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...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2010-01-01
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| Series: | Journal of Advanced Pharmaceutical Technology & Research |
| Subjects: | |
| Online Access: | http://www.japtr.org/article.asp?issn=2231-4040;year=2010;volume=1;issue=2;spage=127;epage=144;aulast=Songara |
| _version_ | 1818571168554156032 |
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| author | Raiendra K Songara Ganesh N Sharma Vipul K Gupta Promila Gupta |
| author_facet | Raiendra K Songara Ganesh N Sharma Vipul K Gupta Promila Gupta |
| author_sort | Raiendra K 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. |
| first_indexed | 2024-12-14T13:52:08Z |
| format | Article |
| id | doaj.art-7945c93c816c48a481e95f210ec1a24c |
| institution | Directory Open Access Journal |
| issn | 2231-4040 0976-2094 |
| language | English |
| last_indexed | 2024-12-14T13:52:08Z |
| publishDate | 2010-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Advanced Pharmaceutical Technology & Research |
| spelling | doaj.art-7945c93c816c48a481e95f210ec1a24c2022-12-21T22:59:01ZengWolters Kluwer Medknow PublicationsJournal of Advanced Pharmaceutical Technology & Research2231-40400976-20942010-01-0112127144Need for harmonization of labeling of medical devices: A reviewRaiendra K SongaraGanesh N SharmaVipul K GuptaPromila 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/article.asp?issn=2231-4040;year=2010;volume=1;issue=2;spage=127;epage=144;aulast=SongaraLabelingMedical deviceRegulatory authority |
| spellingShingle | Raiendra K Songara Ganesh N Sharma Vipul K 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/article.asp?issn=2231-4040;year=2010;volume=1;issue=2;spage=127;epage=144;aulast=Songara |
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