International experience in regulating the medical devices market and possibilities of its use in Russia

Antonov V.S.

doi:https://doi.org/

Antonov V.S.

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

International experience in regulating the medical devices market and possibilities of its use in Russia

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Antonov V.S.

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Journal: Laboratory Service. 2013;(1): 54‑57

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To cite this article:

Antonov VS. International experience in regulating the medical devices market and possibilities of its use in Russia. Laboratory Service. 2013;(1):54‑57. (In Russ.)

Подписка 2025 Лабораторная служба (Laboratory Service)

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Abstract:

To assure the safety and efficacy of medical devices for the innovative development of the sector is a complex, completely unsolved problem in global practice. Significant progress in solving this problem has been made to reform a technical regulation model in the European Union. Consensus about the basic principles and approaches to the state regulation of circulation of medical devices has been now reached in the world. Russia's lag behind in this area is largely associated with difficulties in reforming the Russian technical regulation system.

Keywords:

medical devices

safety

efficacy

circulation

state registration

technical regulation

Authors:

Antonov V.S.

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

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