🇦🇪United Arab Emirates Medical Device Regulations

Classification of a Product - Guidelines

Detailed guidelines for product classification based on presentation, composition, use, and design. Determines if MOHAP registration is required.

Registration of Medical Equipment

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

Registration of a Manufacturer of Medical 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.

Renewal of Registration of Medical Equipment

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

Issue of Permit to Import Medical Equipment

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.

Classification of a Product

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.

Licensing of a Pharmaceutical/Medical Device Manufacturing Facility

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

MOHAP Registered Medical Devices Database

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

Federal Law Regarding Medical Products, the Pharmacy Profession and Pharmaceutical Establishments

Primary federal law governing medical products including medical devices in the UAE. Establishes MOHAP authority and registration requirements.