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United Arab Emirates Medical Device Registration

Ministry of Health and Prevention (MOHAP) approval timelines and requirements

2-3 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

UAE Authorized Representative

United Arab Emirates Medical Device Registration Overview

United Arab Emirates medical device registration through MOHAP typically takes 2-3 months for Class A devices. The official MOHAP target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.United Arab Emirates uses a 4-class (A, B, C, D) - GHTF aligned risk-based classification system. Foreign manufacturers must appoint a UAE Authorized Representative to register devices in United Arab Emirates. Registration is valid for 5 years.

Registration Timeline by Device Class

United Arab Emirates uses a 4-class (A, B, C, D) - GHTF aligned risk-based classification system.

Class A

Registration

Low Risk

Official

1-2 months

Realistic

2-3 months

With Prior Approval

1-2 months

Accelerated with: FDA, EU CE Mark, Health Canada, Australia TGA

• GHTF approvals expedite process

Class B

Registration

Medium Risk

Official

2-4 months

Realistic

3-6 months

With Prior Approval

2-3 months

Accelerated with: FDA 510(k), EU CE Mark, Health Canada

• GHTF recognition pathway available

GMP/QMS Required

Class C

Registration

High Risk

Official

3-6 months

Realistic

4-8 months

With Prior Approval

3-5 months

Accelerated with: FDA 510(k), EU CE Mark, Health Canada, Australia TGA

• Clinical data may be required

GMP/QMS Required

Class D

Full Registration

Highest Risk

Official

4-8 months

Realistic

6-12 months

With Prior Approval

4-7 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical evidence required

Clinical Trial RequiredGMP/QMS Required

Expedited Pathways

GHTF Recognition

Expedited review for devices approved by GHTF founding members

30-50% faster

Eligibility: FDA, EU, Health Canada, Australia TGA, or Japan PMDA approval

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your United Arab Emirates registration.

FDA 510(k)

GHTF recognition - expedited review

2-4 months

EU CE Mark

GHTF recognition

2-4 months

Health Canada

GHTF recognition

2-4 months

Australia TGA

GHTF recognition

2-4 months

Key Requirements

UAE Authorized Representative
Arabic/English labeling
ISO 13485 certification
Free Sale Certificate
GCC conformity assessment

Registration Validity:

5 years

Registration Process Flowchart

United Arab Emirates Medical Device Registration Process

Step-by-step MOHAP registration process. Total estimated timeline: 2-3 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MOHAP. Appoint a UAE Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MOHAP including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MOHAP reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 months

In-depth technical assessment of device safety and performance. MOHAP may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MOHAP issues United Arab Emirates market authorization certificate.

Summary: The United Arab Emirates medical device registration process through Ministry of Health and Prevention (MOHAP) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

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🇺🇸 United StatesFDA 🇪🇺 European UnionEU MDR 🇨🇳 ChinaNMPA 🇯🇵 JapanPMDA 🇧🇷 BrazilANVISA 🇨🇦 CanadaHealth Canada

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.