Certification Introduction
Market access for medical devices in the United Arab Emirates is regulated by the UAE Ministry of Health and Prevention (MOHAP). The process follows the unified technical specifications of the Gulf Cooperation Council (GCC), and certification is managed in a classification system based on product risk levels from Class I to Class IV. Approved products receive a 5-year marketing authorization, which allows circulation across all GCC member states. Starting from 2023, a special review requirement for digital medical devices has been introduced.
Laws and Regulations
- Core supervision is governed by the medical device marketing authorization rules issued by MOHAP
- Complies with the unified GCC medical device technical regulation, and references the harmonization framework of the International Medical Device Regulators Forum (IMDRF)
- New regulatory requirements for the digital health sector were added in 2023, clarifying data security compliance obligations for AI medical software and telemedicine devices For specific clauses, please visit the official MOHAP website to check the latest requirements.
Technical Requirements
- Products must meet the basic safety and performance requirements for medical devices issued by the Gulf Standardization Organization (GSO), and manufacturers must hold a valid ISO 13485 quality management system certificate
- Low-risk Class I products only need to provide basic technical documents and a declaration of conformity; high-risk Class III and IV products need to additionally provide approval certificates from major markets such as CE/FDA, and clinical evaluation/equivalence documents
- Labels and instructions for all marketed products must be provided in both Arabic and English to meet localization labeling requirements
- AI medical software and remote monitoring devices need to additionally submit data encryption schemes and privacy protection compliance documents, and some products are required to supplement climate adaptability test reports
Certification Process
Appoint a local authorized representative in the UAE, complete product risk classification, prepare a full set of compliant technical application documents, submit the registration application via the Gulf Conformity Tracking System (GCTS) or the official MOHAP electronic platform, and wait for the regulator to complete the initial document review. After passing the initial review, the application enters the expert technical evaluation stage, where applicants need to supplement materials or complete specified product testing as required. After approval, pay the registration fee to obtain the marketing authorization certificate, and complete post-market adverse event monitoring and registration renewal as required after certification.
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