Before any medical device or pharmaceutical product can be registered and distributed in the United Arab Emirates (UAE), the manufacturer’s site itself must be approved and registered with the UAE Ministry of Health and Prevention (MOHAP).
This step is a prerequisite to product registration and is designed to ensure that all imported healthcare products originate from licensed, compliant, and internationally recognized manufacturing facilities.
Why Manufacturer Site Registration is Required
MOHAP requires every manufacturer supplying the UAE to have its production site registered and approved. This ensures that:
- The site operates under Good Manufacturing Practices (GMP) and meets international quality standards.
- The facility has valid certifications such as ISO 13485 and GMP compliance certificates.
- Products imported into the UAE come only from safe, controlled, and validated environments.
Without site registration, product registration applications cannot proceed.
Documents Required for Manufacturer Site Registration
The documentation depends on whether the facility produces medical devices or pharmaceutical products, but generally includes:
For Medical Devices
- Valid ISO 13485 certificate issued by a recognized certification body.
- Free Sale Certificate (FSC) or equivalent proof that the manufacturer legally sells products in its home market.
- Manufacturer license issued by the local health authority in the country of origin.
- Company profile and manufacturing process description.
For Pharmaceuticals
- Good Manufacturing Practice (GMP) certificate, legalized and issued by the national authority of the country of origin.
- Certificate of Pharmaceutical Product (CPP).
- Valid manufacturing license of the facility.
- Site Master File (SMF) describing the facility layout, operations, and quality systems.
All documents usually require legalization and attestation from the UAE Embassy in the country of origin and the Ministry of Foreign Affairs (MOFA) in the UAE.
The MOHAP Manufacturer Site Registration Process
- Appointment of a Local Agent
Only a MOHAP-licensed local company can submit applications on behalf of foreign manufacturers.
- Submission via MOHAP Portal
The local agent creates an account on the MOHAP e-Services system and submits the site registration application.
- Upload of Documents
All required documents, certificates, and legalized files are uploaded for review.
- MOHAP Evaluation
The MOHAP technical team verifies compliance with GMP/ISO standards and international best practices.
- Approval & Certificate
Once approved, the manufacturer site receives a MOHAP Manufacturer Site Registration Certificate, valid for five (5) years. This certificate is a mandatory requirement for all subsequent product registrations associated with that facility.
Typical Timelines
- Medical device sites: approx. 3–4 months, depending on document completeness.
- Pharmaceutical manufacturing sites: approx. 3–6 months, due to stricter requirements and dossier review.
Trusted Support from ZEVANEX
At ZEVANEX Drug Store L.L.C, we support international manufacturers by managing the entire site registration process with MOHAP Our services include:
- Preparing and reviewing all required documents.
- Ensuring proper legalization and attestation of certificates.
- Handling MOHAP portal submissions and fee payments.
- Responding promptly to MOHAP queries.
- Coordinating site registration alongside product registration for smooth and efficient market entry.
The Path Forward
The registration of manufacturing sites with MOHAP is a critical first step before medical devices or pharmaceuticals can be legally introduced into the UAE healthcare market.
With ZEVANEX as your trusted local partner, manufacturers benefit from a seamless, compliant, and efficient process — ensuring smooth product registration, import permits, and successful distribution across the UAE.