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The procedure for national registration of medical devices at the EAEU level has been extended until 2025
On February the 13th, the protocol was published on the EAEU portal on the extension of the registration of medical devices according to national [...]
The Federal Service for Surveillace in Healthcare has developed a list of necessary data on non-original components for medical devices
A draft order of the Federal Service for Surveollance in Healthcare was posted on the legal information web-site. The document contains the requirements to the [...]
423 medical devices have been registered under the accelerated procedure in 2022
According to the Federal Service for Surveillance in Healthcare, last year 423 items of medical devices successfully passed accelerated registration. Of these, 31 products fell [...]
The Government allowed the use of components for servicing that are not listed in the documentation for medical devices
Government Resolution No. 2525 dated the 29th of December, 2022, allows the use of components that are not listed in the technical documentation for [...]
The procedure for inspecting the production of medical devices has been updated
On January 1, 2023, a new procedure for checking the production of medical devices, approved by the Government, came into force. The corresponding order [...]
The service for checking of registered medical devices may become publicly available
Mass media inform about the readiness of the Federal Service for Surveillance in Healthcare to provide market participants with access to information about manufactured medical [...]
The Ministry of Health requires the rapid development of domestic medical equipment
The Head of the Ministry of Health ordered the companies developing medical equipment to speed up the process of import substitution. In the context [...]
Restriction of exportation of medical drugs and medical devices from the Russian Federation is prolonged for a year
The Russian President Vladimir Putin has signed the order according to which exportation of some kinds of goods will be restricted to the 31st [...]
Prolongation of the transition period to the common rules of medical devices registration is on the ECE agenda
The agreement on the unified principles and rules of trade of medical devices in the EAEU countries is subjected to new changes. The ECE [...]