The Ministry of Industry and Trade has prepared a project on a point system for evaluating medical products in order to increase the share of Russian components and deepen localization
The Ministry of Industry and Trade of the Russian Federation proposed amendments to the appendix to the Decree of the Government of the Russian Federation No. 719 of July 17, 2015, which consists in establishing a point system for assessing criteria for determining the level of localization of the medical devices production.
The purpose of the proposed changes is to gradually increase the percentage of Russian components used in the production of medical devices. This should serve as an additional factor for the development of domestic production in Russia and reduce dependence on imports.
The list of medical products that are proposed to be evaluated using a point system includes:
reagent kits for in vitro diagnostics (including for various analyzers);
disinfectants, antiseptics and disinfectants;
needles, catheters and cannulas;
microsurgical instruments for ophthalmology;
splints and other devices for treating fractures;
prostheses of blood vessels and heart valves;
and other products.
The criteria for evaluation and scoring will be the degree of localization of individual technological operations and quality control of both individual components for production and the product as a whole. The minimum required total number of evaluation points required to recognize a medical product as domestic will gradually increase every year, starting from 2024 to 2026.
In addition, mandatory requirements (for which no points are awarded) will be:
availability of technical documentation for production of products for a period of at least five years;
carrying out scientific and development work;
Quality Management System;
availability of production space;
share of minimal technological operations.
The corresponding draft resolution of the Government of the Russian Federation is posted on the website of the Federal Project of Regulatory Legal Acts. It is currently in the public consultation stage.
The measures considered will make it possible to stimulate the transfer of production of a wide range of medical products to the territory of the Russian Federation.