title: Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.
abstract: The implementation of an effective 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. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.
authors.affiliation: Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, 321 Sec. 2, Kuang Fu Road, Hsinchu 30011, Taiwan.
authors.forename: Tzu-Wei
authors.identifier: 0000-0002-6506-369X
authors.initials: TW
authors.lastname: Li
authors.affiliation: Division of Medical Devices and Cosmetics, Food and Drug Administration, 161-2 Kunyang Street, Nangang District, Taipei City 11561, Taiwan.
authors.forename: Pei-Weng
authors.initials: PW
authors.lastname: Tu
authors.affiliation: Division of Medicinal Products, Food and Drug Administration, 161-2 Kunyang Street, Nangang District, Taipei City 11561, Taiwan.
authors.forename: Li-Ling
authors.identifier: 0000-0002-2655-4891
authors.initials: LL
authors.lastname: Liu
authors.affiliation: Food and Drug Administration, 161-2 Kunyang Street, Nangang District, Taipei City 11561, Taiwan.
authors.forename: Shiow-Ing
authors.initials: SI
authors.lastname: Wu
mesh_terms: D004864:Equipment and Supplies; D006801:Humans; D066192:Manufacturing Industry / Q000379:methods* / Q000592:standards*; D011786:Quality Control; D013624:Taiwan