我國醫療器材製造業者品質管理系統查核結果分析   全文下載

The Analysis of Medical Device Manufacturer’s Quality Management Systems in Taiwan

為提升醫療器材製造業者之品質管理系統能力，以保障國人使用醫療器材之安全及效能，並因應國際醫療器材管理法規快速變化趨勢，我國參酌國際標準化組織公告之ISO 13485:2016，建立新版醫療器材品質管理相關法規。本研究旨在探討醫療器材製造業者品質管理系統之概況，分析各縣市取得製造許可數量、品項分布與常見查核缺點。結果顯示近半數查核缺點與產品實現有關，其中以「生產與製程管制」章節為缺點之主要來源。相關研究資料可供衛生福利部食品藥物管理署（下稱食藥署）更了解國內製造業者符合新版醫療器材品質管理系統法規之現況，進而有效運用稽查資源，以強化國內醫療器材管理制度。

To improve the quality management abilities of medical device manufacturers, as well as to harmonize the quality management requirements with international standards, the Taiwan Food and Drug Administration (TFDA) announced new medical device regulations that incorporate international standards specific for medical device quality management systems issued by the International Organization for Standardization (ISO 13485:2016). This research aimed to investigate current state of the medical device industry in Taiwan, including number of authorized manufacturers, distribution of medical device categories, and common nonconformities. The results showed that nearly half of the nonconformities were related to“Product Realization”, with the“Production and Process Control”issues being the primary source of nonconformities. Overall, this study can provide information on the current compliance status of domestic manufacturers with the new regulations, thereby TFDA can more effectively allocate inspection resources and reinforce the domestic medical device management system.