Articles liés à Global Medical Device Regulation: Emphasis on Active...

Global Medical Device Regulation: Emphasis on Active Implants: USFDA, EMEA and ANVISA - Couverture souple

Patel, Keyur N.; Trivedi, Kandarp N.; Raval, Bhuvan P.

 
9783659445736: Global Medical Device Regulation: Emphasis on Active Implants: USFDA, EMEA and ANVISA
Couverture souple
ISBN 10 : 3659445738 ISBN 13 : 9783659445736
Editeur : LAP LAMBERT Academic Publishing, 2013

Synopsis

Regulations for medical devices in EU Member countries are governed by European Medicine Evaluation Authority, popularly known as EMEA. As per EMEA's guideline each member country has to strictly follow the common guidelines with exception to rules and regulation that are modified by state authorities but must be in conformity with EMEA Guideline. Regulations posed in here are further divided in implantable and active implantable medical devices thereafter where manufacturing, testing and distribution can only be done once it is CE marked. In case of non CE marked devices i.e. non-EU member manufacturer, market authorisation process shall be completed prior to approval and separately. For brazil market that is governed by ANVISA, medical devices are classified into four different classes. There is no independent discrimination made for Active implantable medical devices but most non invasive devices are covered in Class I. While those which are to be connected with blood storage and other devices are classified into class II. Class III devices are those which are connected or included with wounds or healthy tissues.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l'auteur

Keyur N. Patel (M.Pharm)and Kandarp N. Trivedi(M.Pharm) is a Post Graduate Student at Faculty of Phamacy, Shri Satsangi Saket Dham Ram Ashram Group of Institutes, Vadasma. Dr.Bhuvan P. Raval, M.Pharm, PGDPRA, MBA, FSAB, FICPHS, D. Lit is an Asst. Professor at Faculty of Phamacy, Shri Satsangi Saket Dham Ram Ashram Group of Institutes, Vadasma.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2013
Langue
anglais
ISBN 10 
3659445738
ISBN 13 
9783659445736
Reliure
Broché
Nombre de pages
144
Coordonnées du fabricant
non disponible
Personne responsable
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