Continuation of registration according to national regulations

To a request to the Eurasian Economic Commission for registration of a medical device in the manner prescribed by the legislation of the Russian Federation, provided that an application for examination or registration of this medical device was submitted before December 31, 2021, the following response was received:

The draft Protocol on 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 dated December 23, 2014 (hereinafter referred to as the Protocol) was approved by the Order of the Commission Council dated April 5, 2021 No. 3 The draft Protocol provides, if an application for the examination or registration of a medical device is submitted in the manner prescribed by the legislation of a member state of the Eurasian Economic Union (hereinafter referred to as the Union), before December 31, 2021, the registration of a medical device may be carried out in accordance with the specified procedure after December 31, 2021 of the year.

It should be noted that at present, the member states of the Union are carrying out internal state procedures necessary for the signing of the Protocol.