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【浙江】（附注冊證轉移制度匯總）《關于簡化省外已上市第二類醫療器械遷入我省注冊申報指南（試行）》
截至2023年7月18日，已有11個省份實行注冊證轉移制度，其中浙江為新增省份，湖南注冊證轉移制度已于2022年6月取消此政策。
【浙江】（附注冊證轉移制度匯總）《關于簡化省外已上市第二類醫療器械遷入我省注冊申報指南（試行）》
【京津冀】《京津冀醫療器械注冊質量管理體系核查跨區域現場檢查工作指導原則（試行）》
《京津冀醫療器械注冊質量管理體系核查跨區域現場檢查工作指導原則（試行）》
【京津冀】《京津冀醫療器械注冊質量管理體系核查跨區域現場檢查工作指導原則（試行）》
【CMDE】國家藥監局器審中心關于發布腹腔內窺鏡手術系統技術審評要點（2023年修訂版）的通告（2023年第18號）
器審中心發布腹腔內窺鏡手術系統技術審評要點，該產品分類編碼為01-07-03，管理類別為Ⅲ類。
【CMDE】國家藥監局器審中心關于發布腹腔內窺鏡手術系統技術審評要點（2023年修訂版）的通告（2023年第18號）
【會議通知】醫療器械歐盟MDR &中國臨床試驗技術研討會
歡迎各位企業參加瑞旭集團聯合北京倍力醫療于2023年5月26日舉辦的“醫療器械歐盟MDR &中國臨床試驗技術研討會”。
【會議通知】醫療器械歐盟MDR &中國臨床試驗技術研討會
【CMDE】關于發布2023年度醫療器械注冊審查指導原則編制計劃的通告（2023年第6號）
國家藥品監督管理局醫療器械技術審評中心發布Ⅱ/Ⅲ類醫療器械注冊審查指導原則編制計劃
【CMDE】關于發布2023年度醫療器械注冊審查指導原則編制計劃的通告（2023年第6號）
【CMDE】國家藥監局器審中心關于發布超聲軟組織手術設備注冊審查指導原則（2023年修訂版）的通告（2023年第4號）
本指導原則為《醫療器械分類目錄》中子目錄為01有源手術器械，分類編碼為01-01-01的指導原則，有需求企業可在原文中直接下載。
【CMDE】國家藥監局器審中心關于發布超聲軟組織手術設備注冊審查指導原則（2023年修訂版）的通告（2023年第4號）
《企業落實醫療器械質量安全主體責任監督管理規定》解讀
《企業落實醫療器械質量安全主體責任監督管理規定》解讀
《企業落實醫療器械質量安全主體責任監督管理規定》解讀
【會議通知】2022醫療器械法規年度報告
歡迎各企業參加瑞旭集團-北京西爾思科技有限公司于2023年1月12日舉辦的“2022醫療器械法規年度報告”。
【會議通知】2022醫療器械法規年度報告
【NMPA】國家藥監局關于醫用透明質酸鈉產品管理類別的公告（2022年第103號）
為加強醫用透明質酸鈉（玻璃酸鈉）產品的監督管理，進一步規范相關產品注冊（備案），保證公眾用藥用械安全有效，根據《藥品管理法》《醫療器械監督管理條例》相關規定，國家藥監局發布關于醫用透明質酸鈉產品管理類別的公告。
【NMPA】國家藥監局關于醫用透明質酸鈉產品管理類別的公告（2022年第103號）
【收藏】各省醫療器械注冊證轉移簡化政策匯總
本文整理了11個省份關于醫療器械注冊證轉移簡化的政策匯總，供企業收藏
【收藏】各省醫療器械注冊證轉移簡化政策匯總
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