Russia's Ministry of Industry and Trade has proposed introducing a points-based system for assessing the level of localization of selected medical devices and rehabilitation equipment. The draft resolution, now open for public consultation, would amend Government Resolution No. 719.
Under the proposal, manufacturers would earn points for specific production processes and the use of local materials, while minimum localization thresholds would gradually increase over the coming years. The new rules are expected to take effect on January 1, 2026.
According to Baikal Lobridge, the changes could reshape the operating environment for medical device manufacturers, particularly producers of prosthetic and orthopedic products, where imported components still account for up to 60% of production.
Under the proposal, manufacturers would earn points for specific production processes and the use of local materials, while minimum localization thresholds would gradually increase over the coming years. The new rules are expected to take effect on January 1, 2026.
According to Baikal Lobridge, the changes could reshape the operating environment for medical device manufacturers, particularly producers of prosthetic and orthopedic products, where imported components still account for up to 60% of production.
"The government's import substitution policy gives Russian manufacturers and companies with localized production an advantage in public procurement and encourages further investment in domestic manufacturing. At the same time, obtaining localized status is not a one-time procedure. Registration remains valid for only three to five years, after which companies must confirm their compliance again," Baikal Lobridge said.
Manufacturers must also submit annual reports on production and sales by April 1 each year. Failure to do so may lead to products being removed from the state register. Since localization requirements are revised regularly, companies also need to keep adapting their manufacturing processes to stay compliant.
"The success of the new system will largely depend on how well it reflects the realities of the industry. Companies that were not involved in the initial discussions still have time to submit their proposals before the public consultation closes on November 25. Taking industry feedback into account at this stage would help avoid unnecessary costs and make the transition to the new framework more practical for manufacturers," Baikal Lobridge noted.
A similar points-based approach will also be introduced in the pharmaceutical sector from January 1, 2026. The new rules are intended to encourage greater domestic production of medicines and support further technological development across the industry.
Read more in Pharmaceutical Bulletin.
Read more in Pharmaceutical Bulletin.
