Registration of Medical Devices for IVD

Under current legislation, the registration of in vitro diagnostic (IVD) devices is a single-step process that does not require obtaining a Permit for Clinical Laboratory Testing (CLT). Therefore, our in vitro diagnostic registration specialists focus on the following aspects during the dossier compilation for submission to the Federal Service for Surveillance in Healthcare (Roszdravnadzor):

• Creating and adjusting technical documentation, considering the specific requirements for describing IVD devices and compiling well-informed requests for missing information;
• Selecting suitable laboratories and coordinating the technical (and, if necessary, toxicological) testing of devices, reagents, laboratory equipment, and self-diagnostic products. Established contractual relationships with leading laboratories ensure the timely receipt of high-quality test protocols (including functional characteristics/electrical safety/electromagnetic compatibility);
• Comprehensive support and consultation in planning and organizing clinical laboratory testing, including obtaining correctly formatted protocols based on CLT outcomes. Throughout the project, each device is matched with an appropriate medical institution and a registered Russian analog, and if necessary, reference to a “gold standard” and developing a clear plan for the entire CLT period. We collaborate with major medical institutions and have established contractual relationships with leading clinical diagnostic laboratories in Moscow and the Moscow region, positively impacting the duration of such labor-intensive tests.

Throughout the registration process, the company’s project manager will provide full support and expert advice on any arising issues, guiding you through to the receipt of the Registration Certificate.