Medical Devices — United Arab Emirates

The market access of medical devices in the United Arab Emirates (UAE) is regulated by the Emirates Drug Authority (EDE) (previously overseen by the Ministry of Health and Prevention, MOHAP). It generally follows the unified technical specifications of the Gulf Cooperation Council (GCC), and implements hierarchical management divided into Category I to IV based on product risk levels. After obtaining national access approval from EDE, it is still necessary to coordinate with the local health authority for local institutional filing and product association. In addition, for equipment involving specific risks such as ionizing radiation, special permits from authorities such as the Federal Nuclear Regulatory Authority are also required, jointly forming a comprehensive compliance framework of "unified national registration, local zoned supervision, and special classified approval".

Federal Decree-Law No. 28 of 2023 Federal Decree-Law No. 38 of 2024 Issuance of Marketing Authorization for a Medical Device Classification of a Medical Product It is generally aligned with the unified medical device technical regulations of the Gulf Cooperation Council (GCC), please refer to the latest announcements on the official EDE website for specific provisions.

UAE registration is divided into four categories I, II, III, IV from low to high product risk, and different categories correspond to differentiated compliance and technical control requirements. Mandatory classification application: Before submitting marketing authorization for any medical device, a classification application must be submitted through the official EDE system. The registration process can only proceed after obtaining the official classification confirmation letter. Manufacturer site registration (mandatory precondition): Overseas manufacturers must complete EDE site registration before product registration. The validity period of site registration is 5 years, and renewal must be completed before expiration. Products must comply with the basic safety and performance requirements for medical devices, and relevant test reports must be issued by ILAC-accredited laboratories. If the product is intended for use by non-professional medical personnel, Arabic-language labels and instructions must be provided. Some products require an additional climate adaptability test report to ensure stable performance in the high temperature and high humidity environment of the UAE. If a medical device contains a wireless transmitting module, in addition to complying with EDE regulations, it must also obtain radio equipment type approval from the UAE Telecommunications Regulatory Authority. A post-marketing adverse event monitoring and feedback mechanism must be established, regular safety update reports shall be submitted in accordance with the requirements of EDE and local health authorities, to continuously fulfill post-marketing compliance obligations.