Compliance of medical devices is confirmed by way of declaration.
Medical devices are declared according to the RF Government Regulation dated December 1, 2009 N 982 as consistent with the consolidated list of products being confirmed by way of declaration of compliance.
This type of declaration is known as GOST P declaration.
Moreover, electrical medical devices require a declaration of the Customs Union according to the technical regulations of the Customs Union On Electromagnetic Compliance of Technical Means (ТР ТС 020/2011).
Declaration is issued based on the testing protocols and a registration certificate (RC) by the Ministry of Health of the Russian Federation.
We provide testing services and registration of medical devices at Roszdravnadzor.