Medical Device Localization in Russia under Gov. Decree 719
Full route from analysis of the foreign device to Russian production with Russian-made product status and Roszdravnadzor registration.
Six Project Phases
Device Assessment
Analysis of Gov. Decree 719 requirements, score calculation and valoric share assessment
Roadmap
Technology transfer, component sourcing and Russian supplier selection
Documentation
Adaptation of design documentation to Russian standards, Minpromtorg package
Production
Process and QMS organisation per ISO 13485 at a qualified production site
ST-1 & Registry
Origin confirmation, inclusion in Minpromtorg registry
GISP Annual
Annual reporting support until April 1 each year — no risk of cancellation
Key Benefits
Import-dominated market
Russian-made products accounted for 32% of the Russian medical device market in 2025, with a market size of RUB 876.6 bn (RT-MedTech, Rostec estimate).
Annex 1 positions
For positions in Annex 1 to GD 1875, foreign goods are not admitted to procurement.
Annex 2 positions
For positions in Annex 2 to GD 1875, bids with goods from outside the EAEU are rejected if a bid with Russian or EAEU goods has been found compliant with the procurement requirements. For some positions two such bids are required (“3rd excluded”).
Price Preference in Procurement
For goods not included in Annexes 1 and 2 to GD 1875, bids with Russian-made products receive a preference in price evaluation.
Calculate Your Ad Valorem Share
⚠️ This calculator is simplified and accounts only for the import component share — the full Gov. Decree 719 methodology also factors in technological operations performed in Russia. In addition, from July 1, 2026 new Gov. Decree 719 requirements (Decree 351) are increasingly introduced via a points-based system for specific product positions rather than through changes to the ad valorem threshold — check which model applies to your product category. Learn more (in Russian): how to calculate the ad valorem share under Gov. Decree 719.
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