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FDA驗廠概況

FDA-QSR820驗廠

美國的醫療器械法規體系

       美國食品藥品監督管理局(FDA)是負責醫療器械管理的政府機構。其根據各相關法律授權而制定的各類法規性的文件編號為21CFRxxxx(xxxx為阿拉伯數字)。其中21CFR820是FDA根據《聯邦食品,藥品和化妝品法案》第501,502,510,513,514,515,518,519,520,522,701,704,801,803條款的授權而制定的規范醫療器械企業質量體系要求的法規,即Quality System Regulation,簡稱QSR或QSR820.

QSR820

       --又稱21CFR820,是美國醫療器械質量管理體系法規的英文縮寫,因其位于美國聯邦法規(Code of Federal Regulations)第21卷第820部分,故名;

       --QSR820是美國(人用)醫療器械制造商以及擬將產品銷往美國的外國(人用)醫療器械制造商必須遵守的質量管理體系法規,是多數醫療器械在美國上市之前必須遵守、上市之后隨時可能抽查的基本要求,這種抽查即通常所說的FDA醫療器械QSR820驗廠

       --符合性檢查:無論誰(FDA,或第三方機構)對工廠實施檢查,都只是一個(針對相關法規的)符合性檢查,不頒發任何證書,不屬于認證活動。

誰應該遵守QSR820?

       21QSR820.1規定:所有在美國和波多黎哥境內的,或有產品出口到美國和波多黎哥境內的醫療器械企業,必須按QSR820的要求建立質量體系,企業可根據實際情況,滿足QSR中與本企業制造活動相關的條款。

QSR820不適用

       --不適用于醫療器械零件生產商,但鼓勵這類企業以QSR820中適用的條款為指導;

       --不適用于人血和血制品生產商,這類企業應遵循21CFR606的規定。

誰負責驗廠

       FDA下屬的CDRH(器械與放射健康中心)是專職負責醫療器械企業管理的政府機構,其根據FDA的授權,安排檢查員到各企業進行工廠檢查。

驗廠抽查原則

       --根據法律規定,對未豁免QSR 820的產品的生產企業,進行例行檢查;(大多數情況)

       --II類器械或有510(K)注冊的器械的企業,容易被抽到;

       --為國外大公司做OEM的企業;

       --產品在美國市場發生質量事故的企業。

檢查頻率及費用

       美國境內企業:一般每兩年檢查一次;

       美國境外企業:不定期檢查;

       所有檢查費用由FDA承擔。

第三方機構代為審查

       在歐洲和美國本土(不適用于中國及港澳臺企業),FDA也授權第三方機構進行工廠檢查,委托企業需支付相應費用。這種委托第三方的檢查只是個別的,僅適于FDA檢查過并且無問題的企業,FDA對企業的首次工廠檢查不委托任何第三方進行。

驗廠指南

       QSIT(質量體系檢查技術)是FDA檢查員的必修課程,也是FDA Quality Systems Inspection Reengineering Team專門編制的檢查員手冊,詳細說明FDA審核員的檢查方法、關注點。

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