Registration of medical devices within the framework of the Eurasian Economic Union

Regulation of the circulation of medical devices within the framework of the Eurasian Economic Union is carried out in accordance with the Treaty on the Eurasian Economic Union of May 29, 2014, the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the framework of the Eurasian Economic Union of December 23, 2014, other international treaties constituting the law of the Union, decisions of the Commission, as well as the legislation of the Member States.

Includes the following list of services provided:

initial consultation;
preparation of a set of registration dossier in accordance with the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 "On the Rules for registration and examination of safety, quality and effectiveness of medical devices";
organization, support of tests and research, examination of the result;
support in Roszdravnadzor in case of controversial issues, elimination of comments, appeal of illegal decisions of experts.

Includes the following list of services provided:

initial consultation;
preparation of a set of registration dossier in accordance with the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 "On the Rules for registration and examination of safety, quality and effectiveness of medical devices";
organization, support of tests and research, examination of the result;
support in Roszdravnadzor in case of controversial issues, elimination of comments, appeal of illegal decisions of experts.