United Arab Emirates (UAE) Authorized Representative (AR)

For foreign manufacturers without a legal entity in the United Arab Emirates (UAE), it is mandatory to appoint a licensed UAE-based company as their Authorized Representative (AR) or Marketing Authorization Holder (MAH) for medical devices and IVDs in UAE. Navigating the UAE medical device registration process is essential for manufacturers seeking access to the dynamic market of the United Arab Emirates.

Qserve partners with a trusted local regulatory expert in the UAE to act as your license holder and manage all regulatory obligations. The authorized representative acts as your liaison with the Ministry of Health and Prevention (MOHAP) and oversees compliance with the UAE medical device approval process.

Liaison with MOHAP

Your AR serves as your official point of contact with MOHAP. All regulatory communication - before, during, and after product registration - is managed through the AR. This includes handling inquiries and responding to authority requests. Efficient communication avoids delays in approvals or compliance issues.

Compliance

The AR ensures all devices meet applicable UAE regulations and standards. This includes verifying conformity with local regulations, ensuring correct product classification, and maintaining compliance with evolving regulatory frameworks.

Registration

The AR manages the entire product registration and manufacturer registration process. This involves preparing and submitting applications via MOHAP systems, coordinating regulatory submissions and tracking progress. Proper handling of registration is essential for timely market entry.

Documentation

Your AR is responsible for preparing, reviewing, and submitting all required regulatory documentation in accordance with UAE guidelines. This includes Quality Management System (QMS) documentation, technical files, product labelling, product claims and Instructions for Use (IFU). All registration documents and labelling should be provided in English, which is the accepted language for medical device documentation in the UAE.

Market Access

Beyond registration, the AR ensures that all necessary licenses are obtained to legally import and distribute devices within the UAE. This includes coordinating import permits and verifying distributor requirements.

Post-Market Surveillance

The AR fulfills post-market surveillance requirements such as collecting and reporting adverse events, handling complaints and coordinating corrective actions when required. The AR ensures that all post-market surveillance activities are conducted in line with MOHAP regulations, safeguarding both patient safety and regulatory compliance.