Registration of medical devices is a complex multi-stage process that requires specific knowledge and, more importantly, relevant experience. That is why when you register a medical device with the help of KC-PROF experts you are guaranteed to receive a registration certificate in the shortest time possible. This result comes from the coordinated work of highly qualified experts with many years of experience in the field of medical device circulation. Our department of medical device registration consists of 9 experts, including 2 candidates of technical and 1 candidate of biological sciences.
What is registration and why is it necessary to register medical devices?
Following paragraph 4 of Article 38 of the Federal Law N 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” dated November 21, 2011, the circulation of medical devices is allowed on the territory of the Russian Federation only if they were registered in the procedure established by the Government of the Russian Federation, by its authorized federal executive body.
Registration of medical devices is a state procedure developed to bring to the market only those products which are effective, safe and have high quality. The registration certificate (RC) is a document which confirms the compliance of medical devices with the established requirements and the fact of their registration in Russia. Therefore, RC is a document mandatory for the circulation of a medical device on the Russian market. In other words, the registration of medical devices is a prerequisite for their import, use, sale, as well as production on the territory of the Russian Federation.
Registration of medical devices on the territory of the Russian Federation is conducted by the Federal Service for Supervision of Healthcare of the Russian Federation (Roszdravnadzor). In the process of state registration, Roszdravnadzor sends the registration dossier of a medical device to one of the subordinate organizations, FSBI VNIIIMT or FSBI NIK (formerly called FSBI CMIKEE), for quality, safety and effectiveness examination.