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
Government Market
Over 80% of medical device turnover in Russia comes from the government sector.
Priority in Tenders
Foreign bids are automatically rejected when at least one Russian-made bid is present.
Contract Price
Government contracts are more favorable by 20% for localized products under GD 1875.
Tax Benefits
VAT exemption on devices and foreign components with Russian-made product status.
Send a Request
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