医疗器材临床试验之法规管理与国内现况-财团法人医药品查验中心.pdfVIP

療臨 理 盧 療 UAbstract In order to collect safety and effectiveness data to support a Pre-market Approval (PMA) application, an investigation device exemption (IDE) should be performed for all Class III devices. Only a small percentage of Class II devices require clinical data to support the application. Therefore, the data generated by clinical trial must support the claims that the sponsor intends to make for the marketed device and the clinical utility of the device. Although the regulation of clinical trial for medical device is not well established in Taiwan, the regulation framework of medical device is similar to US FDA. The key to the success of any medical device clinical trial is good advance planning and communication with the regulation authority. In this article, the regulations of the Medical device in US FDA EU and Taiwan are introduced and the requirements for an IDE submission are suggested. Sponsors are also encouraged to contact us to obtain further guidance prior to the submission of an IDE application. 療 () 療療 列勵 療量 行臨療 行臨來臨 行臨臨 數 療臨 臨 不phase I, phase II, phase III and phase IV 行 臨 理不療 療臨 不臨 不臨 不 了 療 念(concept), (prototype), (prepilot), (pilot) 量 (production) 1 行臨來 料(material) 臨 臨 (pilot study) 行(feasibility study) 紐 (pivotal study) (postmarket surveillance study) 行 了 (design definition) 行行數不 若 行 行來 數 行紐 療臨 療 參 了療臨 臨 數 行療臨 聯 類理 療臨 行 行療臨 福療良臨 倫理 量 數 度 行臨 療 行臨 參 年年更 來 行臨若 不理精 神 行 錄不良若 量 來臨 不不論 勵 行臨 論 立 了 療例臨 2 不 療臨 臨 不良 見 臨 療 臨 料 參行臨 數 療理 令 類不 列 療 列來理 療類 度 類例類 例 類 令理 療 理 療 理 療臨 療臨 療都若