Medical device vigilance systems: India, US, UK, and Australia

Pooja Gupta, Manthan D Janodia, Puralea C Jagadish, Nayanabhirama UdupaManipal Collge of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, IndiaAbstract: The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locall...

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Autores principales:	Pooja Gupta, Manthan D Janodia, Puralea C Jagadish, et al
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2010
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/2649314278fd4faca067815d0bd31156
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spelling	oai:doaj.org-article:2649314278fd4faca067815d0bd311562021-12-02T05:57:15ZMedical device vigilance systems: India, US, UK, and Australia1179-1470https://doaj.org/article/2649314278fd4faca067815d0bd311562010-11-01T00:00:00Zhttp://www.dovepress.com/medical-device-vigilance-systems-india-us-uk-and-australia-a5714https://doaj.org/toc/1179-1470Pooja Gupta, Manthan D Janodia, Puralea C Jagadish, Nayanabhirama UdupaManipal Collge of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, IndiaAbstract: The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.Keywords: medical device, vigilance, regulatory systems, GHTF, India Pooja GuptaManthan D JanodiaPuralea C Jagadishet alDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2010, Iss default, Pp 67-79 (2010)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Pooja Gupta Manthan D Janodia Puralea C Jagadish et al Medical device vigilance systems: India, US, UK, and Australia
description	Pooja Gupta, Manthan D Janodia, Puralea C Jagadish, Nayanabhirama UdupaManipal Collge of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, IndiaAbstract: The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.Keywords: medical device, vigilance, regulatory systems, GHTF, India
format	article
author	Pooja Gupta Manthan D Janodia Puralea C Jagadish et al
author_facet	Pooja Gupta Manthan D Janodia Puralea C Jagadish et al
author_sort	Pooja Gupta
title	Medical device vigilance systems: India, US, UK, and Australia
title_short	Medical device vigilance systems: India, US, UK, and Australia
title_full	Medical device vigilance systems: India, US, UK, and Australia
title_fullStr	Medical device vigilance systems: India, US, UK, and Australia
title_full_unstemmed	Medical device vigilance systems: India, US, UK, and Australia
title_sort	medical device vigilance systems: india, us, uk, and australia
publisher	Dove Medical Press
publishDate	2010
url	https://doaj.org/article/2649314278fd4faca067815d0bd31156
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Medical device vigilance systems: India, US, UK, and Australia

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