Features of submission of documents within the framework of registration procedures for medical devices from January 1, 2022

The Federal Service for Surveillance in Healthcare informs that in accordance with the legislation in force on the territory of the Russian Federation in the field of circulation of medical devices (Protocol of December 30, 2021 on Amending the Agreement on Uniform Principles and Rules for the Circulation of Medical Products (Medical Products and Medical Equipment) ) within the framework of the Eurasian Economic Union dated December 23, 2014 and the Resolution of the Government of the Russian Federation dated December 10, 2021 No. 2250 „On Amending the Resolution of the Government of the Russian Federation No. 430 dated April 3, 2020“):

– applications for the purpose of going through the procedure for state registration of medical devices, including medical devices included in the list, from January 1, 2022, will not be accepted by Roszdravnadzor;

– the procedure for state registration of medical devices, including medical devices included in the list, applications for state registration of which were submitted to Roszdravnadzor before December 31, 2021, will be continued as planned (with the possibility of submitting relevant materials and information to Roszdravnadzor);

– acceptance of applications in order to go through the procedure for amending the documents contained in the registration dossier is carried out by Roszdravnadzor in a regular mode;

– acceptance of applications for the purpose of passing the procedure for state registration of a series (batch) of a medical device (in accordance with the Peculiarities of the circulation of medical devices, including state registration of a series (batch) of a medical device, approved by the Government of the Russian Federation dated 03.04.2020 No. 430) is carried out in planned order;

– acceptance of applications for the purpose of passing the registration procedure for medical devices in accordance with the law of the Eurasian Economic Union is carried out by Roszdravnadzor in a regular mode.

In addition, we inform you that at the meeting of the Council of the Eurasian Economic Commission, held on December 24, 2021, the issue of making new amendments to the Agreement on uniform principles and rules for the circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union, which relate to the extension the national registration regime for one year – until December 31, 2022. The parties approved the direction of the protocol for domestic procedures and signing. Information on the possibility and timing of resuming the submission of documents in order to initiate the procedure for state registration of medical devices will be announced additionally.