Registration of medical devices in Russia
Registration of medical devices is a state procedure, the purpose of which is to allow the release of only high-quality and safe medical products, which have been tested in accordance with applicable norms and standards, to the market of the Russian Federation.
Only after passing the registration procedure, manufacturers get access to the circulation of products in Russia.
What types of medical devices need to be registered?
Any instruments, machines, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer (producer) for the prevention, diagnosis, medical treatment and medical rehabilitation in the case of diseases, monitoring the state of the human body, carrying out medical research, restoring, replacing, changing the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, the functional purpose of which is not implemented through pharmacological, immunological, genetic or metabolic effects on the human body, are subject to state registration.
According to Resolution of the Government of the Russian Federation No. 1416 dated 27 December 2012 “On Approval of the Rules for the State Registration of Medical Devices” (as amended and supplemented)
The list of medical devices subject to state registration includes the following categories of products:
- Equipment / devices / machines for medical treatment and rehabilitation
- Equipment / devices / machines for diagnostics and prevention
- Devices for patient monitoring and self-control;
- Devices and tools for restoring, replacing or changing human physiological functions and anatomy
- Medical device software