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Legislative aspects of the development of medical devices.

Maresová, Petra; Klímová, Blanka; Krejcar, Ondrej; Kuca, Kamil.
Ceska Slov Farm; 64(4): 133-8, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26459127
European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.
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