医疗器械法规解读

医疗器械法规解读 http://www.shqwsw.com/zhengcefagui/yiliaoqixiefaguijiedu/ Latest 50 infos of 医疗器械法规解读 Copyright(C) Empire CMS Empire CMS by Empire Studio. Thu, 23 Apr 2026 18:42:46 +0000 60 http://www.shqwsw.com/e/data/images/rss.gif 上海启微商务服务有限公司 http://www.shqwsw.com/ <![CDATA[企业申报生产许可开办，生产地址是否要包含研发区域、办公区域？]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-20/1141.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-20/1141.html 医疗器械法规解读 Fri, 19 Dec 2025 16:15:08 +0000 <![CDATA[企业新增生产场地用于定制式义齿的生产，在开展试生产验证时如何选择试生产产品型号？]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-20/1140.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-20/1140.html 医疗器械法规解读 Fri, 19 Dec 2025 16:14:33 +0000 <![CDATA[注册申报资料首次递交时未关联主文档，在补正资料阶段补充关联主文档是否可行？]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1136.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1136.html 医疗器械法规解读 Fri, 19 Dec 2025 15:58:33 +0000 <![CDATA[需清洁处理的无菌医疗器械零配件，末道清洁处理介质有哪些要求？]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1131.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1131.html 医疗器械法规解读 Fri, 19 Dec 2025 15:54:36 +0000 <![CDATA[与无菌医疗器械接触的配件或零部件（原材料）进入净化车间需要做哪些方面的管控？]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1130.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1130.html 医疗器械法规解读 Fri, 19 Dec 2025 15:53:23 +0000 <![CDATA[进口整形美容用透明质酸钠类注射填充剂的上市证明文件中是否需要涵盖申报的适用范围？]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1129.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1129.html 医疗器械法规解读 Fri, 19 Dec 2025 15:52:58 +0000 <![CDATA[幽门螺杆菌耐药基因突变检测试剂注册审查指导原则]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1127.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1127.html 医疗器械法规解读 Fri, 19 Dec 2025 15:49:20 +0000 <![CDATA[人KRAS基因突变检测试剂注册审查指导原则（征求意见稿）]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1126.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1126.html 医疗器械法规解读 Fri, 19 Dec 2025 15:48:35 +0000 <![CDATA[上海市医疗器械生产企业分级监管实施细则》政策解读]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1125.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1125.html 医疗器械法规解读 Fri, 19 Dec 2025 15:48:12 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（下册）第六篇创新医疗器械]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1123.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1123.html 医疗器械法规解读 Fri, 19 Dec 2025 15:46:03 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（下册）：第五篇分类界定]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1122.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1122.html 医疗器械法规解读 Fri, 19 Dec 2025 15:45:39 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（下册）：第四篇医疗器械质量管理体系]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1121.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1121.html 医疗器械法规解读 Fri, 19 Dec 2025 15:45:11 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（下册）：第三篇临床检验产品]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1120.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1120.html 医疗器械法规解读 Fri, 19 Dec 2025 15:44:46 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（下册）第二篇：无源产品]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1119.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1119.html 医疗器械法规解读 Fri, 19 Dec 2025 15:44:22 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（下册）第一篇：有源产品]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1118.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1118.html 医疗器械法规解读 Fri, 19 Dec 2025 15:43:06 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（中册）第五篇分类界定]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1117.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1117.html 医疗器械法规解读 Fri, 19 Dec 2025 15:41:10 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（中册）第二篇：无源产品]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1116.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1116.html 医疗器械法规解读 Fri, 19 Dec 2025 15:40:22 +0000 <![CDATA[《北京市医疗器械审评检查新300问》（中册）第一篇：有源产品]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1115.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1115.html 医疗器械法规解读 Fri, 19 Dec 2025 15:39:15 +0000 <![CDATA[《北京市医疗器械审评检查新300问》——第四篇医疗器械质量管理体系篇]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1114.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1114.html 医疗器械法规解读 Fri, 19 Dec 2025 15:38:26 +0000 <![CDATA[《北京市医疗器械审评检查新300问》——第三篇临床检验产品篇]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1113.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1113.html 医疗器械法规解读 Fri, 19 Dec 2025 15:37:44 +0000 <![CDATA[《北京市医疗器械审评检查新300问》——第二篇无源产品篇]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1112.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1112.html 医疗器械法规解读 Fri, 19 Dec 2025 15:37:04 +0000 <![CDATA[《北京市医疗器械审评检查新300问》——第一篇有源产品篇]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1111.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1111.html 医疗器械法规解读 Fri, 19 Dec 2025 15:33:01 +0000 <![CDATA[有源产品首次注册申报资料要求解读]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1090.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-19/1090.html 医疗器械法规解读 Fri, 19 Dec 2025 15:11:21 +0000 <![CDATA[IVD产品变更注册申报资料要求解读]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1088.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1088.html 医疗器械法规解读 Thu, 18 Dec 2025 14:49:00 +0000 <![CDATA[IVD产品首次注册申报资料要求解读]]> 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/zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1054.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1054.html 医疗器械法规解读 Thu, 18 Dec 2025 13:12:05 +0000 <![CDATA[图解海报 | 《医疗器械生产质量管理规范》系列解读（四）]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1053.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1053.html 医疗器械法规解读 Thu, 18 Dec 2025 13:11:52 +0000 <![CDATA[图解海报 | 《医疗器械生产质量管理规范》系列解读（五）]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1052.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1052.html 医疗器械法规解读 Thu, 18 Dec 2025 13:11:32 +0000 <![CDATA[图解海报 | 《医疗器械生产质量管理规范》系列解读（六）]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1051.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1051.html 医疗器械法规解读 Thu, 18 Dec 2025 13:11:15 +0000 <![CDATA[图解海报 | 《医疗器械生产质量管理规范》系列解读（七）]]> /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1050.html /zhengcefagui/yiliaoqixiefaguijiedu/2025-12-18/1050.html 医疗器械法规解读 Thu, 18 Dec 2025 13:10:58 +0000 <![CDATA[图解海报 | 《医疗器械生产质量管理规范》系列解读（八）]]> 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