Useful articles
Inspection of medical device production for registration in Russia
As of January 1, 2024, a report from an authorized organization on the compliance of the quality management system (QMS) based on the [...]
Is my product a medical device in Russia? Criteria for classifying as a medical device
Many manufacturers and distributors are wondering whether their device, apparatus, or equipment is a medical device in Russia. This is a fairly common [...]
What medical devices can be included in one registration certificate in Russia and the EAEU countries?
Registration of medical devices is a complex, long, and expensive procedure. One way to reduce registration costs is to include several medical devices [...]
Validation of the process of medical devices packing in Russia
For medical devices released by the manufacturer in a sterile form, one of the main principles that assure quality, safety and efficiency is [...]
Validation of software for medical devices
In this article, we’ll try to consider various aspects of validation of software for medical devices. Nowadays, more and more medical devices that [...]
Nomenclature classification of medical devices by types in Russia
What is nomenclature classification of medical devices by types and what is needed for Each medical device registered on the territory of the Russian [...]