Laboratory and Clinical Medicine. Pharmacy

Scientific and practical quarterly peer-reviewed journal

 

ISSN 2712-9330 (Online)

  • Continuous numbering: 12
  • Pages: 4-9
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Heading: Journal Bulletin

Assessment and choice of a reference medical organization playing a crucial role on the way to clinical trials for IVDs. A reliable reference medical organization supports to exclude a bloody waste of time, money as well as an image.
An effective coordination of work for providing a clinical trials for IVDs is carried out in the clinical diagnostic laboratory of the Federal State Budgetary Institution ‘National Quality Institute’ of Federal Service for Supervision in the Field of Healthcare.
Zhanna Yu. Sapozhkova – MD, PhD, Head of Clinical Diagnostic Lab of the ‘National Quality Institute’ Federal Service for Supervision in the Field of Healthcare, Moscow, Russia. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Alina Yu. Rodionova – MD Clinical Diagnostic Laboratory of the ‘National Quality Institute’ Federal Service for Supervision in the Field of Healthcare, Moscow, Russia. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Alexander G. Zapolsky – MD, PhD, Director General of the ‘National Quality Institute’ Federal Service for Supervision in the Field of Healthcare, Moscow, Russia. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
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2. Prikaz Minzdrava Rossii ot 30.08.2021 № 885n “Ob utverzhdenii Poryadka provedeniya ocenki sootvetstviya medicinskih izdelij v forme tekhnicheskih ispytanij, toksikologicheskih issledovanij, klinicheskih ispytanij v celyah gosudarstvennoj registracii medicinskih izdelij” (zaregistrirovano v Minyuste Rossii 12.11.2021 N 65787). (In Russ). Available at: http://roszdravnadzor.gov.ru/spec/medproducts/registration/documents/77802 Accessed: 04 May 2024.
3. Federal'nyj zakon ot 21 noyabrya 2011 g. № 323-FZ “Ob osnovah ohrany zdorov'ya grazhdan v Rossijskoj Federa?cii”. (In Russ). Available at: https://minzdrav.gov.ru/documents/7025 Accessed: 04 May 2024.
4. Postanovlenie Pravitel'stva RF ot 27.12.2012 № 1416 “Ob utverzhdenii Pravil gosudarstvennoj registracii medicinskih izdelij”. (v redakcii ot 18.03.2020). (In Russ). Available at: http://www.roszdravnadzor.gov.ru/medproducts/documents/92 Accessed: 04 May 2024.
5. Decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 29 “About Rules of carrying out clinical and clinical laboratory testing (re-searches) of medical products”. Available at: https://docs.eaeunion.org/docs/en-us/01510222/cncd_17052016_29 Accessed: 04 May 2024.
6. Prikaz Minzdrava Rossii ot 16.05.2013 № 300n. “Ob utverzhdenii trebovanij k medicinskim organizaciyam, provodyashchim klinicheskie ispytaniya medicinskih izdelij i poryadka ustanovleniya sootvetstviya medicinskih organizacij etim trebovaniyam”. (In Russ). Available at: http://www.roszdravnadzor.gov.ru/spec/medproducts/control/documents/106 Accessed: 04 May 2024.

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DOI: 10.14489/lcmp.2024.02.pp.004-009
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Use the reference below to cite the publication

Sapozhkova ZhYu, Rodionova AYu, Zapolskiy AG. Reference medical organization for providing a clinical trials for IVDs. Assessment and choice. Laboratory and Clinical Medicine. Pharmacy. 2024;4(2):04-09. (In Russ). DOI: 10.14489/lcmp.2024.02.pp.004-009