Legislative aspects of the development of medical devices

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F15%3A50003808" target="_blank" >RIV/62690094:18450/15:50003808 - isvavai.cz</a>

Result on the web

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DOI - Digital Object Identifier

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Result language

angličtina

Original language name

Legislative aspects of the development of medical devices

Original language description

European industry of medical device technologies represents 30% of all world's sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leadsto the earlier patient's 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 medicaldevices 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 Chinain 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.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

AE - Management, administration and clerical work

OECD FORD branch

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Project

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Continuities

S - Specificky vyzkum na vysokych skolach

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Česká a slovenská farmacie

ISSN

1210-7816

e-ISSN

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Volume of the periodical

64

Issue of the periodical within the volume

4

Country of publishing house

CZ - CZECH REPUBLIC

Number of pages

5

Pages from-to

133-138

UT code for WoS article

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EID of the result in the Scopus database

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