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News Digest 26.06.2026 — 03.07.2026
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03.07.2026
Roszdravnadzor will receive greater powers in registering medical devices; The Russian Government has revised localization thresholds for X-ray equipment; Certain medical devices will be excluded from the Procedure for Providing Medical Care for Transplantation
News Digest 19.06.2026 — 26.06.2026
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26.06.2026
Roszdravnadzor Approves Regulations for Issuing Extracts from the State Register of Medical Devices; The Russian Ministry of Health has proposed amending the rules for importing medical devices for vital indications; The Russian Ministry of Health will update the procedure for calculating the initial contract price for medical devices
News Digest 11.06.2026 — 19.06.2026
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19.06.2026
Roskachestvo has identified issues with the registration and accuracy of blood pressure monitors; The Russian Ministry of Health has developed new instructions on how to handle citizen appeals; Revenue threshold for transition to VAT will be frozen until 2029
News Digest 05.06.2026 — 11.06.2026
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11.06.2026
The Russian Government has amended the rules for maintaining the state register of medical devices; The Russian Ministry of Health has increased the number of medical specialties to 155; The Russian Government will allocate an additional 5 billion rubles for the purchase of glucose monitoring systems
News Digest 29.05.2026 — 05.06.2026
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05.06.2026
The rule regarding the cancellation of registration of medical devices without an authorized representative is proposed to be postponed for a year; The Russian Ministry of Health has updated its procedures for monitoring the safety of medical devices and assessing their conformity; Amendments have been made to the Medical Device Safety Monitoring Procedure
News Digest 22.05.2026 — 29.05.2026
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29.05.2026
Roszdravnadzor Warns of Mandatory Update of Medical Device State Registration Service; New rules have been approved for the import of unregistered medical devices; The Government will regulate the import of medical devices into Russia for specific patients
News Digest 15.05.2026 — 22.05.2026
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22.05.2026
The Eurasian Economic Commission (EEC) Council Amends Requirements for Quality Management Systems for Medical Devices; Issuance of permits for the use of in vitro diagnostic medical devices has been transferred to digital format; Roszdravnadzor's territorial offices will be granted new powers to license medical device maintenance
News Digest 30.04.2026 — 15.05.2026
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15.05.2026
The procedure for transferring data on AI-enabled medical devices to the automated information system (AIS) has been updated; Roszdravnadzor (Federal Service for Surveillance in Healthcare) has identified mandatory information for medical device regulatory documentation; Roszdravnadzor has cancelled paper forms for registration certificates for medical devices
News Digest 24.04.2026 — 30.04.2026
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30.04.2026
The Russian government was asked to maintain VAT exemptions for medical device manufacturers; The Russian Ministry of Labor will establish pricing procedures for the procurement of technical rehabilitation equipment; The Deputy Minister of Industry and Trade of the Russian Federation visited Russia's first plant producing medical devices for dialysis