English
The company has extensive experience in registering medical devices for in vitro diagnostics (including self-testing) and takes into account all the peculiarities of the registration process for this class of medical devices in its work.
According to current legislation, the registration of in vitro diagnostic devices (IVD) is a one-step process without obtaining permission for clinical laboratory trials (CLT). Therefore, specialists in IVD registration at the dossier collection stage for submission to the Federal Service for Surveillance in Healthcare pay attention to the following points:
- Creation and correction of technical documentation, taking into account the specific requirements for describing IVD devices, and drafting competent requests for missing information.
- Selection of suitable laboratories and coordination of technical (and, if necessary, toxicological) testing of devices, reagents, laboratory equipment, and self-diagnostic products. Established contractual relationships with leading laboratories guarantee the receipt of high-quality test protocols (including functional characteristics/electrical safety/electromagnetic compatibility) within acceptable timeframes.
- Comprehensive support and consulting in planning and organizing clinical laboratory trials, including obtaining properly formatted protocols based on the results of CLT. Each device is matched with a suitable healthcare institution and a registered analogue in the Russian Federation, and if necessary, reference to the "gold standard" and the development of a clear plan for the entire CLT period. The company collaborates with major healthcare institutions and has established contractual relationships with leading clinical diagnostic laboratories in Moscow and the Moscow region, which positively affects the timing of these complex trials.
Throughout the registration process, the project manager of the company will provide full support and offer expert advice on any arising issues until the registration certificate is obtained.