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The regulatory authority for medical devices in the United Arab Emirates

The Emirates Drug Establishment (EDE) is an independent professional regulatory body established by the Federal Government of the United Arab Emirates on September 29, 2023. It came into effect on January 2, 2025, in accordance with Federal Decree-Law No. 38 of 2024. EDE is fully responsible for the regulation of drugs and medical devices in the United Arab Emirates. In February 2026, all 44 core regulatory services under the former Ministry of Health and Prevention (MOHAP) were transferred to EDE, marking the entry of the United Arab Emirates' medical product regulatory system into a new stage of centralization and professionalization.

Regulatory Authority's Official Website Link:https://mohap.gov.ae/en/w/registration-of-a-medical-equipment

Database link:https://mohap.gov.ae/en/w/registration-of-a-medical-equipment

egulatory regulations

Medical Device Registration Guideline 2019

The 8th law of 2019 is an important legal basis for the regulation of medical devices, applicable to drugs, medical devices, and health-related consumer products.

The European Medical Device Directive (Medical Device Regulation, MDR)

Risk Level Classification of Medical Device and IVD Products

The UAE Ministry of Health and Prevention (MOHAP) classifies medical devices in accordance with the European Medical Device Regulation (MDR) and the European Medical Device Harmon. According to the risk level from low to high, medical devices are divided into four categories: Class I, Ⅱ, Ⅲ, Ⅳ. In vitro diagnostic devices (IVD) are classified as A, B, C, and D.

Entry requirements

① The product registration application form must be filled out, signed and stamped by the company.

② Copy of the factory's valid registration certificate

③ A free sale/registration certificate issued by the competent authority of the country of origin, certified by the Embassy of the United Arab Emirates

④ Copy of the authorization signed by the company and the distributor/representative

⑤ Quality certification / Marketing authorization certificate, such as EC, 510 (K), PMA, depending on the classification of the equipment, namely Class I, II, III, and IV.

⑥ Requirements for post-listing monitoring.

⑦ Copies of product registration certificates from other countries.

⑧ Product information, including description, formula, type, size, model, accessories, usage, side effects, contradictions, warnings, precautions, usage guide, cover photo of the packaging, manual and user manual.

⑨ Provide the laboratory requirements and analyses, as well as the pricing for certain medical equipment.

Provide three samples (depending on the type of equipment), analysis certificates (depending on the type of equipment), inner and outer covers, and manuals.

⑪ The company confirms that the equipment complies with the specifications outlined in the "Medical Equipment Manual" (CE Conformity Declaration).

Safety and efficacy data (for Class III and IV products).

⑬ Special requirement: Certificate of conformity for animal product manufacturing equipment.

Registration Language

English.

Registration process, duration and official fees

1. Registration process

(1) Confirm whether the product is a medical device

Submit official confirmation: The process takes 30 working days.

(2) Selection of registration methods

(3) Preparation of registration information

The materials that need to be prepared are divided into three categories:

System documents: GMP certificate or ISO certificate issued by an authorized institution

Documents requiring verification: POA, FSC, business license, production license, ISO 13485

Other registration information

(4) Prepare the registration application materials

(5) Submit the registration application

(6) Official Review: The review period is 3 to 6 months.

(7) Obtaining the certificate: The validity period of the certificate is 5 years.

2. Registration period and official fees

(1) Classification of Products

Service fee: 500 AED

Service completion time: 30 working days

(2) Registration of medical product manufacturers

Application fee: 100 AED

Registration fee: 10,000 AED

Service completion time: 2 to 4 weeks

(3) Registration of Medical Equipment

Application fee: 100 AED

Registration fee: 5000 AED

Service completion time: 3 to 6 months

Chapter 3 FAQ

Q: What national registration certificates are available to speed up registration in UAE?

A: The registration process can be simplified for medical devices that have been obtained certificate from the European Union, the United States, Australia, Canada or Japan.

Q: How long is the registration certificate in UAE valid?

A: The registration of medical devices is valid for five years, and should be renewed at least 90 days before the expiration of the registration of the device, the PMS system needs to be established, and the renewal service needs 15 working days to complete. The application fee is 100AED, and the renewal service fee is 2500AED.

Q: What are the requirements for labels and instructions?

A: Labels and instructions should be in Arabic or English and ensure that the information is accurate and legible. For Arabic users, an Arabic translation should be provided to ensure that users can correctly understand the product information and use methods. Labels and instructions should clearly indicate the potential risks, contraindications, use methods, maintenance and other warnings and precautions of medical devices, high-risk medical devices need to provide more detailed warning information.

Q: Is local testing required for registration in UAE?

A: For certain high-risk or specialized types of medical devices, MOHAP may require sample testing. Testing will be conducted at a MOHAP-designated laboratory to verify the performance, safety, and effectiveness of the product.

Q: Is it necessary for the regulatory authority to classify risk levels before registration in UAE?

A: Yes. The official fee for classification and identification of risk levels by the Regulatory Authority is 500AED and the time is 30 working days.

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