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司法部、市场监管总局、药监局负责人就《医疗器械监督管理条例》答记者问

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发布时间：2021-08-25

来源：酯香香化学采购网

　　【化工仪器网政策法规】2021年2月9日，国务院总理李克强签署第739号国务院令，公布修订后的《医疗器械监督管理条例》(以下简称《条例》)。《条例》自2021年6月1日起施行。日前，司法部、市场监管总局、药监局的负责人就《条例》的有关问题回答了记者提问。

　　问：请简要介绍一下《条例》的修订背景。

　　答：医疗器械直接关系人民群众生命健康。党中央、国务院高度重视医疗器械质量安全与创新发展。2000年，国务院制定了《医疗器械监督管理条例》，2014年、2017年分别作了全面修订和部分修改。该《条例》对保障医疗器械质量安全、推动行业健康发展发挥了重要作用。近年来，我国医疗器械产业快速发展，党中央、国务院对药品医疗器械审评审批制度改革作出一系列重大决策部署，2017年10月，中共中央办公厅、国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，对深化医疗器械审评审批制度改革等工作提出具体意见。原《条例》已难以适应新形势需要，有必要进行修订，从制度层面进一步促进行业创新，更好满足人民群众对高质量医疗器械的期待。

　　问：请简要介绍一下《条例》的修订过程。

　　答：2018年5月，市场监管总局向国务院报送《医疗器械监督管理条例修正案(草案送审稿)》。收件后，司法部先后两次书面征求有关部门、地方政府及行业协会、企业意见，并向社会公开征求意见；多次召开企业座谈会和专家论证会，赴四川、湖北、上海、江苏等地实地调研。在此基础上，司法部会同市场监管总局、药监局对送审稿作了反复研究修改，形成了《医疗器械监督管理条例(修订草案)》。2020年12月21日，国务院常务会议审议通过修订草案。2021年2月9日，国务院正式公布《条例》。

　　问：《条例》修订的总体思路是什么？

　　答：修订《条例》在总体思路上主要把握了以下四点：一是落实药品医疗器械审评审批制度改革要求，夯实企业主体责任。二是巩固“放管服”改革成果，优化审批备案程序，对创新医疗器械优先审批，释放市场创新活力，减轻企业负担。三是加强对医疗器械的全生命周期和全过程监管，提高监管效能。四是加大对违法行为的处罚力度，提高违法成本。

　　问：2017年，中办、国办印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，提出推动上市许可持有人制度全面实施。请问《条例》对医疗器械上市许可持有人作了哪些规定？

　　答：医疗器械实行分类管理，第二类、第三类需要取得上市许可，第一类实行备案，《条例》使用了“注册人、备案人”概念，对应上市许可持有人概念。为落实上市许可持有人制度，《条例》作了以下规定：

　　一是明确医疗器械注册人、备案人的定义。取得医疗器械注册证或者办理备案的企业、研制机构为注册人、备案人，对医疗器械研制、生产、经营、使用全过程中的安全性、有效性依法承担责任。二是明确注册人、备案人义务。细化其全过程管理义务，包括建立并有效运行质量管理体系，开展上市后研究和风险管控、不良事件监测和再评价，建立并执行产品追溯和召回制度等。三是厘清注册人、备案人与受托生产企业、电子商务平台经营者、使用单位等其他市场主体的权利义务。

　　问：《条例》在优化营商环境、促进产业创新方面作了哪些规定？

　　答：为落实“放管服”改革要求，进一步减轻企业负担，促进产业高质量发展，《条例》主要规定了以下制度：

　　一是将医疗器械创新纳入发展重点，完善创新体系，在科技立项、融资、信贷、招标采购、医保等方面予以支持，提高自主创新能力。二是加强医疗器械监督管理信息化建设，提高在线政务服务水平，为医疗器械行政许可、备案等提供便利。三是优化审批程序，减少审批材料，允许企业提交自检报告。四是优化备案程序，实行告知性备案、并联备案等。五是对用于治疗罕见疾病、严重危及生命且尚无有效治疗手段的疾病以及应对公共卫生事件等急需的医疗器械，可以附条件批准，加快产品上市。六是对延续注册和临床试验实行默示许可。七是将生产经营许可审查期限由30个工作日缩短为20个工作日。八是明确免于临床评价的情形，提高企业注册申请的效率。九是鼓励医疗机构开展临床试验，将临床试验条件和能力评价纳入医疗机构等级评审。十是允许拓展性临床试验，对符合条件的正在开展临床试验的医疗器械，可免费用于其他病情相同的患者，其安全性数据可用于医疗器械注册申请。

　　问：为应对突发公共卫生事件，《条例》作了哪些专门的制度安排？

　　答：为满足应对重大突发公共卫生事件的需要，加快将急需医疗器械投入使用，《条例》规定了以下制度：

　　一是优先审评审批制度。对创新医疗器械优先审评审批。二是附条件批准制度。对用于治疗罕见疾病、严重危及生命且尚无有效治疗手段的疾病和应对公共卫生事件等急需的医疗器械，可以附条件批准，加快产品上市。三是紧急使用制度。参照疫苗管理法，规定出现特别重大突发公共卫生事件或者其他严重威胁公众健康的紧急事件，可以在一定范围和期限内紧急使用医疗器械。四是临床急需特批进口制度。规定医疗机构因临床急需进口少量第二类、第三类医疗器械的，经国务院药品监督管理部门或者国务院授权的省、自治区、直辖市人民政府批准，可以进口。五是医疗卫生机构研制医疗器械制度。规定医疗卫生机构为应对突发公共卫生事件可以研制医疗器械，管理办法由国务院药品监督管理部门会同国务院卫生主管部门制定。

　　问：《条例》对法律责任作了哪些完善？

　　答：为落实“四个严”要求，提高违法成本，保障人民群众健康，给守法企业营造公平的竞争环境，对原《条例》的法律责任条款主要作了三方面修改：一是大幅提高罚款幅度。特别是对涉及质量安全的违法行为，高可处以货值金额30倍的罚款。二是加大行业和市场禁入处罚力度。为净化市场环境，将严重违法者逐出市场，视违法情节对违法者处以吊销许可证、一定期限内禁止从事相关活动、不受理相关许可申请等处罚措施。三是增加“处罚到人”规定。对严重违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，高可以并处3倍罚款，5年直至终身禁止其从事相关活动。

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[ DB ] CONNECT:[ UseTime:0.000304s ] mysql:host=127.0.0.1;port=3306;dbname=yzncms;charset=utf8
[ SQL ] SHOW COLUMNS FROM `yzn_poster` [ RunTime:0.001014s ]
[ SQL ] SELECT * FROM `yzn_poster` WHERE `cate_id` = 99 AND `p_c_id` = 52 AND `status` = 1 LIMIT 1 [ RunTime:0.000364s ]
[ SQL ] SELECT * FROM `yzn_poster` WHERE `cate_id` = 99 AND `p_c_id` = 55 AND `status` = 1 LIMIT 1 [ RunTime:0.000273s ]
[ SQL ] SHOW COLUMNS FROM `yzn_goods_property` [ RunTime:0.001133s ]
[ SQL ] SELECT `g`.`name`,`p`.`price`,`p`.`unit`,`p`.`type`,`p`.`thumb`,p.id as p_id,`p`.`value`,`p`.`is_where`,`p`.`sku_unit`,`p`.`repeat_type`,`p`.`goods_id` FROM `yzn_goods_property` `p` LEFT JOIN `yzn_goods` `g` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `p`.`recommend` = 1 GROUP BY `p`.`goods_id`,`p`.`repeat_type` ORDER BY `p`.`sort` DESC,`g`.`id` DESC LIMIT 0,15 [ RunTime:0.002387s ]
[ SQL ] SHOW COLUMNS FROM `yzn_goods_category` [ RunTime:0.000822s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `hot_search` = 1 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000396s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `is_show` > 0 AND `status` = 1 ORDER BY `listorder` ASC [ RunTime:0.000305s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `id` IN (1,2,7,16,17,34,92,95,38) [ RunTime:0.000259s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 1 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000242s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 2 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000207s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 7 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000210s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 16 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000220s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 17 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000205s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` IN (34,92) AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000214s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` IN (95,38) AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000243s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 1 AND `status` = 1 [ RunTime:0.000187s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 1 [ RunTime:0.000196s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,1,%' ) [ RunTime:0.000238s ]
[ SQL ] SHOW COLUMNS FROM `yzn_goods` [ RunTime:0.000681s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (25,26,29,30,48,1) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.001024s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 2 AND `status` = 1 [ RunTime:0.000234s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 2 [ RunTime:0.000199s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,2,%' ) [ RunTime:0.000190s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (42,43,2) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000945s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 7 AND `status` = 1 [ RunTime:0.000208s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 7 [ RunTime:0.000196s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,7,%' ) [ RunTime:0.000192s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (10,14,32,33,49,50,51,52,53,54,55,56,57,58,96,97,7) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000959s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 16 AND `status` = 1 [ RunTime:0.000218s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 16 [ RunTime:0.000195s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,16,%' ) [ RunTime:0.000199s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (59,60,61,62,63,16) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000923s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 17 AND `status` = 1 [ RunTime:0.000204s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 17 [ RunTime:0.000195s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,17,%' ) [ RunTime:0.000223s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (40,64,65,66,67,68,100,17) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000913s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 34 AND `status` = 1 [ RunTime:0.000208s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 92 AND `status` = 1 [ RunTime:0.000183s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` IN (34,92) [ RunTime:0.000246s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,34,%' or arrparentid like '0,92,%' ) [ RunTime:0.000218s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (35,70,71,93,94,34,92) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000906s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 95 AND `status` = 1 [ RunTime:0.000215s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 38 AND `status` = 1 [ RunTime:0.000203s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` IN (95,38) [ RunTime:0.000241s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,38,%' or arrparentid like '0,95,%' ) [ RunTime:0.000206s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (47,74,75,76,77,78,79,80,81,82,83,99,95,38) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000908s ]
[ SQL ] SHOW COLUMNS FROM `yzn_article` [ RunTime:0.000873s ]
[ SQL ] SELECT `A`.*,`AD`.*,`C`.`catname` FROM `yzn_article` `A` INNER JOIN `yzn_article_data` `AD` ON `A`.`id`=`AD`.`did` INNER JOIN `yzn_category` `C` ON `C`.`id`=`A`.`catid` WHERE `A`.`id` = 5829 AND `A`.`status` = 1 LIMIT 1 [ RunTime:0.000592s ]
[ SQL ] SHOW COLUMNS FROM `yzn_category` [ RunTime:0.000588s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` = 35 AND `status` = 1 [ RunTime:0.000212s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` IN (36,37,38,39,40,41,42) AND `status` = 1 [ RunTime:0.000206s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` = 43 AND `status` = 1 [ RunTime:0.000173s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` IN (44,45,46,47,48,49,50) AND `status` = 1 [ RunTime:0.000178s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` = 6 AND `status` = 1 [ RunTime:0.000177s ]
[ DB ] CONNECT:[ UseTime:0.000241s ] mysql:host=127.0.0.1;port=3306;dbname=yzncms;charset=utf8
[ SQL ] SELECT `A`.`id`,`A`.`title` FROM `yzn_article` `A` INNER JOIN `yzn_category` `C` ON `C`.`id`=`A`.`catid` WHERE `A`.`status` = 1 AND `A`.`catid` IN (35,36,37,38,39,40,41,42) ORDER BY `A`.`flag` DESC,`A`.`listorder` ASC,`A`.`updatetime` DESC [ RunTime:0.020553s ]
[ SQL ] UPDATE `yzn_article` SET `hits` = `hits` + 1 WHERE `id` = 5829 [ RunTime:0.000328s ]
[ SQL ] SELECT * FROM `yzn_poster` WHERE `cate_id` = 10 AND `p_c_id` = 41 ORDER BY `listorder` ASC LIMIT 4 [ RunTime:0.000390s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 38 AND `a`.`status` = 1 [ RunTime:0.002668s ]
[ SQL ] SELECT `a`.*,`c`.`catname` FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 38 AND `a`.`status` = 1 ORDER BY `flag` DESC,`listorder` ASC,`updatetime` DESC LIMIT 0,6 [ RunTime:0.004607s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 37 AND `a`.`status` = 1 [ RunTime:0.002508s ]
[ SQL ] SELECT `a`.*,`c`.`catname` FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 37 AND `a`.`status` = 1 ORDER BY `flag` DESC,`listorder` ASC,`updatetime` DESC LIMIT 0,6 [ RunTime:0.004906s ]