Medical Device Registration UAE: Your 2025 Guide to MOHAP Approval

The United Arab Emirates has firmly established itself as a global hub for innovation, and its healthcare sector is no exception. Fueled by a strategic vision for a world-class health system, significant government investment, and a growing population with sophisticated healthcare needs, the UAE presents a lucrative market for advanced medical technology. For international manufacturers, this translates into immense opportunity. However, accessing this thriving market is contingent upon navigating a rigorous and well-defined regulatory framework managed by the nation’s central health authority.

At the heart of this framework is the Ministry of Health and Prevention (MOHAP), the gatekeeper ensuring that all medical products meet the highest standards of safety, quality, and efficacy. For any company aiming to sell medical devices in the UAE, securing MOHAP approval is not just a procedural step—it is the mandatory license to operate. This comprehensive guide provides a clear, step-by-step roadmap for achieving Medical Device Registration UAE in 2025, empowering you to confidently enter and succeed in this dynamic market.

Understanding the UAE’s Regulatory Landscape

Before embarking on the registration journey, it’s crucial to understand the regulatory environment. The Ministry of Health and Prevention (MOHAP) is the federal body responsible for supervising the healthcare sector across the UAE. Its primary mandate is to protect public health by ensuring that all medical devices, pharmaceuticals, and healthcare services available in the country are safe and effective.

Compliance with MOHAP regulations is non-negotiable. It serves several critical functions:

• Patient Safety: It guarantees that devices used on patients have been thoroughly vetted.
• Market Access: A MOHAP registration certificate is the legal prerequisite for importing, marketing, and selling your device in the UAE.
• Brand Credibility: MOHAP approval signals to healthcare providers and patients that your product meets stringent international and local standards, building trust and a strong market reputation.

The legal framework governing medical devices in the UAE is robust and aligns with global best practices. A pivotal aspect of this framework is the requirement that a foreign manufacturer cannot directly apply for device registration. The law mandates that the application must be submitted by a locally licensed entity acting as the official in-country representative. This leads to the first and most critical prerequisite for any international company: appointing a Local Authorized Representative.

The Prerequisite: Appointing a Local Authorized Representative

The concept of a Local Authorized Representative (LAR) is central to the UAE’s regulatory system. This entity is your legal presence on the ground, acting as the official liaison between your company and MOHAP. The LAR is not merely a logistical partner; they bear significant regulatory responsibilities.

Roles and Responsibilities of the LAR:

• Application Submission: The LAR submits the medical device registration application on your behalf.
• Official Correspondent: All communication from MOHAP, including queries, requests for information, and final approvals, will be directed to the LAR.
• Post-Market Surveillance: The LAR is responsible for monitoring the device’s performance after it enters the market and must report any adverse events or incidents to MOHAP.
• Recall Management: In the event of a product recall, the LAR is legally obligated to coordinate and execute the recall process within the UAE.
• Importation and Distribution: The LAR holds the necessary licenses to import and distribute the registered medical devices.

To act as an LAR, a company must be legally incorporated in the UAE and hold a specific trade license with an activity for “Import of Medical Devices and Equipment.” This license is issued by a competent authority such as the Dubai Department of Economy and Tourism (DET) or a similar body in another emirate.

The appointment of the LAR must be formalized through a legally binding agreement. This is typically a Distribution Agreement or an Authorized Representative Agreement that is:

1. Notarized in the country of origin.
2. Legalized by the UAE Embassy in the country of origin.
3. Attested by the Ministry of Foreign Affairs (MOFA) in the UAE.

This authenticated agreement is a mandatory document in your registration dossier. Choosing a reputable and experienced LAR is arguably the most important decision you will make in this process, as their competence directly impacts the success and speed of your market entry.

Medical Device Classification in the UAE

The foundation of a successful Medical Device Registration UAE application is the correct classification of your product. The UAE follows a risk-based classification system that is harmonized with the internationally recognized Global Harmonization Task Force (GHTF) model, which is also the basis for the European Union’s regulations. This means that if your device is already classified for the EU market, the UAE classification will likely be the same.

The classification determines the regulatory pathway, the depth of required documentation, the application fees, and the level of scrutiny from MOHAP. Devices are categorized into four main classes based on their intended use and the potential risk they pose to patients and users.

Class I: Low Risk

These devices present a minimal potential for harm. They are typically non-invasive and do not come into contact with injured skin.

• Examples: Stethoscopes, non-sterile bandages, tongue depressors, examination gloves, hospital beds.
• **Regulatory

Class IIa: Low to Medium Risk

These devices are generally invasive but are intended for short-term use or are non-invasive devices that interact more significantly with the body.

• Examples: Surgical clamps, hearing aids, dental fillings, contact lens solutions, tracheal tubes.
• **Regulatory

Class IIb: Medium to High Risk

This category includes devices that are often implantable for short-term use or are invasive devices with a higher potential risk if they fail.

• Examples: Infusion pumps, ventilators, blood bags, long-term corrective contact lenses, certain surgical lasers.
• **Regulatory

Class III: High Risk

These are the most critical devices, typically those that are implantable, support or sustain life, or present a high potential risk of illness or injury if they fail.

• Examples: Pacemakers, implantable defibrillators, heart valves, coronary stents, artificial hip joints.
• **Regulatory Correctly identifying your device’s class from the outset is paramount. Misclassification can lead to application rejection, significant delays, and wasted resources.

The Step-by-Step MOHAP Registration Process

With a qualified LAR appointed and your device correctly classified, you can proceed with the formal registration process. The entire system is managed digitally through MOHAP’s online portal, making it efficient but also demanding meticulous preparation.

Step 1: LAR Company Registration with MOHAP

Before your LAR can register any of your products, their own company must be licensed and registered with MOHAP. This involves ensuring they have a valid trade license from the relevant economic department and a medical warehouse license issued by MOHAP. This foundational step confirms the LAR is authorized to handle and store medical products in the UAE. For businesses looking to establish their own LAR entity, partnering with experts in company formation in Dubai Mainland is the most effective starting point.

Step 2: Accessing the MOHAP E-Services Portal

All applications for medical device registration are processed through the MOHAP Smart Services portal. Your LAR will need to have an active account on this platform. They will then create a profile for your manufacturing company under their account. This links your company to the LAR, allowing them to manage applications on your behalf.

Step 3: Document Compilation & The Technical File

This is the most intensive phase of the process. You will work with your LAR to compile a comprehensive technical dossier for each device you intend to register. While specific requirements vary by class, the dossier is generally based on the Common Technical Document (CTD) format. Key components include:

• Administrative Documents: The legalized LAR agreement, company licenses, and application forms.
• **Device Information