What are "medical devices"?
“Medical devices” (medical products) include any instruments, apparatus, devices, equipment, materials and other products which are:
- used for medicinal purposes either on their own or in combination with each other or with other items required for using the products in accordance with their purpose, including special software, and
- intended by the manufacturer for prevention, diagnostics, treatment and medical rehabilitation of illnesses, the monitoring of human body, performance of medical research, recuperation, replacement or alteration of human anatomy or physiological functions, prevention or termination of pregnancy;
and the functional purpose of which is not performed by pharmacological, immunological, genetic or metabolic treatment of human body.
(Article 38 of Law on the Principles of Citizens' Health Protection in the Russian Federation, No. 323-FZ of 21 November 2011).
Registration requirement for medical devices in Russia
Only registered medical devices may be placed on the Russian market (Article 38 of Law on the Principles of Citizens' Health Protection in the Russian Federation, No. 323-FZ of 21 November 2011).
The Rules and procedure for the state registration of medical devices in Russia were adopted by Decree No. 1416 of 27 December 2012.
Exemption from the registration requirement
No registration is required for medical devices which are manufactured pursuant to individual orders of patients and to which special requirements apply and which are intended exclusively for the use by one patient (Article 38 (5) of Law on the Principles of Citizens' Health Protection in the Russian Federation, No. 323-FZ of 21 November 2011).