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Substandard medical device
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Poor-quality medical device - a medical device that does not meet the requirements of safety and effectiveness of medical devices, marking requirements, normative, technical and operational documentation, and which cannot be safely used for the purpose established by the manufacturer (producer)1.
Poor-quality medical device - a medical device that does not meet the requirements of normative, technical and (or) operational documentation of the manufacturer (producer), or in the case of its absence, the requirements of other normative documents2.
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 38, paragraph 13 // Official Compilation of Legal Acts of the Russian Federation. 2011. No. 48. Item 6724. ↩
Federal Law of November 21, 2011 No. 323-FZ "On the Basics of Health Protection of Citizens in the Russian Federation", as amended on August 3, 2018, Article 38, paragraph 13 // RSZ RF. 2011. No. 48. Item 6724. ↩
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