Medical device registration in the UAE is governed by the Ministry of Health and Prevention (MOHAP), ensuring compliance with stringent regulatory requirements. Device manufacturers must meet standards for classification, safety, and quality to obtain a certificate of registration.
Step-by-Step Process for Registering Medical Equipment in the UAE
Appoint a Local Authorized Representative (LAR)
Appoint a licensed LAR in the UAE to handle the registration process and communicate with MOHAP on your behalf.
Gather and Submit Required Documents
Collect required documents such as the manufacturing facility certificate, certificate of free sale (CFS), product classification details, technical documentation, quality certificates, and post-market surveillance plan.
Classify the Medical Device
Classify your device into one of four categories (Class I, IIa, IIb, or III) based on its risk level, which will determine the registration process.
Submit the Application
Submit the registration application with all required documents through the MOHAP online portal.
Pay Registration Fees
Pay the applicable registration and classification fees through the MOHAP payment system.
MOHAP Review
MOHAP reviews the application and documents, which may take up to 45 working days. Additional information may be requested.
Start Your Business Journey with Our Professional Support!
Benefits of Medical Device Registration in Dubai, UAE
Requirements for Registering Medical Equipment in the UAE
- Local Authorized Representative (LAR): Foreign manufacturers must appoint a licensed LAR in the UAE to handle registration.
- Manufacturing Facility Certificate: Proof of manufacturing registration from the country of origin.
- Certificate of Free Sale (CFS): Confirms the product is legally sold in its home country and attested by the UAE Embassy.
- Agency Agreement: Contract between the manufacturer and LAR for registration and market entry.
- Product Classification: Devices must be categorized based on risk level (Class I, IIa, IIb, III).
- Technical Documentation: Submit details like design, labels, usage, safety data, and manuals.
- Quality Certificates: Provide EC Declaration of Conformity or ISO 13485:2016.
- Certificate of Analysis (COA): Verify specifications and performance.
- Post-Market Plan: Ensure safety checks after registration, especially for high-risk devices.
- Fee Payment: Pay all fees during the submission process.
- Class I (Low Risk): Simple devices like bandages or thermometers, requiring basic documents.
- Class IIa (Low to Moderate Risk): Devices like dental tools or imaging systems, needing extra safety checks.
- Class IIb (Moderate to High Risk): Surgical tools or implants, requiring detailed data and testing.
- Class III (High Risk): Critical devices like pacemakers or ventilators, needing strict clinical evidence.
Required Documents for Medical Device Registration
| Document Name | Description |
|---|---|
| Local Authorized Representative Agreement | Appointment contract between the manufacturer and the LAR in the UAE. |
| Manufacturing Facility Registration Certificate | Issued by the competent authority in the country of origin. |
| Certificate of Free Sale (CFS) | Certified by the UAE Embassy, confirming the device’s legal sale in the country of origin. |
| Product Classification Information | Classification details based on the device’s risk category (Class I, IIa, IIb, III). |
| Technical Documentation | Product details including design, intended use, labeling, and safety instructions. |
| Quality Certificates | EC Declaration of Conformity, ISO 13485:2016, or other relevant quality certifications. |
| Certificate of Analysis (COA) | Verifying the equipment’s specifications and compliance with performance standards. |
| Post-Market Surveillance Plan | A detailed plan for monitoring the device’s safety and performance post-market. |
| Fees Payment Proof | Evidence of payment for application, registration, and classification fees. |
Medical Device Registration Consultants in Dubai
How Riz & Mona Consultancy Can Help?
Riz & Mona Consultancy is renowned as one of the top business setup consultants in Dubai, with over 15 years of experience facilitating a wide range of businesses throughout the UAE. Our deep connections with government officials and key authorities, combined with our extensive expertise in consultancy, streamline the process of establishing your business in Dubai. Additionally, we offer comprehensive financial, legal, and corporate services to support our clients throughout their business endeavors.
We are here to provide comprehensive support for your Medical Device Registration in Dubai, from preparing your documents to completing the process. Connect with us now to begin your journey with a FREE consultation!
FAQS (Frequently Asked Questions)
What is the difference between DHA and MoHAP?
The Dubai Health Authority (DHA) regulates healthcare in Dubai, while the Ministry of Health and Prevention (MoHAP) oversees the regulation of medical devices and healthcare services nationwide in the UAE.
What is the drug regulatory authority in the UAE?
The Ministry of Health and Prevention (MoHAP) is the primary regulatory authority for drugs and medical devices in the UAE.
What is the medical device law in the UAE?
The medical device law in the UAE is governed by the Federal Law No. 24 of 2006, which sets standards for the registration, import, and distribution of medical devices.
What is the average length of time for the registration of a medical device?
The registration process for a medical device in the UAE typically takes 30 to 45 working days, depending on the device’s classification and completeness of the submitted documents.