Regulatory base:

1. – Main scheme – Decision of the Council of the Eurasian Economic Commission dated 12 February, 2016, No. 46 “On the Rules for the Marketing Authorisation and Expert Assessment of the Safety, Quality and Efficiency of Medical Devices  
2. – QMS – Decision No. 106 of the Council of the Eurasian Economic Commission dated November 10, 2017 “On Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Management System Depending on Potential Risk of Use” 

Applicable standards: