Medical devices for sale, use and circulation in Russia must obtain a certificate of registration of medical devices and the corresponding GOST-R (DOC) certificate issued by the Russian Ministry of Health.
According to the decree of the Russian Federation, all medical supplies exported to Russia must be registered with the Russian Federal Health Surveillance Agency. Only after obtaining the state registration certificate can they be classified for sale and use.
Decision of the Council of the Eurasian Economic Commission "On approval of the rules of classification of medical devices with regard to the potential risks of their use" was adopted by Decision No. 173 of December 22, 2015;
Order of the Ministry of Health of the Russian Federation "On approval of the nomenclature of medical devices" of June 6, 2012, N 4n. On approval of the nomenclature of medical devices";
GOST 31508-2012 "Basic requirements for classification of medical devices according to the potential risks of their use".
Based on the above regulations, medical devices are categorized as Class 1, low risk, Class 2, medium risk, Class 2b, increased risk, and Class 3 high risk
Most of the medical devices are subject to the GOSTR Declaration of Conformity, and some of the products are subject to the GOSTR Certificate of Conformity, which is based on the GOSTR List of Medical Devices nomenclature. If you can help you can pay attention to Voltaire Certification.