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200个！创新性医疗器械获批

分类：成果 2023-05-19 16:42:30 21阅读次数

5月11日，国家药品监督管理局官网发布，批准了一个名称为“自膨式可载粒子胆道支架”的医疗器械产品注册。

至此，我国已有200个创新性强、技术含量高、临床需求迫切的创新医疗器械产品获批上市。

为切实鼓励医疗器械创新，2014年，国家药监局发布《创新医疗器械特别审批程序（试行）》，设置了创新医疗器械快速审批通道。

随后相继出台了《医疗器械优先审批程序》，启动了注册人制度试点，上线了医疗器械注册电子申报信息化系统，通过一系列的改革加速构建有利于医疗器械产业创新发展的监管体系，促进产业高质量发展。

自此，我国的创新医疗器械产业发展开始走入快车道。

据悉，已经获批的200个创新医疗器械产品核心技术都有我国的发明专利权或者发明专利申请已经国务院专利行政部门公开，产品主要工作原理/作用机理为国内首创，具有显著的临床应用价值。

医疗器械产业加速，北京获批最多

从已批准的200个产品其所在地来看，创新医药器械主要集中在北京、上海、广东、江苏、浙江等省市。北京市的数量最多，共有57个，其次是上海市34个、广东省32个、江苏省27个。

按进口国别来看，有美国、韩国、以色列等三个国家，其中所在地为美国的进口创新医疗器械获批数量最多。

按年度来看，创新医疗器械获批数量呈逐年加速上升状态，尤其是最近三年增长较快。2020年批准26个，2021年批准35个，而2022年批准数量达到了55个，比上一年增加了57.1%。

从企业获批产品数量来看，北京品驰医疗设备、微创医疗集团、联影医疗等三家企业（同一集团下合并计算）获得批准的创新医疗器械数量最多。

外资企业中，美敦力获批的创新医疗器械数量最多。

标签：医疗器械

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[8]未定义数组索引: page
[8]未定义数组下标: 0
[2]Declaration of app\common\model\News::getAllList($filter = Array, $limit = 16, $order = Array, $with = Array) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\Company::getAllList($filter = Array, $limit = 20) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8]未定义数组索引: center
[8]Only variables should be passed by reference
[2]Declaration of app\common\model\NewsComment::getAllList($filter = Array, $limit = 16) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8192]Function create_function() is deprecated
[8192]Function create_function() is deprecated
[8]未定义数组索引: area
[8]未定义数组索引: st
[2]Declaration of app\common\model\Topic::getList($filter = Array) should be compatible with app\common\model\BaseModel::getList($filter = Array, $sort = Array)
[2]Declaration of app\common\model\Topic::getAllList($filter = Array, $field = 'id,md5,tit...', $limit = 0) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\TopicInfoList::getAllList($filter = Array, $limit = 8) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8]未定义数组索引: center
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[2]Declaration of app\common\model\Tag::getAllList($filter = Array, $with = Array, $limit = 5) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\Tag::remove($filter) should be compatible with app\common\model\BaseModel::remove($filter = Array)
[8]未定义数组索引: goods_list
[8]未定义数组下标: 0
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: E
[8]未定义数组索引: -
[8]未定义数组索引: wtt_list

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[ SQL ] SHOW COLUMNS FROM `news_category` [ RunTime:0.000956s ]
[ SQL ] SELECT `id`,`name` FROM `news_category` WHERE `is_show` = 1 [ RunTime:0.000243s ]
[ SQL ] SELECT * FROM `news_category` WHERE `parent_id` = 0 AND `is_show` = 1 ORDER BY `sort` ASC,`id` DESC [ RunTime:0.000295s ]
[ SQL ] SHOW COLUMNS FROM `company` [ RunTime:0.000940s ]
[ SQL ] SHOW COLUMNS FROM `news` [ RunTime:0.001011s ]
[ SQL ] SELECT * FROM `news` WHERE `md5` = 'abf74e453d156a92' AND `review_status` = 1 LIMIT 1 [ RunTime:0.000320s ]
[ SQL ] SHOW COLUMNS FROM `user_info` [ RunTime:0.001002s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` = 1 [ RunTime:0.000960s ]
[ SQL ] SELECT * FROM `company` WHERE `id` = 0 [ RunTime:0.000238s ]
[ SQL ] SHOW COLUMNS FROM `news_text` [ RunTime:0.000693s ]
[ SQL ] SELECT * FROM `news_text` WHERE `news_id` = 564 [ RunTime:0.029931s ]
[ SQL ] SHOW COLUMNS FROM `news_belong_category` [ RunTime:0.000969s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 564 [ RunTime:0.001948s ]
[ SQL ] SELECT * FROM `news_category` WHERE `id` IN (5) [ RunTime:0.000185s ]
[ SQL ] SHOW COLUMNS FROM `user_follow` [ RunTime:0.000854s ]
[ SQL ] SELECT `id` FROM `user_follow` WHERE `user_id` IS NULL AND `follow_user_id` = 1 LIMIT 1 [ RunTime:0.000225s ]
[ SQL ] SHOW COLUMNS FROM `news_comment` [ RunTime:0.000745s ]
[ SQL ] SELECT * FROM `news_comment` WHERE `news_id` = 564 AND `parent_id` = 0 ORDER BY `id` DESC [ RunTime:0.000207s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `news_comment` WHERE `news_id` = 564 LIMIT 1 [ RunTime:0.000180s ]
[ SQL ] SELECT * FROM `news` WHERE `is_show` = 1 AND `review_status` = 1 AND `id` IN (564,533,19,817,7037,6798,6775,6670,6531,5958) ORDER BY field(id,564,533,19,817,7037,6798,6775,6670,6531,5958) [ RunTime:0.001394s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (1,172,12,13,503,293,225) [ RunTime:0.000904s ]
[ SQL ] SHOW COLUMNS FROM `topic` [ RunTime:0.001159s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `topic` WHERE `review_status` = 1 ORDER BY `id` DESC LIMIT 4 [ RunTime:0.000193s ]
[ SQL ] SHOW COLUMNS FROM `topic_info_list` [ RunTime:0.000950s ]
[ SQL ] SELECT * FROM `topic_info_list` WHERE `topic_id` = 1 ORDER BY `id` DESC LIMIT 2 [ RunTime:0.000212s ]
[ SQL ] SELECT * FROM `news` WHERE `id` IN (864,849) [ RunTime:0.000238s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `news` WHERE `review_status` = 1 AND `is_show` = 1 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000254s ]
[ SQL ] SHOW COLUMNS FROM `user` [ RunTime:0.000932s ]
[ SQL ] SELECT `a`.* FROM `user` `a` INNER JOIN `news` `b` ON `a`.`id`=`b`.`user_id` GROUP BY `a`.`id` ORDER BY `b`.`id` DESC LIMIT 10 [ RunTime:0.011493s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (348,351,466,458,209,372,521,819,385,657) [ RunTime:0.000869s ]
[ SQL ] SHOW COLUMNS FROM `seo` [ RunTime:0.001068s ]
[ SQL ] SELECT * FROM `seo` WHERE `column_type` = '02' AND `page_type` = 'news' AND `info_id` = 564 LIMIT 1 [ RunTime:0.000265s ]
[ SQL ] SHOW COLUMNS FROM `tag` [ RunTime:0.000984s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000255s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 564 [ RunTime:0.001708s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000314s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 533 [ RunTime:0.001784s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000194s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 19 [ RunTime:0.001796s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000234s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 817 [ RunTime:0.001729s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7037 [ RunTime:0.001709s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6798 [ RunTime:0.001694s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6775 [ RunTime:0.001670s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6670 [ RunTime:0.001702s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6531 [ RunTime:0.001676s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 5958 [ RunTime:0.001748s ]
[ SQL ] SELECT * FROM `user` WHERE `id` = 1 LIMIT 1 [ RunTime:0.000171s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 348 LIMIT 1 [ RunTime:0.000159s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 348 LIMIT 1 [ RunTime:0.000133s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 351 LIMIT 1 [ RunTime:0.000120s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 351 LIMIT 1 [ RunTime:0.000136s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 466 LIMIT 1 [ RunTime:0.000115s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 466 LIMIT 1 [ RunTime:0.000113s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 458 LIMIT 1 [ RunTime:0.000129s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 458 LIMIT 1 [ RunTime:0.000112s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 209 LIMIT 1 [ RunTime:0.000121s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 209 LIMIT 1 [ RunTime:0.000114s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 372 LIMIT 1 [ RunTime:0.000113s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 372 LIMIT 1 [ RunTime:0.000110s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 521 LIMIT 1 [ RunTime:0.000114s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 521 LIMIT 1 [ RunTime:0.000115s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 819 LIMIT 1 [ RunTime:0.000135s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 819 LIMIT 1 [ RunTime:0.000114s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 385 LIMIT 1 [ RunTime:0.000111s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 385 LIMIT 1 [ RunTime:0.000120s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 657 LIMIT 1 [ RunTime:0.000111s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 657 LIMIT 1 [ RunTime:0.000122s ]

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