Middle East & Africa

United Arab Emirates (UAE)

In the realm of medical device registration within the UAE, it’s imperative to kickstart the process with a crucial initial step: device classification. This essential procedure entails determining the regulatory category of your device, guided by its intended use, risk assessment, and distinctive features. Accurate classification serves as the cornerstone for aligning your device with UAE regulations and plays a pivotal role in shaping your overall registration strategy.

Following proper classification, a knowledgeable team will assist you throughout the registration journey, helping compile essential documentation, liaising with local authorities, and ensuring full compliance with UAE standards. This journey encompasses comprehensive testing, thorough evaluation, culminating in the coveted registration certificate. With specialized expertise, we navigate the intricacies of UAE device classification and registration, paving a clear path for market entry and success in this dynamic region.

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Saudi Arabia

If you’re considering selling a medical device in Saudi Arabia, it’s important to understand the steps involved. The Saudi Food and Drug Authority (SFDA) has specific rules to ensure that medical devices are safe and effective for use. The process includes a thorough examination by the SFDA, which involves testing your device, reviewing documentation, and making sure it meets all the necessary standards.

Navigating this process can be complex, but you don’t have to do it alone. Our team of experts specializes in guiding businesses through every step of the registration process. We’ll help you classify your device correctly, gather the required documents, and ensure your device complies with Saudi Arabian regulations. By working with us, you can have confidence in bringing your medical device to the Saudi Arabian market, where it can contribute to improving healthcare services in the country. We’re here to make the journey smoother and help you meet all the necessary requirements for successful registration.

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Israel

Registering your medical device in Israel is a pivotal step for those looking to enter this thriving market. The Israeli Ministry of Health meticulously assesses each device to guarantee its safety and effectiveness, involving thorough testing, meticulous documentation review, and adherence to precise regulatory standards. While navigating these requirements can be intricate, our team of experts is here to assist you through every phase of the registration process.

From initial classification to submission and compliance, we ensure your medical device satisfies all necessary criteria. With our assistance, you can confidently introduce your medical device to the Israeli market, contributing to healthcare advancements and positively impacting patients’ lives.

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