歐、美、日醫療器材檢驗管理制度之比較分析

A Study of Medical Device Testing & Regulatory Systems of EC、USA and JAPAN

杜培文(Pei-Weng Tu) ； 戴世傑(Shyh-Jye Tai) ； 黃明權(Ming-Chuan Huang) ； 張柏林(Ber-Lin Chang)

《藥物食品檢驗局調查研究年報》 17號 (1999/09) Pp. 37-50

https://doi.org/10.6946/ASRNL.199909.0037

摘要

為期充分保障消費者安全，並使我國醫療器材檢驗管理制度更臻完善，本計畫於八十六年七月至八十七年六月間蒐集世界上科技較為進步，制度較為優秀之歐盟、美國及日本醫療器材檢驗管理制度相關資料，加以分析比較，經由擷取國外制度之精華，並考量國內實際狀況之方式，提出：1．擬訂醫療器材上市前核備制度2．加速醫療器材再分類、研擬特定醫療器材檢驗管理規範3．修改醫療器材上市前檢驗規定4．制訂醫療器材上市後傷害、副作用報告系統5．適當運用非官方機構之資源等五項建議供主管機關參考。

關鍵字

醫療器材 ； 檢驗管理制度 ； 上市前核備制度

並列摘要

In order to protect consumers and to unify with systems of other countries, a study on the testing of medical devices regulatory systems of the European Community, USA and Japan was conducted during a period from July 1997 to June 1998. By adopting the beneficial elements of foreign systems and also considering local situation in our country, we proposed five suggestions to the Department of Health: 1.the establishment of a pre-market notification requirement for medical devices. 2.to speed up the reclassification process of medical devices and to set up testing requirement for specified medical devices. 3.to modify the pre-market testing regulation of medical devices. 4.to establish a post-market surveillance system for medical devices and 5.the appropriate application of human resources of non-official organization.

並列關鍵字

medical devices ； testing & regulating system ； pre-market notification requirement