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 [...]

For medical devices released by the manufacturer in a sterile form, one of the main principles that assure quality, safety and efficiency is the use of a package that provides maintaining of the medical device characteristics in the process of transportation and storage within [...]

In this article, we’ll try to consider various aspects of validation of software for medical devices. Nowadays, more and more medical devices that are being entered into the market includes software or are represented by a program product without hardware components. These medical devices, [...]

What is nomenclature classification of medical devices by types and what is needed for Each medical device registered on the territory of the Russian Federation should belong to a specified type according to nomenclature classification of medical devices. In fact, the nomenclature type of the [...]