Decoding the Requirements for Classification of a Medical Device Application in UAE

Introduction:

The United Arab Emirates (UAE) is a rapidly evolving hub for medical innovation and healthcare services. For manufacturers aiming to introduce medical devices into this dynamic market, understanding the regulatory landscape is crucial. In this blog post, we will guide you through the classification requirements for medical devices in the UAE, ensuring you have the essential knowledge to navigate this complex process.

Understanding Medical Device Classification:

Medical devices in the UAE are regulated by the Ministry of Health and Prevention (MOHAP). The classification of medical devices is pivotal as it determines the regulatory requirements for market entry. Medical devices are classified based on their intended use and the potential risk to patients and users. The classification system in the UAE aligns closely with international standards, such as those from the International Medical Device Regulators Forum (IMDRF) and the European Union Medical Device Regulation (EUMDR).

Classification of Medical Apps:

Medical apps in the UAE are classified based on their intended use and the risk they pose to users. This classification aligns with international standards such as IMDRF and the EUMDR.

1.  Non-Medical Apps: Apps that are intended for general wellness, fitness tracking or other non-medical purposes do not require registration with MOHAP.
2. Medical Apps: The apps that are intended for diagnosis, treatment, monitoring or prevention of diseases must be registered with MOHAP. They are further classified into different risk categories (Class I, IIa, IIb, III) based on their functionality and potential impact on patient safety.

Steps for Registering a Medical Application:

The first step is to determine whether your app qualifies as a medical device and if so, its classification. This involves assessing the app’s intended use and functionality. Consulting with regulatory from MOHAP can help ensure accurate classification. The second step is to appoint a Local Authorized Representative (LAR). For international developers, appointing UAE-based LAR is mandatory.

MOHAP Requirements for Classification:

1. Certificate from Country-of-Origin Regulatory Authority related to the submitted Product. Copy of CPP/ Free Sale Certificate/CFG, CE, ISO (along with English or Arabic Translation).
2. Product size list / Accessories list (if Applicable).
3. Product Picture.
4. Product Information/ Information for user/ Leaflet/ User guide/ Manual in English/ Arabic.
5. Product Catalogue / Brochure.
6. Inner and Outer pack label with clear and readable product name and information.
7. Composition certificate.
8. Registration and Marketing Status.

Documents upon request by MOH:

1. Product sample in their Final Original Pack.
2. MOHAP Quality Control Lab Analysis Report.
3. Letter of Authorization from Marketing Authorization Holder.

Conclusion:

The classification of medical applications in the UAE is a critical process that ensures the safety and efficacy of these tools in improving healthcare outcomes. By understanding the regulatory framework, classification criteria, and compliance steps, developers and manufacturers can navigate the approval process more effectively and contribute to the advancement of healthcare in the region. As technology continues to evolve, staying informed and proactive in meeting regulatory requirements will be key to success in the burgeoning field of medical application.