Are you looking to enter the Middle East market with your medical devices? At Registitute, we provide specialized, end-to-end support for medical device registration in Egypt and across the wider MENA Region, particularly in Saudi Arabia, ensuring full compliance with local regulatory frameworks and a seamless path to market.

As a trusted regulatory and market access partner, we assist medical device manufacturers, in vitro diagnostic (IVD) companies, pharmaceutical firms, and biotechnology innovators with customized solutions throughout the MENA region. Our in-depth expertise in medical device registration in Egypt enables us to help you navigate complex procedures set by the Egyptian Drug Authority (EDA) and other local entities, reducing delays and avoiding common pitfalls.

Our services include comprehensive regulatory consulting, technical file preparation, documentation review, application submission, and continuous follow-up until final approval is secured. We also provide local representation for foreign manufacturers, clinical trial support, and cutting-edge digital tools that streamline the entire registration process.

Whether you are a global manufacturer expanding into the MENA Region—especially Egypt and Saudi Arabia—or a regional stakeholder launching new devices, Registitute is your strategic partner. Our team of regulatory experts ensures that every step, from classification and documentation to final approval, is handled with precision and in line with the latest guidelines from the EDA and other regional authorities.