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UAE Medical Device Registration: A Step-by-Step Guide

UAE Medical Device Registration Guidelines 

1. Regulatory Authority: 

2. Classification of Medical Devices: 

MOH UAE Registration Documents for Medical Device 

1. Application Form 

2. Product Documentation 

3. Certificate of Free Sale (CFS) 

4. Quality Management System (QMS) Documentation 

5. Power of Attorney 

6. Conformity Assessment Documents 

4 Steps for Medical Device Registration Process in the UAE 

1. Pre-market Approval 

2. Product Evaluation 

3. Registration Fees 

4. Issuance of Registration Certificate 

UAE Medical Device Registration Timeline 

1. Initial Application Submission: 

2. Review Process: 

3. Approval and Issuance of Registration: 

United Arab Emirates Medical Device Regulations 

Conclusion 

Frequently Asked Questions

1. How long does the UAE medical device registration process take? 

2. Do foreign manufacturers need a local representative for registration in the UAE? 

3. Are there specific requirements for labeling medical devices in the UAE? 

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