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href="http://www.ngjyjd.com/news/54.html">注册äº?/a>制度试点工作的通知 </span><span style="font-family:宋体;font-size:19.5000pt;"></span> </p> </td> </tr> <tr> <td valign="center" style="border:none;"> <p class="MsoNormal" align="center" style="text-align:center;"> <span style="font-family:"mso-fareast-font-family:宋体;color:#333333;font-size:13.5000pt;"><span style="font-size:14px;">åQˆå›½è¯ç›‘械注ã€?/span><span style="font-size:14px;">2019</span><span style="font-size:14px;">ã€?/span><span style="font-size:14px;">33</span><span style="font-size:14px;">åøP¼‰ </span></span><span style="font-family:宋体;font-size:13.5000pt;"></span> </p> </td> </tr> <tr> <td valign="center" style="border:none;"> <p class="MsoNormal"> <span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;">北京、天‹z¥ã€æ²³åŒ—、辽宁、黑龙江、上‹¹—÷€æ±Ÿè‹ã€æµ™æ±Ÿã€å®‰å¾½ã€ç¦å»ºã€å±±ä¸œã€æ²³å—、湖北、湖南、广东、广è¥Ñ€æ“v南、重庆、四川、云南、陕西省åQˆè‡ªæ²ÕdŒºã€ç›´è¾–市åQ‰è¯å“ç›‘督管理局åQ?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"><span style="font-size:14px;"> 为深入诏彻落实中å…׃¸­å¤®åŠžå…¬åŽ…、国务院办公厅印发的《关于深化审评审批制度改革鼓åŠÞp¯å“åŒ»ç–—器械创新的意见》(厅字ã€?/span><span style="font-size:14px;">2017</span><span style="font-size:14px;">ã€?/span><span style="font-size:14px;">42</span><span style="font-size:14px;">åøP¼‰åQŒåŠ å¿«æŽ¨˜q›åŒ»ç–—器æ¢îCñ”业创新发展,为全面实施医疗器械注册äh制度˜q›ä¸€æ­¥ç§¯ç´¯ç»éªŒï¼Œåœ¨ä¸Š‹¹—÷€å¹¿ä¸œã€å¤©‹z¥è‡ªè´¸åŒºå¼€å±•åŒ»ç–—器械注册äh制度试点工作的基¼‹€ä¸Šï¼Œå›½å®¶è¯å“ç›‘督½Ž¡ç†å±€åQˆä»¥ä¸‹ç®€¿U°å›½å®¶å±€åQ‰å†³å®šè¿›ä¸€æ­¥æ‰©å¤§åŒ»ç–—器械注册äh制度试点工作åQŒçŽ°ž®†æœ‰å…³äº‹™åšw€šçŸ¥å¦‚下åQ?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> </span><b><span style="font-size:14px;">一、试点范å›?/span></b><b><span style="font-size:10.5pt;"><br /> </span></b><span style="font-size:14px;"> 北京、天‹z¥ã€æ²³åŒ—、辽宁、黑龙江、上‹¹—÷€æ±Ÿè‹ã€æµ™æ±Ÿã€å®‰å¾½ã€ç¦å»ºã€å±±ä¸œã€æ²³å—、湖北、湖南、广东、广è¥Ñ€æ“v南、重庆、四川、云南、陕西省åQˆè‡ªæ²ÕdŒºã€ç›´è¾–市åQ‰ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> </span><b><span style="font-size:14px;">二、试点内容和目标</span></b><b><span style="font-size:10.5pt;"><br /> </span></b><span style="font-size:12pt;"><span style="font-size:14px;"> åQˆä¸€åQ‰æŽ¢ç´¢å¾ç«‹åŒ»ç–—器械委托生产管理制度,优化资源配置åQŒè½å®žä¸»ä½“责仅R€‚医疗器械注册申请ähåQˆä»¥ä¸‹ç®€¿U?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">甌™¯·äº?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">åQ‰ç”³è¯·åƈ取得åŒÈ–—器械注册证的åQŒæˆä¸ºåŒ»ç–—器械注册ähåQˆä»¥ä¸‹ç®€¿U?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">注册äº?/span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">åQ‰ã€‚申请äh可以委托具备相应生äñ”能力的企业生产样品,注册人可以将已获证äñ”品委托给具备生äñ”能力的一家或者多家企业生产äñ”品。鼓励集团公叔R€šè¿‡æ³¨å†Œäººåˆ¶åº¦è¯•ç‚¹è¿›ä¸€æ­¥æ•´åˆã€ä¼˜åŒ–资源配¾|®ï¼Œè½å®žåŒÈ–—器械注册äºÞZ¸»ä½“责仅R€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäºŒåQ‰æŽ¢ç´¢å¾ç«‹å®Œå–„的注册人医疗器械质量管理体¾p»ï¼Œæ˜Žç¡®åŒÈ–—器械注册人、受托äh½{‰ä¸»ä½“之间的法律关系åQŒåœ¨è´£ä“Q清晰、风险可控的基础上,构徏注册人全生命周期质量½Ž¡ç†åˆ¶åº¦å’Œä½“¾p…R€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"><span style="font-size:14px;"> åQˆä¸‰åQ‰æŽ¢ç´¢åˆ›æ–°åŒ»ç–—器械监½Ž¡æ–¹å¼ï¼Œæœ‰æ•ˆè½å®ž</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">监管工作一定要跟上</span><span style="font-size:14px;">â€?/span><span style="font-size:14px;">的要求,完善事中事后监管体系åQŒåŽ˜æ¸…跨区域监管责ä“QåQŒåŞ成完善的跨区域协同监½Ž¡æœºåˆÓž¼Œå¢žå¼ºç›‘管合力åQŒæå‡ç›‘½Ž¡æ•ˆèƒ½ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆå››åQ‰æŽ¢ç´¢é‡Šæ”‘ÖŒ»ç–—器械注册äh制度¾U¢åˆ©åQŒé¼“励医疗器械创斎ͼŒæŽ¨åŠ¨åŒÈ–—器械产业高质量发展ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäº”åQ‰ç§¯ç´¯åŒ»ç–—器械注册äh制度试点¾léªŒåQŒäؓ全面推进实施åŒÈ–—器械注册人管理制度提供重要支撑ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> 属于原国安™£Ÿå“è¯å“ç›‘督管理æ€Õd±€å‘布的禁止委托生产医疗器械目录的产品åQŒæš‚不列入试炏V€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> </span><b><span style="font-size:14px;">三、注册äh条äšg和义务责ä»?/span></b><b><span style="font-size:10.5pt;"><br /> </span></b><span style="font-size:14px;"> åQˆä¸€åQ‰æ³¨å†Œäh条äšg</span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">1.</span><span style="font-size:14px;">住所或者生产地址位于参与试点的省、自æ²ÕdŒºå’Œç›´è¾–市内的企业、科研机构ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">2.</span><span style="font-size:14px;">具备专职的法规事务、质量管理、上市后事务½{‰å·¥ä½œç›¸å…³çš„技术与½Ž¡ç†äººå‘˜åQŒå…·æœ‰åŒ»ç–—器械监½Ž¡æ³•è§„和标准相关知识和经验ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">3.</span><span style="font-size:14px;">建立与äñ”品相适应的质量管理体¾pÕdƈ保持有效˜qè¡ŒåQŒæœ‰å¯¹è´¨é‡ç®¡ç†ä½“¾pȝ‹¬ç«‹è¿›è¡Œè¯„估、审核和监督的äh员ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">4.</span><span style="font-size:14px;">具备承担åŒÈ–—器械质量安全责ä“Q的能力ã€?</span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäºŒåQ‰æ³¨å†Œäh的义务责ä»?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">1.</span><span style="font-size:14px;">依法承担åŒÈ–—器械设计开发、äÍ床试验、生产制造、销售配送、售后服务、äñ”品召回、不良事件报告等环节中的相应法律责ä“Qã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">2.</span><span style="font-size:14px;">与受托生产企业签订委托合同和质量协议åQŒæ˜Ž¼‹®å§”托生产中技术要求、质量保证、责ä»Õdˆ’分、放行要求等责ä“QåQŒæ˜Ž¼‹®ç”Ÿäº§æ”¾è¡Œè¦æ±‚和产品上市放行方式ã€?</span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">3.</span><span style="font-size:14px;">加强对受托生产企业的监督½Ž¡ç†åQŒå¯¹å—托生äñ”企业的质量管理能力进行评伎ͼŒå®šæœŸå¯¹å—托生产企业开展质量管理体¾p»è¯„估和审核ã€?</span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">4.</span><span style="font-size:14px;">加强不良事äšg监测åQŒæ ¹æ®é£Žé™©ç­‰¾U§å¾ç«‹åŒ»ç–—器械相应的˜q½æº¯½Ž¡ç†åˆ¶åº¦åQŒç¡®ä¿åŒ»ç–—器æ¢îCñ”品可满èƒö全程˜q½æº¯çš„要求ã€?</span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">5.</span><span style="font-size:14px;">可以自行销售医疗器梎ͼŒä¹Ÿå¯ä»¥å§”托具有相兌™µ„质的åŒÈ–—器械¾lè¥ä¼ä¸šé”€å”®ã€‚自行销售的注册人应当具备规定的åŒÈ–—器械¾lè¥èƒ½åŠ›å’Œæ¡ä»Óž¼›å§”托销售的åQŒåº”当签订委托合同,明确各方权利义务ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">6.</span><span style="font-size:14px;">通过信息化手ŒDµï¼Œå¯¹ç ”发、生产、销售和不良事äšg监测情况˜q›è¡Œå…¨æµ½E‹è¿½æº¯ã€ç›‘控ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">7.</span><span style="font-size:14px;">¼‹®ä¿æäº¤çš„ç ”½I¶èµ„料和临床试验数据真实可靠、系¾lŸå®Œæ•´ã€å¯˜q½æº¯ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:12.0000pt;"> </span><b><span style="font-size:14px;"> 四、受托生产企业条件和义务责ä“Q</span></b><b><span style="font-size:10.5pt;"><br /> </span></b><span style="font-size:14px;"> åQˆä¸€åQ‰å—托生产企业条ä»?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">1.</span><span style="font-size:14px;">住所或者生产地址位于参与试点的省、自æ²ÕdŒºå’Œç›´è¾–市内的企业ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">2.</span><span style="font-size:14px;">具备与受托生产医疗器械相适应的质量管理体¾pÕd’Œç”Ÿäñ”能力ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäºŒåQ‰å—托生产企业义务责ä»?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">1.</span><span style="font-size:14px;">承担《医疗器械监督管理条例》、以及其他相å…Ïx³•å¾‹æ³•è§„以及委托合同、质量协议规定的义务åQŒåƈ承担相应的法律责仅R€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">2.</span><span style="font-size:14px;">按照åŒÈ–—器械相关法规规定以及委托合同、质量协议约定的要求¾l„织生äñ”åQŒå¯¹æ³¨å†Œäºø™´Ÿç›¸åº”质量责ä“Qã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">3.</span><span style="font-size:14px;">发现上市后医疗器械发生重大质量事故的åQŒåº”当及时报告所在地省çñ”药品监管部门ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">4.</span><span style="font-size:14px;">受托生äñ”¾lˆæ­¢æ—Óž¼Œå—托生äñ”企业应当向所在地省çñ”药品监管部门甌™¯·å‡å°‘åŒÈ–—器械生äñ”许可所附生产äñ”品登记表中登载的受托产品信息ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> <span style="font-size:14px;">5.</span><span style="font-size:14px;">受托生äñ”企业不得再次转托ã€?/span></span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> </span><b><span style="font-size:14px;">五、办理程åº?/span></b><b><span style="font-size:10.5pt;"><br /> </span></b><span style="font-size:14px;"> åQˆä¸€åQ‰æ³¨å†Œç”³è¯—÷€‚注册申请äh提交åŒÈ–—器械注册甌™¯·çš„,向相应药品监½Ž¡éƒ¨é—¨æäº¤æ³¨å†Œç”³è¯¯‚µ„料,¾lå®¡æŸ¥ç¬¦åˆè¦æ±‚çš„åQŒæ ¸å‘医疗器械注册证åQŒåŒ»ç–—器械注册证中登载的生äñ”地址为受托生产地址的,备注栏标注受托企业名¿U°ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäºŒåQ‰ç”Ÿäº§è®¸å¯åŠžç†ã€‚受托生产企业不具备相应生äñ”资质的,可提交注册äh的医疗器械注册证甌™¯·ç”Ÿäñ”许可或者申è¯ïL”Ÿäº§è®¸å¯å˜æ›ß_¼Œè·¨åŒºåŸŸè¯•ç‚¹çš„向受托生产企业所在地省çñ”药品监管部门提交ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆä¸‰åQ‰ç”Ÿäº§åœ°å€ç™»è®°äº‹é¡¹å˜æ›´åŠžç†ã€‚对于注册äh拟通过委托生äñ”方式变更注册证生产地址的,由受托生产企业所在地省çñ”药品监管部门会同注册人所在地省çñ”药品监管部门开展现场核查,òq¶ç”±å—托生äñ”企业所在地省çñ”药品监管部门变更《医疗器械生产许可证》。注册äh提交受托生äñ”企业变更后《医疗器械生产许可证》和委托协议向相应药品监½Ž¡éƒ¨é—¨åŠžç†ç™»è®îCº‹™å¹å˜æ›´ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆå››åQ‰å—托备案。受托生产企业应当向所在地省çñ”药品监管部门备案åQŒå¤‡æ¡ˆæ—¶åº”当提交委托合同、质量协议等资料ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:12pt;"> </span><b><span style="font-size:14px;">六、工作要æ±?/span></b><b><span style="font-size:10.5pt;"><br /> </span></b><span style="font-size:14px;"> åQˆä¸€åQ‰åŠ å¼ºç»„¾l‡åè°ƒã€‚国家局负责¾l„织全国åŒÈ–—器械注册人制度试点工作。各试点省çñ”药品监管部门要成立由分管局领导担ä“Q¾l„长的试点工作组åQŒç ”½I¶æ‹Ÿå®šè¯•ç‚¹å·¥ä½œå®žæ–½æ–¹æ¡ˆå’Œç›¸å…³½Ž¡ç†åˆ¶åº¦åQŒå®Œå–„工作机åˆÓž¼ŒåŠ å¼ºåŠ›é‡æŠ•å…¥åQŒåŠ å¼ø™Œä¸šåŒ–、专业化‹‚€æŸ¥å‘˜é˜Ÿä¼å»ø™®¾åQŒæ‰Žå®žæŽ¨˜q›è¯•ç‚¹å·¥ä½œå¼€å±•ã€‚各试点省çñ”药品监管部门¾l“合本地åŒÈ–—器械产业和监½Ž¡æƒ…况,在充分调研论证的基础上尽快制定试点工作方案,及时上报国家局ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäºŒåQ‰å¼ºåŒ–监督管理。各¾U§è¯å“ç›‘½Ž¡éƒ¨é—¨åº”当加强对注册人åï–行保证医疗器械质量、上市销售与服务、医疗器æ¢îC¸è‰¯äº‹ä»¶ç›‘‹¹‹ä¸Žè¯„ä­h、医疗器械召回等义务情况的监督管理。涉及跨区域试点的,各省¾U§è¯å“ç›‘½Ž¡éƒ¨é—¨è¦åœ¨åè°ƒä¸€è‡´çš„基础上,¼‹®å®šè·¨åŒºåŸŸç›‘½Ž¡å„方职责划分,落实日常监管责ä“Qä¸ÖM½“åQŒç¡®ä¿å¯¹åŒÈ–—器械全生命周期全链条监管无缝隙无死角。要建立协同½Ž¡ç†ã€ä¿¡æ¯å…±äº«ä¸Ž¾l“果互认机制。对为医疗器械研制、生产、经营、ä‹É用等‹zÕdŠ¨æä¾›äº§å“æˆ–者服务的其他相关单位åQŒè¯å“ç›‘½Ž¡éƒ¨é—¨å¯ä»¥è¿›è¡Œåšg伸检查ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆä¸‰åQ‰é¼“åŠÞq¤¾ä¼šå‚与。各试点省çñ”药品监管部门要充分发挥行业协会的作用åQŒé€šè¿‡è¡Œä¸šåä¼šå……分听取企业意见和徏议;¾l„织法律专家研究赯‚‰å§”托协议范本åQ›é¼“åŠÞq¤¾ä¼šåŠ›é‡ä»¥é€‚当形式¿U¯æžå‚与企业质量责ä“Q保证能力å»ø™®¾ã€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆå››åQ‰æŽ¨åŠ¨ä¿¡æ¯å…±äº«ã€‚各试点省çñ”药品监管部门应当按规定主动公开òq¶åŠæ—¶å‘国家局报送试点工作进展和新情å†üc€?/span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span style="font-size:14px;"> åQˆäº”åQ‰åŠæ—¶æ€È»“¾léªŒã€‚各试点省çñ”药品监管部门要全½E‹å…³æ³¨è·Ÿítªè¯•ç‚ÒŽƒ…况,及时æ€È»“åQŒå¯¹å–得成效和面临问题进行分析,òq¶åŞ成解军_¾è®®ï¼ŒåŠæ—¶ä¸ŠæŠ¥å›½å®¶å±€ã€?/span><span style="font-family:宋体;font-size:12.0000pt;"></span> </p> <p class="MsoNormal" align="right" style="text-align:right;"> <span style="font-size:14px;">国家药监局</span><span style="font-family:"mso-fareast-font-family:宋体;color:#000000;font-size:10.5000pt;"><br /> </span><span 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