placed on the market within 2 years / 1 year after approval) continue to apply under the new law, so existing certificates for products never actually sold also face lapse.

4. Practical recommendations

• Register all existing certificates line by line by “stated validity period plus stated matters”, marking the renewal and variation plans for the next 24 months.
• Before submitting a renewal or variation, complete one round of obligation-alignment self-checks under No. 38/2024, covering applicant eligibility, GMP certificate scope, labelling and the vigilance system.
• Scan and archive the original MOHAP certificates, approvals and historical correspondence as evidence of the chain of legality.
• For existing certificates whose products have not actually been sold for a long time, assess the cancellation risk under Article 17 and decide whether to resume supply or to wind them down proactively.
• Re-sign or supplement the existing agreements with local agents, setting out clearly the allocation of import, distribution and vigilance duties under the new law.
• Track whether the Cabinet decides to extend the transition period, and adjust the order of rectification and renewal accordingly.

5. Verification checklist

• □ The issuing legal source, validity period and stated matters of all existing certificates have been confirmed.
• □ The certificate ledger has been matched against the renewal and variation plans for the next 24 months.
• □ A self-check of the eligibility and qualifications of certificate holders has been completed under No. 38/2024.
• □ It has been confirmed that the GMP certificate scope covers the products whose registration is to be maintained.
• □ It has been confirmed that the labelling and instructions for use satisfy Article 6(1)(g) and the EDE labelling guidance.
• □ The non-marketing cancellation risk under Article 17 has been verified and dealt with.
• □ Archived scans of the original MOHAP certificates and historical approvals have been retained.
• □ It has been confirmed that the local agent agreements reflect the allocation of duties under the new law.

Further reading: Article 01 “Who Regulates Medical Devices in the UAE: The Legal Basis and Timeline of the EDE Replacing MOHAP”; Article 10 “How to Use the One-Year Transition Period: Effective Date, Rectification Obligations and the Start of Penalties”; Article 21 “The EDE Medical Device Filing Document List: The Verification Order of the Official Service-Page Documents”.

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