What Documents Are Needed for EDE Registration in the UAE?

To obtain marketing authorization for a medical device in the UAE, applicants must submit the required administrative and product documentation through the Emirates Drug Establishment (EDE). Although many people still refer to the process as MOHAP registration, medical device marketing authorization is now administered by EDE. Before applying for product registration, the Marketing Authorization Holder (MAH) and the manufacturing site must also be registered with EDE, as applicable.

Quick Overview

·        What is it: A regulatory approval that allows a medical device to be imported and traded in the UAE.

·        Where it applies: Required for any medical equipment sold, distributed, or marketed within the country.

·        Why it matters: Without this authorization, medical devices cannot legally enter the UAE market.

·        A limitation to note: The application must go through a UAE-licensed marketing office or medical warehouse — foreign manufacturers cannot apply directly. The required documents may vary depending on the medical device and the applicable regulatory pathway.

Who Handles Medical Device Registration in the UAE Now?

Medical device marketing authorization was formerly processed through MOHAP. Under Federal Decree-Law No. 38 of 2024, the Emirates Drug Establishment (EDE) became the federal authority for regulating medical and pharmaceutical products, and it formally took over this service from MOHAP on December 29, 2025. New applications are submitted through the EDE portal (ede.gov.ae), not the previous MOHAP eServices system. Certificates issued by MOHAP before the transition remain valid until their stated expiry date.

What Are the Documents Required for Registration?

Medical device registration in the UAE requires applicants to submit documents that identify the manufacturer, the Marketing Authorization Holder, and the medical device being registered. According to the Emirates Drug Establishment, applicants must complete the required establishment registrations before applying for marketing authorization for a medical device.

The exact documentation requested may differ depending on the product. However, applicants should generally be prepared to provide documentation relating to the manufacturer, the product, and any supporting information requested during the evaluation process.

What documents are required for MOHAP registration?

Medical device registration in the UAE generally requires establishment registration, manufacturer and product information, labeling, Instructions for Use (IFU), and any additional supporting documentation requested by the Emirates Drug Establishment. The exact requirements depend on the medical device and the applicable registration pathway.

Why Must the Marketing Authorization Holder Be Registered First?

The Marketing Authorization Holder (MAH) is the entity responsible for placing a medical device on the UAE market. According to the Emirates Drug Establishment, the MAH must be registered before submitting a medical device marketing authorization application.

This requirement ensures that EDE can identify the legal entity responsible for regulatory compliance, communication with the authority, and maintaining the product throughout its lifecycle. If the manufacturer is located outside the UAE, an appropriately registered local entity may act as the Marketing Authorization Holder in accordance with EDE requirements.

What Product-Specific Documents Are Required?

Each device application must include detailed product information: description, formulation, sizes, models, accessories, intended uses, side effects, contraindications, warnings, precautions, and usage guidelines. Supporting materials such as packaging photos, brochures, and usage manuals are also required. A certificate of quality conformity — such as CE marking, 510(k), or PMA — must match the device's risk classification (Class I, II, III, or IV).

Additional product items typically requested include:

·        One product sample, where applicable

·        Certificate of analysis (depending on device type)

·        External and internal packaging and inserts

·        EC Declaration of Conformity confirming the product meets the Medical Equipment Manual specifications

Are There Additional Requirements for Higher-Risk Devices?

Devices classified as Class III or Class IV carry additional documentation because they present greater risk to patients. Applicants for these categories must submit safety and efficacy data alongside the standard product file. Devices manufactured using animal-derived materials also require a separate certificate of conformity confirming safe sourcing and processing.

What Is the Difference Between Class I and Class III/IV Device Documentation?

How Long Does Registration Take and What Are the Fees?

FEDE states an official service completion time of 45 working days for medical device marketing authorization. The application fee is AED 100, and the registration fee is AED 5,000. Once approved, the marketing authorization certificate is valid for five years from the date of committee approval. Industry sources note that first-time registrations, particularly for Class III or IV devices, can take considerably longer in practice due to document review cycles and requests for additional information.