MOH Registration of Products
Get your medical products approved for the UAE market. We manage the full MOHAP registration process to approval.
Overview
To legally import, distribute, and sell medical products in the UAE, they must be registered with the Ministry of Health and Prevention (MOHAP). Registration requires a comprehensive technical dossier, evidence of international approvals, an authorised local agent or distributor, and full compliance with UAE regulatory requirements, a demanding process where small errors cause long delays.
Bacora manages MOHAP product registration end-to-end. We compile and review the technical dossier, ensure your supporting approvals and certificates meet UAE requirements, submit the application, and liaise with MOHAP throughout, so your products reach the market as efficiently as the regulatory process allows.
What Bacora Handles
- Compile and review the full technical dossier for the product
- Verify international approvals, certificates, and conformity evidence
- Advise on the authorised local agent or distributor requirement
- Prepare and submit the MOHAP registration application
- Manage all MOHAP correspondence, queries, and additional requests
- Follow up to approval and advise on renewals and variations
How We Work, Step by Step
A clear, structured process from first contact to final delivery.
Dossier Preparation
We compile and review the technical dossier and confirm every required document is in order.
Compliance Check
We verify approvals and certificates against UAE requirements before anything is submitted.
Submission
We submit to MOHAP and manage all correspondence, queries, and additional requests.
Approval
We follow up to registration approval and advise on renewals and future variations.
Frequently Asked Questions
Do I need a local agent to register a product?
In most cases, foreign manufacturers must register through an authorised local agent or distributor holding the appropriate trade licence. We advise on this requirement for your situation and can help structure the arrangement correctly so registration can proceed.
How long does MOHAP product registration take?
Timelines vary by product type, risk class, and the completeness of the dossier, and can range from a few months upward. A complete, correctly prepared file is the single biggest factor in avoiding delays. We give you a realistic estimate for your specific product.
What if my product is already approved elsewhere?
Existing approvals such as CE marking or FDA clearance strengthen your application and are often part of the required evidence, but they do not replace MOHAP registration. The product still needs to be registered in the UAE, and we use your existing approvals to support the file.
Do registrations need to be renewed?
Yes. Product registrations are valid for a defined period and must be renewed to keep the product on the market. We track your renewal dates and manage the renewal process, as well as any variations needed if the product or its documentation changes.
Ready to Get Started?
Book a free consultation. We will review your situation and tell you exactly what you need and how long it will take.
