Registration of medical devices in the Eurasian Economic Union

Mikhailyuk, Sorokolat and Partners would like to inform you that the procedure for submitting applications for registration of medical devices according to the new regulations of the Eurasian Economic Union has been launched.

The first applications for their registration according to the rules of the EAEU have been filed to the authorized bodies of Kazakhstan and Russia.

According to Decision No. 46 "On Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices" determined by the Council of the Eurasian Economic Commission of February 12, 2016 in order to register any medical device in the EAEU it is necessary to conduct the complex studies in the authorized research institutions located on the territory of the Eurasian Economic Union.

The registration certificate for a medical device is issued for an unlimited period of time.

Upon your request we will be pleased to provide you with the detailed information about the associated costs as well as the list of required documents and the Power of Attorney form for execution. For any aditional information please contact our specialists from the Regulatory Affairs Department.