MOHAP Medical Device Registration in UAE is a mandatory requirement for any business planning to manufacture, import, distribute, or market medical devices within the country. Regulated by the Ministry of Health and Prevention (MoHAP), this process ensures that medical devices comply with strict safety, quality, and performance standards.
Unicorn Global Solutions L.L.C provides end-to-end support for Medical device registration in Dubai and across the Emirates, helping businesses navigate compliance smoothly and enter the UAE healthcare market without delays.
This guide explains the registration of medical devices in UAE, highlights key United Arab Emirates medical device regulations, and shows how expert assistance can simplify approvals and accelerate market entry.
Introduction
Medical Device Registration in the UAE is a structured regulatory process that requires strict adherence to MoHAP guidelines, reference country approvals, and accurate technical documentation. When managed professionally, registration can typically be completed within 6–8 weeks, with government fees ranging from AED 5,000 to AED 15,000, depending on device risk classification.
By following the official medical device registration guideline UAE, businesses can reduce compliance risks, avoid rejections, and launch products confidently in a fast-growing healthcare market.
Understanding Medical Device Licensing in the UAE
Medical device licensing is the foundation of lawful market entry in the UAE. It applies to:
- Manufacturers
- Importers
- Distributors
- Authorised Representatives
Without MoHAP approval, medical devices cannot be imported, sold, or promoted in the UAE, including Dubai, Abu Dhabi, and other Emirates.
Unicorn Global Solutions L.L.C assists clients throughout the entire Medical Device Registration in the UAE process, ensuring alignment with current regulatory expectations.
Why Medical Device Registration Matters in the UAE
Medical Device Registration in the UAE is not just a legal requirement—it establishes credibility and trust.
Key benefits include:
- Legal authorisation to sell and distribute devices
- Compliance with UAE medical device regulations
- Acceptance by hospitals, clinics, and pharmacies
- Eligibility for tenders and insurance-linked procurement
- Stronger partnerships with distributors
For companies targeting medical device registration in Dubai, MoHAP approval is often the first requirement requested by healthcare stakeholders.
United Arab Emirates Medical Device Regulations – Regulatory Overview
The registration of medical devices in UAE is governed by MoHAP and aligned with international regulatory systems. The UAE recognises approvals from reference authorities such as:
- European Union (CE Marking)
- United States (FDA)
- United Kingdom (MHRA)
- Canada (Health Canada)
- Australia (TGA)
Although reference approvals streamline evaluation, devices must still comply with local labelling, vigilance, and post-market obligations under United Arab Emirates medical device regulations.
Core Pillars of Medical Device Registration in the UAE
MoHAP Compliance Requirements
- Safety and performance evidence
- Risk classification
- Quality management systems (ISO 13485)
- Electrical and clinical safety standards (where applicable)
Strict compliance is essential for successful Medical Device Registration in the UAE.
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Medical Device Classification in the UAE
Accurate classification is a critical step under the medical device registration guideline UAE:
- Class I – Low risk
- Class II – Medium risk
- Class III – High risk
Classification determines:
- Documentation depth
- Review timeline
- Registration fees
Step-by-Step Medical Device Registration Process in the UAE
The standard Medical Device Registration in the UAE process includes:
1. Establishment Registration
Registering the local company or Authorised Representative with MoHAP.
2. Device Registration Application
Submission of device details through the MoHAP online system.
3. Technical Documentation Submission
Including certificates, labelling, conformity assessment, and technical files.
4. Review and Authority Queries
MoHAP evaluates the application and may request clarifications.
5. Certificate Issuance
Upon approval, the device is legally authorised for sale in the UAE.
This process applies equally to medical device registration in Dubai and other Emirates.
Cost and Timeline for Medical Device Registration in the UAE
- Government fees: AED 5,000 – AED 15,000 per device
- Approval timeline: Typically 6–8 weeks
- Validity: Registration is generally valid for 5 years
Additional costs may apply depending on device complexity and UAE medical device regulations
Building Trust and Market Presence Through Registration
Medical Device Registration in the UAE demonstrates that a product meets rigorous regulatory standards. This builds trust with:
- Healthcare institutions
- Medical professionals
- Procurement teams
- Patients and insurers
Registered devices achieve faster acceptance and stronger positioning in the UAE healthcare sector.
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Long-Term Benefits of Medical Device Registration
Beyond initial approval, the registration of medical devices in UAE offers:
- Easier expansion into GCC markets
- Access to public and private tenders
- Stronger distributor confidence
- Improved brand reputation
- Sustainable regulatory compliance
How Unicorn Global Solutions L.L.C Supports Medical Device Registration
Unicorn Global Solutions L.L.C offers comprehensive support for Dubai Medical Device Registration , helping businesses comply with UAE medical device regulations efficiently.
Our services include:
- Regulatory assessment and device classification
- MoHAP establishment and device registration
- Documentation preparation and review
- Authority coordination and query handling
- Post-market compliance guidance
With regulatory expertise and structured compliance support, we help clients achieve faster approvals and stress-free Medical Device Registration in Dubai and across the UAE.
Need Help?
Medical Device Registration in the UAE is a critical step toward entering one of the region’s most advanced healthcare markets. By complying with United Arab Emirates medical device regulations and following the official medical device registration guideline UAE, businesses can achieve faster approvals, build credibility, and ensure long-term compliance.
Unicorn Global Solutions L.L.C simplifies the registration of medical devices in UAE through expert guidance and structured regulatory support. Contact us today to move forward with confidence and unlock seamless market entry. Text us on whatsApp or call us today .
Frequently Asked Questions (FAQs)
A locally registered entity responsible for registration, importation, and post-market compliance.
In most cases, yes, as per United Arab Emirates medical device regulations.
No. Marketing or importation is prohibited before MoHAP approval.
Ongoing surveillance, adverse event reporting, and corrective actions.
NOTE:
The above note is subject to further study and clarification. It does not constitute a formal opinion from our end. Before making any decisions based on the above, we recommend consulting our experts on the subject.
