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Antonov V.S.

FGBU "Tsentr monitoringa i kliniko-ékonomicheskoĭ ékspertizy" Roszdravnadzora, Moskva

Interchangeability of medical products

Authors:

Antonov V.S.

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Journal: Laboratory Service. 2012;(3): 21‑26

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To cite this article:

Antonov VS. Interchangeability of medical products. Laboratory Service. 2012;(3):21‑26. (In Russ.)

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The information on the interchangeability of medical products is highly valuable: it can correlate most exactly medical products with medical technologies and the standards of medical care and optimize the expenditure of budgetary funds allocated for public procurements. The proposed procedure to determine interchangeability is based on criteria for the equivalence of uses, that of functional technical and technological characteristics, and that of the efficacy of functional medical items.

Keywords:

medical products
interchangeability
equivalence
types of medical products
nomenclature classification

Authors:

Antonov V.S.

FGBU "Tsentr monitoringa i kliniko-ékonomicheskoĭ ékspertizy" Roszdravnadzora, Moskva

List of references:

  1. Dorofeev V.L. Podkhody k otsenke vzaimozamenyaemosti lekarstvennykh sredstv. Remedium 2011; 12: 51-59.
  2. ISO 15225:2000. Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange.
  3. ISO 15225:2010. Medical devices - Quality management - Medical device nomenclature data structure.
  4. GMDN: www.gmdnagency.com/
  5. GHTF Position Statement: Single Global Nomenclature System for Medical Devices - http://www.ghtf.org/about/statement-gmdn.html
  6. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
  7. US Food and Drug Administration: Premarket Notification (510k) - http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
  8. Efremova T.F. Sovremennyi tolkovyi slovar' russkogo yazyka. AST 2006.
  9. Prikaz Minzdravsotsrazvitiya Rossii №735 ot 30.10.2006 "Ob utverzhdenii Administrativnogo reglamenta Federal'noi sluzhby po nadzoru v sfere zdravookhraneniya i sotsial'nogo razvitiya po ispolneniyu gosudarstvennoi funktsii po registratsii izdelii meditsinskogo naznacheniya".
  10. Medical device regulations. Global overview and guiding principles. WHO, 2003, Glossary, p.viii.

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