聚福彩票
巴西醫療器械質量體系要求

巴西醫療器械質量體系要求(BGMP驗廠)

巴西醫療器械質量體系要求(BGMP)由RDC16:2013規定,該法規的內容類似于ISO13485及美國的QSR820,但細節上也有很大差別,如RDC16特別調工作環境、風險管理等方面的要求。 

B-GMP概述

--申請III、IV類器械ANVISA注冊的制造企業,必須通過BGMP認證(驗廠);

--BGMP由ANVISA具體實施,每2年檢查一次;

--其審查費遠高于歐盟的CE認證費;

--在提交ANVISA認證時提出BGMP審廠申請,進入巴西衛生部排隊系統;

--由于巴西衛生部巴西衛生部的人手有限,相關手續非常復雜,等候審廠的周期有時會長達兩年之久,有的申請者甚至通過法院起訴才贏得審廠機會。

我們的服務

No.階段項目內容
1初步調研了解企業現狀,特別是企業最關注的問題和薄弱環節。
2詳細診斷詳細審查現有文件與現場,提出可操作的整改意見。
3培訓BGMP的理解和實施,BGMP與ISO13485的區別與聯系; 
其他與產品和過程相關的標準培訓。
4一期整改方針、目標、機構、職責、全套流程的整改。
5二期整改操作整改:操作程序的執行與記錄整理。
6內審與管審參與進行內部審核和管理評審。
7三期整改落實內審和管審發現的問題。
8模擬審查模擬BGMP驗廠。
9四期整改糾正模擬驗廠不合格項,迎接BGMP驗廠。
聚福彩票

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