我國醫療器材製造廠品質管理系統現況之分析   全文下載

Analysis of The Current Status of The Quality Management System of Medical Device Manufacturers in Taiwan

為使醫療器材管理規定與國際制度接軌，我國參照國際標準組織新版醫療器材品質管理系統標準，訂定醫療器材品質管理系統準則，提升標準可能對部分國內業者造成衝擊，本研究透過新舊條文差異比對及問卷調查結果，探討新版法規對我國符合國際醫療器材品質管理系統規範之影響，以及業者自評能符合國內新訂定醫療器材品質管理系統準則之狀況。

The Regulations of Medical Device Quality Management System (QMS) was published with reference to ISO 13485 (2016 version) to harmonize the requirements with the international standard in Taiwan. The new QMS regulations may have a partial impact on the domestic manufacturers of medical device. Thus, this study compared the new and the old version of QMS regulations, and the analysis the result of questionnaire survey, in order to explores the degree of compliance with international standards and the maintenance of compliance.