MOH Registration of Products

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MOHAP Product Registration Services

Entering the UAE’s healthcare sector requires adherence to stringent regulatory standards set by the Ministry of Health and Prevention (MOHAP). Whether you’re introducing pharmaceuticals, medical devices, or health supplements, securing MOHAP product registration is a critical step to ensure legal compliance and market access.

Understanding MOHAP Registration

MOHAP oversees the registration of various healthcare products to ensure they meet the UAE’s safety and quality standards. Products requiring registration include:

At Cosmopole, we specialize in guiding businesses through the complex MOHAP registration process. Our team of experts provides end-to-end support, from initial classification to final approval, ensuring a seamless experience. With our assistance, you can focus on your core operations while we handle the regulatory intricacies.

Required Documents

To initiate the MOHAP registration process, the following documents are typically required:

Valid Trade License and Drugstore License
Authorization letter from the manufacturer
Certificates from the country of origin (e.g., Free Sale Certificate, GMP Certificate)
Product information leaflet in English and Arabic
Composition certificate or Material Safety Data Sheet (MSDS)

Note: Additional documents may be required based on the specific product category.

Our Comprehensive Registration Services

Cosmopole offers a full suite of services to streamline your MOHAP registration process:

Product Classification: Determining the appropriate category for your product to ensure correct registration pathways.
Document Preparation: Assisting in the compilation and review of all necessary documentation.
Application Submission: Managing the online submission through the MOHAP portal.
Liaison with Authorities: Communicating with MOHAP officials to address any queries or additional requirements.
Follow-Up and Approval: Monitoring the application status and facilitating the issuance of the registration certificate.

Partner with Cosmopole to navigate the MOHAP registration process efficiently and effectively. Contact us today to schedule a consultation and take the first step toward entering the UAE healthcare market.

Frequently Asked Questions (FAQs)

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qWhat is MOHAP product registration? What is a lawful permanent resident?

MOHAP product registration is the official process by which healthcare products are evaluated and approved for sale in the UAE. This ensures that all products meet the country's safety and quality standards.
qWhy is MOHAP registration necessary?

Registration is mandatory for legal distribution and sale of healthcare products in the UAE. It also enhances product credibility and consumer trust.
qCan foreign companies register products without a local presence?

No, foreign companies must appoint a local authorized representative in the UAE to handle the registration process and liaise with MOHAP.
qHow long does the registration process take?

The timeline varies depending on the product category and completeness of the application but typically ranges from 45 to 90 working days.
qWhat happens if my product is not approved?

If a product is not approved, MOHAP will provide reasons for the rejection. You can address the issues and reapply. Cosmopole can assist in identifying and rectifying any deficiencies in your application.
qIs the registration certificate permanent?

No, registration certificates are valid for a specific period, usually five years. Renewal applications must be submitted before the expiration date to maintain market authorization.
qDoes Cosmopole assist with renewals and post-registration compliance?

Yes, we offer ongoing support for certificate renewals and ensure that your products remain compliant with any regulatory updates or changes.