As of January 1, 2024, a report from an authorized organization on the compliance of the quality management system (QMS) based on the results of a production site inspection became an obligatory document when applying for: registration of medical devices with risk class 2a [...]

Many manufacturers and distributors are wondering whether their device, apparatus, or equipment is a medical device in Russia. This is a fairly common but tricky question. To answer this, let us start by analyzing what the Russian legislator implies by this concept. According to [...]

Registration of medical devices is a complex, long, and expensive procedure. One way to reduce registration costs is to include several medical devices in one registration certificate. The current national (Russian) registration rules allow for this option, and participants of the national (Russian) medical [...]