Chapter 1 MOHAP of the United Arab Emirates administration information abstract

1. Administration and Abstract

Ministry of Health and Prevention (MOHAP) is responsible for the development of medical device supervision policies, regulations and standards, but also undertake the market access approval of medical devices, quality supervision and many other responsibilities.

In addition, local Health authorities such as the Dubai Health Authority (DHA) and the Abu Dhabi Health Authority (HAAD) also play an important supervision role in their respective jurisdictions and work together to ensure the effective implementation of regulations.

2. Administrative Regulation

Medical Device Registration Guideline 2019.

Regulation No. 8 of 2019 is an important legal basis for the supervision of medical devices and applies to medicines, medical devices and health-related consumer products.

Medical Device Regulation，MDR.

3. 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.

4. Entry requirements

① The application form for product registration should be filled in, signed and sealed by the company.

② Copy of registration certificate in valid of the factory.

③Free sale/registration certificate issued by the competent authority of the country of origin must be certified by the UAE Embassy.

④ Authorized copy signed by the company and the dealer/representative.

⑤Certificate of Quality Conformity/Marketing Authorization e.g. EC, 510 (K), PMA depending on the classification of the equipment i.e. Class I, II, III, IV.

⑥Post-market supervision requirements.

⑦ Copies of product registration certificates from other countries.

⑧Product information, including description, formula, type, size, model, accessories, intended use, side effects, contradictions, warnings, precautions, instructions for use, packaging cover photos, brochure and user manuals.

⑨Provides laboratory requirements and analysis, as well as pricing for certain medical devices.

⑩Provide three samples (according to the type of equipment), certificate of analysis (according to the type of equipment), inside and outside cover and manual.

⑪The Company confirms that the device complies with the specifications of the Medical Device Manual (CE Declaration of Conformity).

⑫Safety and efficacy data (for Class III and IV products).

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

5. Registration Language

Arabic.

Chapter 2 Registration Flow、Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

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.