Overview

United Arab Emirates (UAE), a prominent GCC member nation, has an advanced healthcare system. Its market potential is proven and consistently on a rise. Governed by Drug Control Department of the Ministry of Health (DCD MOH), Medical Devices in UAE are classified into 4 risk-based classes (Class I, IIa, IIb, and III). Centralized governance and linguistic barriers are major hinderances for device approvals in the region, along with linguistic complexities and lack of efficient communication channels with the health authorities.

With an exclusive delivery center in Dubai, Freyr holds an authoritative hold on UAE Medical Device market, and outlines the Device Classification apart from decoding the guidance regulations for better compliance. We support clients in document compilation as per standards for right-first-time approach and thus ensure quick approvals. Freyr offers complete range of Regulatory services pertaining to successful device marketing.

 

UAE Market Entry for Medical Devices - Process Flow

UAE Medical Device Regulations

 

 

Freyr Expertise

  • Medical Device Classification
  • Local Authorized Agent Representation
  • Document Compilation and Submission
  • Review of Device Safety and Efficacy
  • Post-Market Surveillance

 

Summary

S. No

Regulatory Parameter

UAE

1

Regulatory Authority

Drug Control Department of the Ministry of Health (DCD/MOH)

2

Regulation

UAE Medical Devices Registration Guideline

3


Risk Classification
(As per GHTF reference country)

Class I

Class IIa

Class IIb

Class III

4

Regulatory Pathway

Product Registration

5

Authorized Representative

Required

6

Fee payable

 

7

QMS Requirement

ISO 13485

8

Assessment of Technical Data

Medical Device Registration Committee

9

Validity of License

5 Years

10

Labelling Requirements

Annex 2 (2.5) of UAE Medical Devices
Registration Guideline

11

Submission format

Paper

12

Final Outcome

Registration Certificate

13

Timelines

6 - 9 Months

14

Language

English