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News Digest 19.09.2025 — 26.09.2025
26.09.2025
Roszdravnadzor to Tighten Oversight of Medical Device Manufacturers; The President extended the ban on the export of medical devices from the country for several years; Information about the Manufacturer's Authorized Representative (MAR): New Requirements for Current Registration Certificates
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News Digest 12.09.2025 — 19.09.2025
19.09.2025
Medical Glove Labeling Postponed Until March 2026; Transition to a single medical device market will be delayed by two years; Medical device manufacturers are asking people to pay attention to the assortment of marketplaces
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News Digest 05.09.2025 — 12.09.2025
12.09.2025
The validity period of national procedures for registration of medical devices is extended by 2 years; The EEC Council clarified the rules for registration and examination of medical devices; Glucometers, tonometers, endoprostheses and reagent kits will be included in the list of labeling
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News Digest 29.08.2025 — 05.09.2025
05.09.2025
Bionic prostheses included in the "second extra" list; The schedule for creating megascience facilities and nuclear medicine complexes will change; An updated version of the domestic ECMO device Ex-Stream is getting ready to enter the market
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News Digest 22.08.2025 — 29.08.2025
29.08.2025
Roszdravnadzor has approved a new procedure for maintaining a register of clinical trials of medical devices; Changes have been prepared to the rules for marking for the purchase of medical devices; The Ministry of Industry and Trade proposed integrating the EIS and the GIS MT in terms of exchanging data on the labeling of medical devices
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News Digest 15.08.2025 — 22.08.2025
22.08.2025
Foreign manufacturers of medical devices have had their registration dossier updated postponed; Russian medtech earned almost 30 billion rubles in six months; ECOlab invested 500 million rubles in expanding production in the Moscow region
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News Digest 08.08.2025 — 15.08.2025
15.08.2025
Experience on labeling medical devices extended until 2026; The list of medical devices for palliative care at home has been updated; The list for simplified registration of medical devices includes stretchers and gurneys
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News Digest 01.08.2025 — 08.08.2025
08.08.2025
The Ministry of Health has lowered the risk class for alcohol wipes; A manufacturer of medical devices has succeeded in overturning a decision to certify a measurement method in court; Chinese scientists will work on the creation of a space hospital
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News Digest 25.07.2025 — 01.08.2025
01.08.2025
The Ministry of Industry and Trade will extend the simplified procedure for declaring a number of pharmaceutical products for a year; Former deputy head of Kamchatka Ministry of Health sentenced to 14 years in prison; AI assistant from SberHealth showed 93% diagnostic accuracy
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