Registration is subject to any tools, apparatus, 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 designed by the manufacturer for the prevention, diagnosis, treatment and rehabilitation of diseases, monitoring human organism state, medical research, reduction, substitution, modification of anatomical structure or physiological function of the body, preventing or interrupting pregnancy which function is realized by pharmacological, immunological , genetic or metabolic effects on the human body (hereinafter referred to as medical devices).
Medical devices manufactured according to individual orders of patients with special requirements prescribed by medical workers and which are intended exclusively for personal use by a particular patient.
|Grades 1 and 2a||
|Grades 2b and 3||
Registration certificates for medical devices and medical equipment of unlimited duration issued before the effective date of this resolution are valid and must be replaced by January 1, 2021 with registration certificates in the form approved by the Federal Service for Supervision in the Field of Health.
The registration certificate is replaced without going through the state registration of medical devices on the basis of an application submitted by the applicant to the Federal Service for Supervision of Health Care, indicating the information provided for by the Rules approved by Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416.
It is worth paying attention to the fact that now it is necessary to indicate the product code in Russian Classification of Products by Economic Activities 2!
What can be modified: