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干貨丨體外診斷試劑注冊檢驗流程的要點分析(二)
[2019-03-14]

體外診斷試劑在上市前,藥監部門要對其合法性進行檢驗監督,合法性包括擬上市產品的安全性、有效性等。只有經過了一系列的檢驗驗證,產品才能上市。

注冊檢驗流程


4.申請抽樣

? ? 產品抽樣由相應藥品監督管理部門進行。

申請產品抽樣需提供的材料:體外診斷試劑注冊檢驗樣品抽樣申請表、注冊產品技術要求、擬注冊產品說明書、產品生產環境及工藝說明、擬抽樣產品生產批記錄(必要時提供)、真實性符合性聲明、經辦人授權委托書和經辦人身份證。

5.現場抽樣

1)確定抽樣時間

遞交抽樣申請后,確認到廠抽樣時間,一般為申請后一周左右。

2)布置現場

現場抽樣前布置好現場,準備好產品相關資料、抽樣單及封簽,安排好接待工作。

3)現場檢查

記錄抽樣老師在檢查過程中提出的問題,并有針對性的給予整改措施。

4)簽字確認

抽樣結束后,需要抽樣人員及公司負責人在抽樣單和封簽上簽字,并在相應位置蓋上抽樣單位和被抽樣單位的公章,將抽樣樣品核對裝箱后貼好封簽。

6.送檢

(1)抽樣完成后,與檢驗機構溝通并確認送檢時間;

(2)隨時對檢驗進度進行跟蹤;

(3)檢測中心出具檢測報告及產品技術要求的預評價意見。

注意:《體外診斷試劑注冊管理辦法》第二十五條規定,有國家標準品、參考品的產品應當使用國家標準品、參考品進行注冊檢驗。

7.注冊檢驗文件整理

注冊檢驗結束后,注意:

(1)注冊檢驗相關文件文檔的完整齊全;

(2)總結工作流程經驗和注意事項,避免錯誤的再次發生和提高工作效率。

注意


本文只對于按醫療器械管理的體外診斷試劑(包括在疾病的預測、預防、診斷、治療監測、預后觀察和健康狀態評價的過程中,用于人體樣本體外檢測的試劑、試劑盒、校準品、質控品等產品;可以單獨使用,也可以與儀器、器具、設備或者系統組合使用)的注冊檢驗具有參考意義。按照藥品管理的用于血源篩查的體外診斷試劑和采用放射性核素標記的體外診斷試劑的注冊檢驗請勿參考本文。






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