Navigating the UAE medical device registration process is essential for manufacturers seeking access to the dynamic healthcare market of the United Arab Emirates. This guide outlines the steps and highlights the role of medical device regulatory consultants in the UAE to ensure compliance with UAE medical device regulations.
The UAE Ministry of Health and Prevention (MOHAP) regulates healthcare facilities, licenses professionals, and approves medications and medical devices. The UAE Ministry of Health and Prevention (MOHAP) ensures public health through vaccination campaigns, disease prevention, and health awareness programs.
The UAE Ministry of Health and Prevention (MOHAP) provides medical services through hospitals and clinics, supports health insurance policies, and promotes healthcare research and innovation. Additionally, the UAE Ministry of Health and Prevention (MOHAP) collaborates internationally to maintain global health standards and ensure high-quality, accessible healthcare for residents.
UAE Medical Device Registration Process
Step 1: Determine Device Classification
Start by identifying the classification of your device based on the associated risk level. Devices are grouped into four classes:
- Class I: Low-risk devices
- Class II: Moderate-risk devices
- Class III: High-risk devices
- Class IV: Very high-risk devices
Accurate classification ensures adherence to the UAE medical device regulations and determines the required documentation and registration pathway.
Step 2: Appoint an Authorized Representative
For foreign manufacturers without a legal entity in the United Arab Emirates, it is mandatory to appoint an Authorized Representative for medical devices in UAE. The authorized representative acts as your liaison with the Ministry of Health and Prevention (MOHAP) and oversees compliance with the UAE medical device approval process.
Step 3: Prepare Necessary Documentation
Organize essential documents for the MOHAP medical device registration:
- Proof of Quality Management System (QMS) compliance (e.g., ISO 13485 or GMP certificates)
- Reference country approvals
- Instructions for Use (IFU)
- Labelling and marketing materials
- Manufacturing license
- Free Sale Certificates (FSC)
Proper documentation is crucial to meeting the medical device registration requirements in the UAE.
Step 4: Register the Manufacturer
The manufacturer registration process involves two main steps:
- Market Authorization Holder (MAH) Registration: Submit company details, including name, address, manufacturing license, and GMP/ISO certificates.
- Site Registration: Register the manufacturing site using similar details once MAH registration is complete.
These steps establish the foundation for medical device compliance in the UAE.
Step 5: Register the Medical Device
After manufacturer registration is approved, proceed to Registration of a Medical Equipment service by the Ministry of Health and Prevention (MOHAP) . Submit detailed product information and supporting documents to MOHAP. Collaborating with medical device regulatory consultants in the UAE can help streamline this stage of the UAE medical device registration process.
Step 6: MOHAP Fee Payment and Reviews
The Ministry of Health and Prevention will review your application and documents. This phase can take up to 45 working days, depending on the device’s risk classification and the completeness of the submission. Be prepared for additional requests or corrections from MOHAP to finalize the UAE medical device approval process.
Step 7: Obtain Approval
A registration certificate will be issued upon successful review, which you can download from the MOHAP portal. This certificate confirms compliance with UAE medical device regulations and allows your product to enter the UAE market.
Streamline the Process with Regulatory Experts
Collaborating with medical device regulatory consultants in the UAE can significantly reduce the complexities of the UAE medical device registration process. These experts:
- Assist in organising the necessary documentation
- Navigate the MOHAP submission system
- Ensure compliance with medical device registration requirements in UAE
- Act as your reliable Authorized Representative for medical devices in UAE
Conclusion
The UAE medical device registration process is comprehensive but manageable with the proper support. By following these steps and partnering with experienced medical device regulatory consultants in the UAE, manufacturers can achieve seamless market entry while ensuring full compliance with UAE medical device regulations.
Whether you are a first-time applicant or seeking to expand your portfolio, a thorough understanding of medical device compliance in the UAE is your key to success in the United Arab Emirates.
Frequently Asked Questions: Guide to UAE Medical Device Registration Process
1. What is the process for medical device registration in the UAE?
The registration process involves submitting an application to the UAE Ministry of Health (MOHAP). This includes providing device details, regulatory approvals from other markets, and compliance documentation such as CE marking or FDA approval.
2. What documents are required for registering a medical device in the UAE?
Key documents include a Certificate of Free Sale (CFS), a Declaration of Conformity, ISO 13485 certification, device labeling and packaging details, and an Authorized Representative appointment letter.
3. How long does the UAE medical device registration process take?
The timeline typically ranges from 3 to 6 months, depending on the complexity of the device and the completeness of the submitted documentation.
4. Do foreign manufacturers need a local representative for registration in the UAE?
Yes, foreign manufacturers must appoint a UAE-based Authorized Representative to handle the registration process and ensure compliance with MOHAP regulations.
5. Are there specific requirements for labeling medical devices in the UAE?
Yes, labels must be in Arabic or bilingual (Arabic and English) and include product name, manufacturer details, usage instructions, and warnings. The labels must comply with UAE regulatory standards.
