2023年版 VS 2014年版《医疗器械经营质量管理规范》-医疗器械网

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2023年版 VS 2014年版《医疗器械经营质量管理规范》

来源：上海恒跃医疗器械有限公司分类：商机 2023-12-12 17:45:21 19阅读次数

来源：赛柏蓝器械、中物联医疗器械供应链分会

2023年12月7日，国家药监局发布《关于施行医疗器械经营质量管理规范的公告》。为加强医疗器械经营质量管理，规范医疗器械经营行为，促进行业规范发展，保障公众用械安全有效，根据相关法规规章规定，国家药监局修订了《医疗器械经营质量管理规范》，现予发布，自2024年7月1日起施行。

新版《医疗器械经营质量管理规范》与2014版相比，内容变化较大，共十章116条，分别包括总则，质量管理体系建立与改进，职责与制度，人员与培训，设施与设备，采购、收货与验收，入库、贮存与检查，销售、出库与运输，售后服务，附则十章。本文通过对新旧两版文件逐条对比，以期为行业企业提供参考。

以下为对比全文——

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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.*', $join = Array)
[8]未定义数组索引: center
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: goods_list
[8]未定义数组下标: 0
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[2]Declaration of app\common\model\Tag::getAllList($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: center
[8]未定义数组索引: wtt_list

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[ SQL ] SHOW COLUMNS FROM `news_category` [ RunTime:0.000990s ]
[ SQL ] SELECT `id`,`name` FROM `news_category` WHERE `is_show` = 1 [ RunTime:0.000410s ]
[ SQL ] SELECT * FROM `news_category` WHERE `parent_id` = 0 AND `is_show` = 1 ORDER BY `sort` ASC,`id` DESC [ RunTime:0.000198s ]
[ SQL ] SHOW COLUMNS FROM `company` [ RunTime:0.000956s ]
[ SQL ] SHOW COLUMNS FROM `news` [ RunTime:0.000986s ]
[ SQL ] SELECT * FROM `news` WHERE `md5` = 'bd56c234c733fbe3' AND `review_status` = 1 LIMIT 1 [ RunTime:0.000324s ]
[ SQL ] SHOW COLUMNS FROM `user_info` [ RunTime:0.000989s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` = 7 [ RunTime:0.000871s ]
[ SQL ] SELECT * FROM `company` WHERE `id` = 33 [ RunTime:0.000273s ]
[ SQL ] SHOW COLUMNS FROM `news_text` [ RunTime:0.000855s ]
[ SQL ] SELECT * FROM `news_text` WHERE `news_id` = 3334 [ RunTime:0.027487s ]
[ SQL ] SHOW COLUMNS FROM `news_belong_category` [ RunTime:0.000965s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3334 [ RunTime:0.002817s ]
[ SQL ] SELECT * FROM `news_category` WHERE `id` IN (10) [ RunTime:0.000249s ]
[ SQL ] SHOW COLUMNS FROM `user_follow` [ RunTime:0.000933s ]
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[ SQL ] SHOW COLUMNS FROM `news_comment` [ RunTime:0.000861s ]
[ SQL ] SELECT * FROM `news_comment` WHERE `news_id` = 3334 AND `parent_id` = 0 ORDER BY `id` DESC [ RunTime:0.000236s ]
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[ SQL ] SELECT * FROM `news` WHERE `is_show` = 1 AND `review_status` = 1 AND `id` IN (3334,564,533,19,817,7037,6798,6775,6670,6531) ORDER BY field(id,3334,564,533,19,817,7037,6798,6775,6670,6531) [ RunTime:0.000363s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (7,1,172,12,13,503,293) [ RunTime:0.000779s ]
[ SQL ] SHOW COLUMNS FROM `topic` [ RunTime:0.000836s ]
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[ SQL ] SHOW COLUMNS FROM `topic_info_list` [ RunTime:0.000751s ]
[ SQL ] SELECT * FROM `topic_info_list` WHERE `topic_id` = 1 ORDER BY `id` DESC LIMIT 2 [ RunTime:0.000167s ]
[ SQL ] SELECT * FROM `news` WHERE `id` IN (864,849) [ RunTime:0.000166s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `news` WHERE `review_status` = 1 AND `is_show` = 1 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000202s ]
[ SQL ] SHOW COLUMNS FROM `user` [ RunTime:0.000769s ]
[ 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:0.010321s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (466,458,209,372,521,819,385,657,412,274) [ RunTime:0.000851s ]
[ SQL ] SHOW COLUMNS FROM `seo` [ RunTime:0.000827s ]
[ SQL ] SELECT * FROM `seo` WHERE `column_type` = '02' AND `page_type` = 'news' AND `info_id` = 3334 LIMIT 1 [ RunTime:0.000178s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3334 [ RunTime:0.001824s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 564 [ RunTime:0.001674s ]
[ SQL ] SHOW COLUMNS FROM `tag` [ RunTime:0.000874s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000210s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 533 [ RunTime:0.001547s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000325s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 19 [ RunTime:0.001654s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '医疗器械' LIMIT 1 [ RunTime:0.000174s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 817 [ RunTime:0.001517s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7037 [ RunTime:0.001479s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6798 [ RunTime:0.001474s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6775 [ RunTime:0.001475s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6670 [ RunTime:0.001872s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 6531 [ RunTime:0.001587s ]
[ SQL ] SELECT * FROM `user` WHERE `id` = 7 LIMIT 1 [ RunTime:0.000173s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 466 LIMIT 1 [ RunTime:0.000162s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 466 LIMIT 1 [ RunTime:0.000128s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 458 LIMIT 1 [ RunTime:0.000120s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 458 LIMIT 1 [ RunTime:0.000114s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 209 LIMIT 1 [ RunTime:0.000114s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 209 LIMIT 1 [ RunTime:0.000111s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 372 LIMIT 1 [ RunTime:0.000112s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 372 LIMIT 1 [ RunTime:0.000124s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 521 LIMIT 1 [ RunTime:0.000113s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 521 LIMIT 1 [ RunTime:0.000125s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 819 LIMIT 1 [ RunTime:0.000113s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 819 LIMIT 1 [ RunTime:0.000111s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 385 LIMIT 1 [ RunTime:0.000110s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 385 LIMIT 1 [ RunTime:0.000111s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 657 LIMIT 1 [ RunTime:0.000116s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 657 LIMIT 1 [ RunTime:0.000125s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 412 LIMIT 1 [ RunTime:0.000115s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 412 LIMIT 1 [ RunTime:0.000110s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 274 LIMIT 1 [ RunTime:0.000137s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 274 LIMIT 1 [ RunTime:0.000115s ]

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