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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
News Digest 17.04.2026 — 24.04.2026
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24.04.2026
Roszdravnadzor has developed regulations for registering medical devices in accordance with EAEU rules; A simplified procedure for importing goods from the EAEU without labeling will not affect medicines and medical devices; Compression garment production launched in Technopolis Moscow SEZ with 250 million rubles
News Digest 10.04.2026 — 17.04.2026
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17.04.2026
Requirements for Inspection of Medical Device Production in the Eurasian Economic Union (EAEU) Approved; Prostheses and test strips now fall under a point-based localization system; Japanese liquor giant announces acquisition of Daiichi Sankyo subsidiary
News Digest 03.04.2026 — 10.04.2026
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10.04.2026
The Russian Government has expanded the list of medical devices subject to labeling; The Ministry of Labor will update the regulatory framework for the technical rehabilitation equipment (TRE) market; Russia's first telemedicine stethoscope has received a patent in the United States
News Digest 27.03.2026 — 03.04.2026
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03.04.2026
Roszdravnadzor to Update Consultation Procedures for Medical Device Registration; A Ministry of Health commission rejected all applications for the inclusion of new medical devices in the compulsory medical insurance (CMI) lists; The government intends to reduce the share of illegal medical device trafficking to 21% by 2030
News Digest 20.03.2026 — 27.03.2026
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27.03.2026
The Federal Center for Planning and Organization of Drug Provision for Citizens (FCDPiLO) may be appointed responsible for purchasing drugs and medical devices for national projects; Continuous glucose monitoring systems will be centralized for procurement; Rostec Registers New Anesthesia and Respiratory Machine with Intelligent Control