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News Digest 21.11.2025 — 28.11.2025
28.11.2025
EAEU regulations will expand the permissible cases for the circulation of unregistered medical devices; The Government Expanded Risk Categories for Medical Device Inspections; The government has clarified the labeling parameters for disposable technical rehabilitation devices
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News Digest 14.11.2025 — 21.11.2025
21.11.2025
Roszdravnadzor has developed regulations for issuing extracts from the state register of medical devices; Roszdravnadzor has changed its decision on vending machines; Evgeny Nifantyev proposed measures to prevent the sale of uncertified medical devices on marketplaces
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News Digest 07.11.2025 — 14.11.2025
14.11.2025
Russia to Launch Post-Market Quality Monitoring of Urological Medical Devices; The Moscow Department of Health has included medical devices and therapeutic nutrition products in its regulations for the use of electronic prescriptions; Expanding the "second-odd-person" rule could increase healthcare facilities' costs
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News Digest 01.11.2025 — 07.11.2025
07.11.2025
The Russian Association of Pharmacy Chains (RAAC) has called for the introduction of labeling for another group of products; The VAT payment threshold for simplified taxation systems will be lowered in stages; Russia's first dialysis equipment manufacturing plant is scheduled to open in March
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News Digest 24.10.2025 — 01.11.2025
01.11.2025
94 medical devices will be added to the localization point system; Russia to extend special rules for the circulation of medicines and medical devices until the end of 2027; NMIC status may become available to pharmaceutical companies
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News Digest 17.10.2025 — 24.10.2025
24.10.2025
The transition to a single market for medical devices in the Eurasian Economic Union (EAEU) will be postponed for two years; The Russian Ministry of Health has compiled a list of medical equipment for the modernization of regional cancer centers; The manufacturer of ELTA glucometers has challenged Roszdravnadzor's claims in court
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News Digest 10.10.2025 — 17.10.2025
17.10.2025
Roszdravnadzor will tighten oversight of the use of medical artificial intelligence; GOST for medical electrical devices supplemented with EAEU requirements; Russia plans to centralize procurement of drugs and medical devices for national projects
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News Digest 03.10.2025 — 10.10.2025
10.10.2025
The ban on the export of pharmaceuticals and medical devices has been extended until the end of 2027; The Ministry of Finance clarified the country of origin validation procedure for polymer medical devices; Regulators have been instructed to more strictly monitor customer bids for public procurement of medical devices
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News Digest 26.09.2025 — 03.10.2025
03.10.2025
The sale of medical devices through vending machines may be illegal; The Ministry of Industry and Trade has proposed amending the list of goods eligible for parallel imports; BSS Pharmaceutical Holding Acquires Two Medical Device Distributors
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