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Unfavorable Events
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Adverse events — monitoring the safety of medical devices, registration of side effects not mentioned in the instructions for use or operating manual of a medical device, adverse reactions during its use, characteristics of interactions between medical devices, facts and circumstances that create threats to the lives and health of citizens and healthcare workers when using and operating medical devices1.
Federal Law No. 323-FZ of November 21, 2011 "On the Basics of Health Protection of Citizens in the Russian Federation", as amended on May 11, 2021, Article 14, paragraph 15 // Official Gazette of the Russian Federation. 2011. No. 48. Item 6724. ↩
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