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醫療器械臨床評價
依據《醫療器械監督管理條例》及相關法規要求，醫療器械產品注冊申報過程應當進行臨床評價，即采用科學合理的方法對臨床數據進行分析評價，以確認醫療器械在其適用范圍下的安全性、臨床性能和有效性。
醫療器械臨床評價分為注冊申報臨床評價和上市后臨床評價，其臨床評價的臨床數據主要來源于臨床文獻、境內外臨床試驗和臨床經驗。其中列入“免于臨床評價醫療器械目錄”中的醫療器械產品可免于進行臨床評價，在注冊申報時提交與免臨床目錄及同類已上市產品的對比表。
醫療器械臨床評價路徑
醫療器械臨床評價流程（非臨床試驗方式）
臨床評價流程 | 工作內容 |
一、臨床評價評估與計劃 | - 注冊申報產品技術資料及非臨床研究資料收集 - 同品種產品境內外上市情況及不良事件等數據收集 - 產品相關臨床文獻及技術指導原則收集 - 注冊申報產品與同品種產品對比與差異性分析 - 審評咨詢與確認 - 臨床評價方案制訂 |
二、臨床評價啟動與實施 | - 臨床評價項目討論會 - 臨床與非臨床研究資料收集 - 文獻檢索 - 臨床文獻數據分析 - 差異性分析與說明 - 臨床評價報告撰寫初稿 |
三、臨床評價報告審核與整改 | - 臨床評價報告審核會 - 審評咨詢或專家咨詢 - 臨床評價報告修改 - 補充臨床試驗（必要時） - 臨床評價報告定稿 |
四、臨床評價報告補正 | - 臨床評價報告注冊發補內容確認 - 臨床評價報告補正資料準備 - 審評跟進與回復 |
我們的服務
臨床評價路徑確認
注冊申報臨床評價報告撰寫
臨床試驗方案設計與報告撰寫
定期風險評價報告撰寫
上市后臨床評價或臨床試驗
真實世界臨床試驗
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