NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW

Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user m...

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Main Authors: Rajendra Songara, Ganesh Sharma, Vipul Gupta, Promila Gupta
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2010-06-01
Series:Journal of Advanced Pharmaceutical Technology & Research
Subjects:
Online Access:http://www.japtr.org/Manuscripts/Need%20for%20Harmonization%20of%20Labeling%20of%20Medical%20Devices%20A%20Review.pdf
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author Rajendra Songara,
Ganesh Sharma,
Vipul Gupta,
Promila Gupta
author_facet Rajendra Songara,
Ganesh Sharma,
Vipul Gupta,
Promila Gupta
author_sort Rajendra Songara,
collection DOAJ
description Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.
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spelling doaj.art-b4d364686c2c4aaeb63a6047bcc2a9d92022-12-22T02:54:42ZengWolters Kluwer Medknow PublicationsJournal of Advanced Pharmaceutical Technology & Research0976-20942010-06-0112127144NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEWRajendra Songara,Ganesh Sharma,Vipul Gupta,Promila GuptaMedical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.http://www.japtr.org/Manuscripts/Need%20for%20Harmonization%20of%20Labeling%20of%20Medical%20Devices%20A%20Review.pdfLabelingMedical deviceRegulatory authority.
spellingShingle Rajendra Songara,
Ganesh Sharma,
Vipul Gupta,
Promila Gupta
NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW
Journal of Advanced Pharmaceutical Technology & Research
Labeling
Medical device
Regulatory authority.
title NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW
title_full NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW
title_fullStr NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW
title_full_unstemmed NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW
title_short NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW
title_sort need for harmonization of labeling of medical devices a review
topic Labeling
Medical device
Regulatory authority.
url http://www.japtr.org/Manuscripts/Need%20for%20Harmonization%20of%20Labeling%20of%20Medical%20Devices%20A%20Review.pdf
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