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Unregistered In Vitro Diagnostic Medical Devices


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Unregistered in vitro diagnostic medical devices - medical devices intended for the diagnosis of diseases by conducting research on samples of human biological material outside the body, manufactured in a healthcare institution and used in the healthcare institution that produced them1.

  1. Federal Law No. 323-FZ of November 21, 2011 "On the Basics of Health Protection of Citizens in the Russian Federation", as amended on June 22, 2022, Article 38, paragraph 6 // Official Gazette of the Russian Federation. 2011. No. 48. Item 6724. ↩

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