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Medical Device & Pharmaceutical Product Registration (MOHAP)

Medical Devices & Pharmaceutical Product Registration Services (UAE MOHAP Compliance)

At Montgo Health Systems, we provide end-to-end regulatory support for medical devices, pharmaceuticals, and cosmetic product registrations in the UAE. Our experts ensure your products meet MOHAP requirements, are correctly classified, and successfully approved for market entry without delays or compliance risks.

Start Your Product Registration Journey

Our Clients

Our exceptional team lead’s expertise sets us apart in healthcare consultancy. Benefit from their profound knowledge, ensuring your success in this dynamic industry. Choose Montgo Health Systems for unparalleled guidance.

Medical Device Classification (Class I to Class IV)

We assist in the correct classification and registration of medical devices based on MOHAP regulatory standards, ensuring each product is accurately assessed from low-risk (Class I) to high-risk (Class IV) devices for smooth approval and market clearance in the UAE.

Why Choose Us?

How We Are Best in Medical Devices & Pharmaceutical Registration!

Montgo Health Systems brings a unique blend of healthcare regulatory mastery, product-registration experience and UAE market insight. Our comprehensive approach ensures your registration process is smooth, compliant and strategically sound.

Regulatory Classification & Strategy

We help determine device class or pharmaceutical category, advise on UAE requirements and map the registration pathway.

Comprehensive Dossier Preparation

From technical specifications and clinical data to labeling, GMP certificates and safety reports—we compile and review every document.

Local Agent & Authority Liaison

We act as your UAE-based authorised representative, handling submissions to Ministry of Health and Prevention (MOHAP) and liaising with committees for faster clearance.

Submission & Tracking Support

We manage all filings, track application status, respond to queries and ensure timely approval.

Post-Market Compliance & Renewals

Global Reference & Local Market Access

Global Reference & Local Market Access

Whether you hold FDA/CE approval or are launching in the UAE first, we adapt your strategy for regional market access and establish local import/distribution readiness.

Pharmaceutical & Cosmetic Registration (MOHAP)

We manage the complete registration process for pharmaceutical and cosmetic products under MOHAP guidelines, including documentation, safety compliance, and submission requirements to ensure successful approval and legal market authorization in the UAE.

Medical Device & Product Registration Process (MOHAP UAE Compliance)

At Montgo Health Systems, we manage the complete regulatory pathway for medical devices, pharmaceuticals, and cosmetic products in the UAE. From technical documentation to authority submissions, we ensure full MOHAP compliance, reducing delays, rejections, and regulatory risks.

Regulatory Classification & Product Assessment

We evaluate your product to determine correct MOHAP classification and regulatory pathway, ensuring it meets UAE compliance standards before submission.

Technical Dossier Preparation & Submission

We prepare and submit a complete regulatory dossier, including product specifications, safety data, and technical documentation required by MOHAP.

Label Compliance Review

We check and align all product labels with UAE regulatory requirements, ensuring accurate ingredients, claims, and mandatory Arabic/English labeling compliance.

Local Distributor & Importer Matching

We connect you with licensed UAE distributors and importers, which is a mandatory requirement for product registration and market entry approval.

MOHAP Review, Approval & Market Authorization

We coordinate with authorities throughout the review process, handle queries, and secure final MOHAP approval for legal distribution and sales in the UAE.

Your healthcare journey starts with Montgo Health Systems

Explore our service, learn more about our services and expert team,
and feel free to contact us with any inquiries or to schedule a consultation.
Your healthcare aspirations are within reach with Montgo Health Systems by your side.

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FAQs

Frequently Asked Questions About Device & Pharmaceutical Registration

Find answers to key questions about classification, regulatory processes, timelines, and how Montgo supports your registration journey.
Do medical devices and pharmaceuticals both need registration in the UAE?
Yes. Products like medical devices, pharmaceuticals and in-vitro diagnostics all require registration with MOHAP or other authorised bodies.
Who can act as the local authorised representative?
A UAE-licensed distributor or local entity must be appointed; Montgo can serve or help you appoint the correct local partner.
How long does registration usually take?
While timelines vary by product complexity and class, many approvals can be achieved in 45 working days when all documents are in place.
What documents are typically required?
Technical file, risk assessments, GMP/ISO certificates, free-sale certificates from origin country, labeling in English/Arabic and local agent info.
Is registration valid indefinitely?
No. Once approved, registration certificates are valid for a period (often five years); you’ll need to manage renewals and post-market duties.
Can Montgo assist with global product registration as well?
Yes. Our regulatory team has insight in UAE, GCC and global markets—supporting both local registration and export readiness.
What happens if my product fails to meet UAE requirements?
Montgo conducts remedial gap analysis, advises on necessary modifications, and supports re-submission to meet regulatory standards.
Why register your product rather than import without registration?
Without registration, importation or sale is illegal in UAE healthcare market. Proper registration ensures compliance, market access and buyer trust.

Get in Touch

Tell Us About Your Product Registration Needs!

Share your product details—device class, pharmaceutical composition or intended market—in UAE or regionally. Our regulatory specialists will review your case, design a registration roadmap and manage submission, monitoring and post-approval compliance on your behalf.

Technical file and dossier development

Local authorised representation & submission

Post-market monitoring & renewal support