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Need for harmonization of labeling of medical devices: a review.
MedLine Citation:
PMID:  22247840     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Raiendra K Songara; Ganesh N Sharma; Vipul K Gupta; Promila Gupta
Publication Detail:
Type:  Journal Article    
Journal Detail:
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:
Created Date:  2012-01-16     Completed Date:  2012-10-02     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  101537797     Medline TA:  J Adv Pharm Technol Res     Country:  India    
Other Details:
Languages:  eng     Pagination:  127-44     Citation Subset:  -    
Affiliation:
School of Pharmaceutical Sciences, Jaipur National University, Jaipur, Rajasthan, India.
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