| Need for harmonization of labeling of medical devices: a review. | |
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MedLine Citation:
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PMID: 22247840 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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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Authors:
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Raiendra K Songara; Ganesh N Sharma; Vipul K Gupta; Promila Gupta |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of advanced pharmaceutical technology & research Volume: 1 ISSN: 0976-2094 ISO Abbreviation: J Adv Pharm Technol Res Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2012-01-16 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101537797 Medline TA: J Adv Pharm Technol Res Country: India |
Other Details:
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Languages: eng Pagination: 127-44 Citation Subset: - |
Affiliation:
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School of Pharmaceutical Sciences, Jaipur National University, Jaipur, Rajasthan, India. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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