醫用口罩混充風險偵測研析   全文下載

Fake Medical Mask Risk Analysis

109年「COVID-19」疫情蔓延全球，口罩成為落實個人防護重要物資之一，國內屢次爆出有不肖廠商將非醫用口罩混充為醫用口罩販售事件，為防範不肖廠商將非醫用口罩混充為醫用口罩販售，本研究運用衛福部食品藥物管理署藥證系統及跨部會巨量資料，透過資料勾稽與大數據分析等方法，偵測口罩混充之風險業者。首先利用財政部關務署海關通關資料找出輸入非醫用口罩業者，後續透過衛福部食品藥物管理署之醫療器材業者登錄資料、經濟部商業司公司基本資料及財政部稅籍資料進行勾稽及比對，取得業者公司基本資料，接著串聯藥證許可資料庫以判別輸入非醫用口罩業者「是否具藥商許可執照」或為「具藥商許可執照申請商之相關企業」，以分析業者是否有「合法掩飾非法」及「非醫用混充醫用」之風險，藉此產出高風險業者清單，提供予稽查單位進行實地稽查，提升稽查效率。截至109年12月31日，使用本研究方法共計查核50家非醫用口罩輸入業者及其相關業者，其中查獲涉嫌違反藥事法或移送檢調者共11家，稽查不合格命中率為22%。衛福部食品藥物管理署透過大數據分析分法，有效偵測輸入口罩之混充風險，守護口罩品質，維護國人健康。

In 2020, COVID-19 spread around the world, and masks have become one of the most important personal protective equipment. It has been reported that dishonest manufacturers sold non-medical masks as medical masks. To prevent dishonest manufacturers from selling fake medical masks, this study reported the use of cross-departmental information to detect the risk of fake medical masks. First, using the customs data from Customs Administration, Ministry of Finance to find out manufacturers importing non-medical masks. Next, concatenating the manufacturers data from Taiwan Food and Drug Administration, Ministry of Health and Welfare and Department of Commerce, Ministry of Economic Affairs and Department of Treasury, Ministry of Finance to obtain the company information. And then connecting the database of medical device license to determine if the manufacturers have Pharmacist selling/ manufacturing license or whose relevant companies have Pharmacist selling/ manufacturing license. Fake medical mask risk was analyzed and the high-risk manufacturers were provided for on-site inspections. As the end of 2020, fifty companies had been inspected, and eleven companies were found suspected of violating the Pharmaceutical Affairs Act or transferred to prosecutors. The unqualified rate was 22%. We used big data analysis methods to effectively detect the risk of fake medical mask, protect the quality of masks, and maintain the health of the people of the country.