Assurance of Medical Device Quality with Quality Management System An Analysis of Good Manufacturing Practice Implementation in Taiwan文档.pdf

Hindawi Publishing Corporation BioMed Research International Volume 2015, Article ID 670420, 7 pages /10.1155/2015/670420 Review Article Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan Tzu-Wei Li,1 Pei-Weng Tu,2 Li-Ling Liu,3 and Shiow-Ing Wu4 1 Oice of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, 321 Sec. 2, Kuang Fu Road, Hsinchu 30011, Taiwan 2Division of Medical Devices and Cosmetics, Food and Drug Administration, 161-2 Kunyang Street, Nangang District, Taipei City 11561, Taiwan 3Division of Medicinal Products, Food and Drug Administration, 161-2 Kunyang Street, Nangang District, Taipei City 11561, Taiwan 4Food and Drug Administration, 161-2 Kunyang Street, Nangang District, Taipei City 11561, Taiwan Correspondence should be addressed to Tzu-Wei Li; alberttwli@.tw Received 11 September 2014; Revised 4 December 2014; Accepted 4 December 2014 Academic Editor: Josef Jampilek Copyright © 2015 Tzu-Wei Li et al. his is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. he implementation of an efective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. he present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical