我國輸入醫療器材製造廠品質系統文件審查結果分析   全文下載

The Result of Quality System Documents Review of Foreign Medical Device Manufacturers in Taiwan

為強化醫療器材之管理，我國「醫療器材管理法」已於2021年5月1日施行。本研究針對2023年度輸入醫療器材製造業者品質系統文件審查申請案，分析其審查結果、缺失分佈及不予核備原因。結果顯示，多數醫療器材商申請輸入製造廠品質系統文件審查尚能符合要求並取得製造許可；另由不予核備案件結果可見，常見缺失類別主要為原廠說明函、文件總覽表及醫療器材檔案清單等未能符合要求。分析結果可供衛生福利部食品藥物管理署舉辦業者說明會及專家座談會參考，針對分析結果之缺失類別加強宣導，用以精進我國醫療器材製造品質的管理綜效與審查品質。

To strengthen the management of medical devices, the“Medical Device Management Act”was implemented on May 1, 2021. This study analyzes the review results, classification of deficiencies, and reasons for disapproval of quality system document review applications submitted by medical device firm in 2023. The results show that the majority of manufacturers can fulfill the requirements of document review and obtain manufacturing approval. In addition, common deficiency categories found from the review results of disapproval applications are mainly original manufacturer’s declaration, document master lists, and lists of medical device files. The analysis results can serve as references for Taiwan Food and Drug Administration in organizing training activities for the industry. By strengthening advocacy regarding the categories and patterns of deficiencies identified in the analysis results, we can enhance the comprehensive effectiveness and review quality of medical device manufacturing quality management.