United Arab Emirates medical device regulations

Successor primary law for medical products (including Medical Equipment) in the UAE, repealing Federal Law No. 8 of 2019 (Article 180) and in force from 2 January 2025 (Article 181). Establishes the Emirates Drug Establishment (EDE) as the federal regulator (marketing approvals, licensing, import permits, pharmacovigilance) with the Ministry and local health authorities. The official English expression is published in full on the UAE legislation portal (verified in full — Parts One to Nine, 181 articles), but the portal returns a Cloudflare 403 to ingestion clients and the EDE-hosted Arabic original PDF has a visually scrambled text layer that is not publishable. This is therefore a blocked exact source, not a virtual corpus view.

MOHAP service guideline for the classification-of-a-product service, which determines whether a product requires MOHAP registration and in which class (UAE uses Classes I-IV). Covers the classification-letter terms (validity three years, not a registration certificate), device-specific conditions in items 11.1-11.10 (accessory lists, grouping, laboratory reagents, professional-restricted clearance, software processing patient data), letter formats, and the twelve required documents (country-of-origin certificates, product catalogue for medical devices, artworks, MSDS). After the transfer of medical-product services to the Emirates Drug Establishment the official copy is served by the EDE document portal (title carries the official typo "GUIDLINES"); the original mohap.gov.ae host resets TLS connections from our verification egress and is unreachable. Ingested in full.

Product classification service to determine if registration by MOHAP is required. UAE uses 4-class system (Class I, II, III, IV). Higher risk devices require additional documentation.

Registration service for medical equipment for import and trading in UAE. Requires valid licensed medical warehouse or marketing office. Registration fee: AED 5,000.

Licensing for pharmaceutical and medical device manufacturing facilities. License fee: AED 50,000. Biomedical engineer may replace pharmacist for medical device-only facilities.

Import permit for local agents with valid medical store license. FANR permit required for ionizing radiation devices. Batch Release Certificate required for blood/plasma/tissue products.

Registration of manufacturing sites for medical products. Requires valid ISO 13485 certificate and business/manufacturing license from country of origin. Renewal every 5 years.

Procedures for renewing medical equipment registration. Registration must be renewed before expiration to maintain market authorization.

Public database of medical devices registered with MOHAP. Searchable by product name, manufacturer, or registration number.

Primary federal law governing medical products including medical devices in the UAE (2019). REPEALED by Federal Decree-Law No. 38 of 2024 (Article 180), which entered into force 2 January 2025 — see the successor row. This is a real binding instrument, not a non-document page; it is source-blocked because the stored MOHAP URL points to Cabinet Resolution No. 90 of 2021 rather than the law itself and mohap.gov.ae resets TLS connections from verification egress. The repeal is evidenced by Article 180 of the successor Decree-Law on the official UAE legislation portal and by the EDE legislations register, which no longer lists Law 8/2019 among the laws in force.