UAE MOHAP Regulatory Requirements for Medical Devices and IVDs

UAE’s Medical Device Market

United Arab Emirates (UAE) has established itself as a healthcare hub within the Middle East even though it manufactures very few devices domestically. The medical device market continues to grow along with demand for imported medical technology. UAE’s new medical device regulation, which went into effect January 1, 2025, is designed to make the market more accessible to foreign device manufacturers while ensuring the safety and performance of devices.

Regulatory authority

Medical devices sold in UAE are regulated by the Registration and Drug Control Department (DCD), a division of the Ministry of Health and Prevention (MOHAP). MOHAP enforces regulatory requirements for medical devices, pharmaceuticals, and the pharmacy profession according to Federal Decree-Law No. 38 of 2024, which came into force in January 2025. A one-year transition period began on the date of application.

Device classification

UAE classifies medical devices according to their risk profile. There are four classifications: Class I, II, III, and IV, with Class IV being the highest risk. IVDs are similarly classified by risk into four tiers: Class A, B, C, and D. Registration documentation and clinical data requirements for your device are based on risk classification.

Registration process

Medical devices must be registered with MOHAP and undergo regulatory review to ensure the device meets safety and performance requirements. Registration documentation includes a registration application; QMS certificate or other proof of QMS system; Certificate of Free Sale (CFS); technical documentation; and labeling in Arabic. High-risk devices may also require clinical data and testing or certification to international safety standards. Foreign manufacturers should include a Power of Attorney that demonstrates the Local Agent is authorized to act on their behalf. You must also pay registration fees depending on your device classification. After regulatory review, which can take several months for higher risk devices, MOHAP will issue a registration certificate. Registration must be renewed every five years.

Quality management system (QMS) requirements

MOHAP does not enforce its own QMS standard or Good Manufacturing Practice (GMP) requirements. Device manufacturers must instead provide proof of a QMS that adheres to international standards, such as an ISO 13485:2016 certificate.

In-country representation

Manufacturers located outside UAE must appoint an in-country representative based in UAE called a Local Agent or Local Representative. The Local Agent submits your registration application to MOHAP, acts on your behalf to facilitate the registration process, and ensures compliance with post-market requirements.

Expert Guidance for Your UAE Medical Device Registration

Considering UAE registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry. Contact us to learn more about MOHAP medical device registration