Registration of Medical Devices within the Eurasian Economic Union

All medical devices must be registered. This requirement applies not only to those used in Russia, but also to those used in the territory of the EAEU. The registration procedure for medical devices has a number of features and is regulated by decisions of a special Council.

A medical device can be registered in accordance with the rules of domestic legislation or the EAEU rules. The applicant has the right to independently select the type of medical device registration until December 31, 2021. From this date onwards, all medical devices will be registered in accordance with the uniform rules of the EAEU. It is important to note that medical devices registered within the EAEU are permitted for free circulation in the territories of Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.

Medical devices intended for circulation in the territory of the EAEU must be registered in accordance with the procedures set out in Decision No. 46 dated December 12, 2016 and No. 109 dated December 23, 2014. Clause 11 of Article 4 of Decision No. 109 dated December 23, 2014 (which came into force on January 1, 2015) clearly sets out the cases when registration of medical devices is not required.

The applicant for the procedure may be either the manufacturer or its authorized representative. They must be residents of a country that is part of the EAEU. Legalization may be carried out in one or several states of the Union. A certificate is issued to confirm the completion of the registration procedure. It is issued indefinitely and extends its validity to the entire territory of the EAEU.

The procedure for registering a medical device has a number of features and is divided into two stages:

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