搜索

国家药监局明确医疗器械注册审批操作规范

作者：管理员
文章来源：管理员
点击次数：863
更新日期：2021-11-08

[摘要]

11月4日，国家药品监督管理局发布《境内第三类和进口医疗器械注册审批操作规范》和《境内第二类医疗器械注册审批操作规范》（以下统称《规范》），两个文件自发布之日起施行。

境内、进口第二类、第三类医疗器械（包括体外诊断试剂）注册审批（指产品注册、变更注册和延续注册）包括受理、技术审评、行政审批和批件制作四个环节。

《规范》明确，境内第三类和进口第二类、第三类医疗器械产品注册的受理和技术审评，变更注册、延续注册、临床试验审批项目的受理、技术审评和行政审批，以及变更备案资料由国家药品监督管理局医疗器械技术审评中心负责接收。境内第三类和进口第二类、三类医疗器械产品注册的行政审批由国家药监局负责，批件（文件）制作由国家药监局行政事项受理服务和投诉举报中心负责。

《规范》对受理、技术审评和行政审批工作的流程及相关要求等也作出了明确规定。《规范》指出，境内第三类和进口医疗器械注册申请人可通过医疗器械注册电子申报信息化系统申报，无需提交纸质资料，申请资料应当符合相应医疗器械注册申请电子提交技术指南要求；提交纸质资料的应当与相应医疗器械注册申请电子提交技术指南规定的电子申报目录形式一致，同时需提交相应资料电子文档。

《规范》明确，技术审评环节包括主审、复核、签发三个程序。技术审评机构对境内第二类医疗器械安全性、有效性、质量可控性研究和结果进行系统评价，提出结论性意见，并对技术审评阶段出具的审评意见负责。

同时，《规范》在延续注册方面明确，国家药监局应当在《医疗器械注册证》有效期届满前作出准予延续的决定；逾期未作决定的，视为准予延续。但省级药品监督管理部门发出补正资料通知和召开专家会议通知等行为，不属于逾期未作决定的情形。

对于延续注册和原注册证变更的衔接，《规范》指出，企业对原注册证申请变更注册或者办理变更备案，医疗器械变更注册（备案）文件登载的注册证编号为原注册证编号。如企业同时又对原注册证申请延续注册，延续注册需核发新的注册证编号。在这种情况下，企业可在延续注册证备注栏中载明原注册证编号。相应产品医疗器械变更注册（备案）文件无论批准时间，均可以与延续注册批准的注册证共同使用。

上一篇：国家药监局通知进一步明确普通化妆品备案管理工作有关事项

下一篇：质量安全负责人能否在不同企业兼任？药监局六问六答

基本文件流程错误 SQL 调试

/usr/home/qxu2060290349/htdocs/index.php ( 0.42 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/start.php ( 0.71 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/base.php ( 2.60 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Loader.php ( 18.92 KB )
/usr/home/qxu2060290349/htdocs/vendor/composer/autoload_namespaces.php ( 0.15 KB )
/usr/home/qxu2060290349/htdocs/vendor/composer/autoload_psr4.php ( 0.39 KB )
/usr/home/qxu2060290349/htdocs/vendor/composer/autoload_classmap.php ( 0.14 KB )
/usr/home/qxu2060290349/htdocs/vendor/composer/autoload_files.php ( 0.24 KB )
/usr/home/qxu2060290349/htdocs/vendor/topthink/think-captcha/src/helper.php ( 1.59 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Route.php ( 57.98 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Config.php ( 5.86 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Validate.php ( 38.53 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Error.php ( 3.47 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/convention.php ( 9.97 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/App.php ( 19.88 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Request.php ( 47.48 KB )
/usr/home/qxu2060290349/htdocs/application/config.php ( 9.34 KB )
/usr/home/qxu2060290349/htdocs/application/database.php ( 1.96 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Hook.php ( 4.63 KB )
/usr/home/qxu2060290349/htdocs/application/tags.php ( 1.02 KB )
/usr/home/qxu2060290349/htdocs/application/common.php ( 0.60 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Env.php ( 1.05 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/helper.php ( 17.22 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Lang.php ( 6.72 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Cookie.php ( 6.67 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Log.php ( 5.51 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/lang/zh-cn.php ( 3.78 KB )
/usr/home/qxu2060290349/htdocs/application/route.php ( 3.87 KB )
/usr/home/qxu2060290349/htdocs/application/index/config.php ( 0.44 KB )
/usr/home/qxu2060290349/htdocs/application/index/common.php ( 1.59 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Debug.php ( 6.80 KB )
/usr/home/qxu2060290349/htdocs/application/common/behavior/SetTheme.php ( 1.23 KB )
/usr/home/qxu2060290349/htdocs/application/index/controller/News.php ( 4.62 KB )
/usr/home/qxu2060290349/htdocs/application/index/controller/Base.php ( 2.54 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Controller.php ( 5.99 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/traits/controller/Jump.php ( 4.82 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/View.php ( 6.63 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/view/driver/Think.php ( 5.45 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Template.php ( 45.36 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/template/driver/File.php ( 2.17 KB )
/usr/home/qxu2060290349/htdocs/application/index/lang/cn.php ( 6.51 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Field.php ( 0.08 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Model.php ( 57.31 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Db.php ( 6.28 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/db/connector/Mysql.php ( 4.37 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/db/Connection.php ( 28.17 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/db/Query.php ( 85.76 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/db/builder/Mysql.php ( 1.98 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/db/Builder.php ( 28.75 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Siteinfo.php ( 0.08 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Category.php ( 2.58 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Navigation.php ( 1.19 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/News.php ( 1.97 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Cache.php ( 6.13 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/cache/driver/File.php ( 6.73 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/cache/Driver.php ( 5.24 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Sort.php ( 0.93 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Ad.php ( 0.08 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/AttributeValue.php ( 0.48 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Url.php ( 12.40 KB )
/usr/home/qxu2060290349/htdocs/application/index/controller/Replace.php ( 1.72 KB )
/usr/home/qxu2060290349/htdocs/application/index/model/Module.php ( 0.08 KB )
/usr/home/qxu2060290349/htdocs/runtime/temp/76d8aec74d77e0e69fa63681a1f62947.php ( 16.78 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/Response.php ( 8.10 KB )
/usr/home/qxu2060290349/htdocs/thinkphp/library/think/debug/Html.php ( 4.16 KB )

[ DB ] CONNECT:[ UseTime:0.005017s ] mysql:dbname=qdm791091252_db;host=qdm791091252.my3w.com;charset=utf8
[ SQL ] SHOW COLUMNS FROM `bmkj_field` [ RunTime:0.002613s ]
[ SQL ] SELECT * FROM `bmkj_field` WHERE `lang` = 'cn' [ RunTime:0.002270s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_siteinfo` [ RunTime:0.002603s ]
[ SQL ] SELECT * FROM `bmkj_siteinfo` WHERE `lang` = 'cn' LIMIT 1 [ RunTime:0.002296s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_sort` [ RunTime:0.002660s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 0 AND `moduleid` = 1 AND `lang` = 'cn' ORDER BY sequence desc LIMIT 3 [ RunTime:0.002392s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_project` [ RunTime:0.002600s ]
[ SQL ] SELECT * FROM `bmkj_project` WHERE `lang` = 'cn' [ RunTime:0.002318s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_news` [ RunTime:0.002723s ]
[ SQL ] SELECT * FROM `bmkj_news` WHERE `lang` = 'cn' AND (`status` LIKE '%view%' AND `status` LIKE '%hot%') ORDER BY sequence asc LIMIT 10 [ RunTime:0.017826s ]
[ SQL ] SELECT `news`.*,sort.title as category_title FROM `bmkj_news` `news` INNER JOIN `bmkj_sort` `sort` ON `news`.`sortid`=`sort`.`id` WHERE `news`.`lang` = 'cn' ORDER BY `news`.`sequence` desc LIMIT 10 [ RunTime:0.007726s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_ad` [ RunTime:0.002893s ]
[ SQL ] SELECT * FROM `bmkj_ad` WHERE `lang` = 'cn' [ RunTime:0.002260s ]
[ SQL ] SELECT * FROM `bmkj_ad` WHERE `lang` = 'cn' AND `position` = 'down' [ RunTime:0.002245s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_navigation` [ RunTime:0.002652s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 0 AND `lang` = 'cn' ORDER BY sequence desc,id desc [ RunTime:0.002534s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 54 ORDER BY sequence desc,id desc [ RunTime:0.002433s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 59 ORDER BY sequence desc,id desc [ RunTime:0.002473s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 55 ORDER BY sequence desc,id desc [ RunTime:0.002225s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 121 ORDER BY sequence desc,id desc [ RunTime:0.002713s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 122 ORDER BY sequence desc,id desc [ RunTime:0.002208s ]
[ SQL ] SELECT * FROM `bmkj_navigation` WHERE `parentid` = 56 ORDER BY sequence desc,id desc [ RunTime:0.002254s ]
[ SQL ] SELECT * FROM `bmkj_news` WHERE `id` = 658 LIMIT 1 [ RunTime:0.002722s ]
[ SQL ] UPDATE `bmkj_news` SET `hits`=hits+1 WHERE `id` = 658 [ RunTime:0.002500s ]
[ SQL ] SELECT * FROM `bmkj_sort` [ RunTime:0.002358s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `lang` = 'cn' AND `moduleid` = 2 [ RunTime:0.002304s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `moduleid` = 2 AND `parentid` = 0 AND `lang` = 'cn' ORDER BY sequence desc,id desc [ RunTime:0.002282s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 123 ORDER BY sequence desc,id desc [ RunTime:0.002240s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 124 ORDER BY sequence desc,id desc [ RunTime:0.002282s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 125 ORDER BY sequence desc,id desc [ RunTime:0.002460s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 194 ORDER BY sequence desc,id desc [ RunTime:0.002999s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 196 ORDER BY sequence desc,id desc [ RunTime:0.002496s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `parentid` = 195 ORDER BY sequence desc,id desc [ RunTime:0.002328s ]
[ SQL ] SELECT * FROM `bmkj_ad` WHERE `position` = 'news' AND `typeid` = 1 AND `lang` = 'cn' LIMIT 1 [ RunTime:0.002277s ]
[ SQL ] SELECT * FROM `bmkj_sort` WHERE `id` = 124 LIMIT 1 [ RunTime:0.002202s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_attribute_value` [ RunTime:0.002747s ]
[ SQL ] SELECT `attribute_value`.`id`,`attribute_value`.`attvalue`,`attribute`.`attname` FROM `bmkj_attribute_value` `attribute_value` INNER JOIN `bmkj_attribute` `attribute` ON `attribute`.`id`=`attribute_value`.`attid` WHERE `attribute_value`.`moduleid` = 2 AND `attribute_value`.`infoid` = '658' ORDER BY `sequence` desc,`attribute_value`.`id` desc [ RunTime:0.002322s ]
[ SQL ] SELECT * FROM `bmkj_news` WHERE `id` < 658 AND `lang` = 'cn' AND `sortid` IN (124) ORDER BY sequence desc,id desc LIMIT 1 [ RunTime:0.005601s ]
[ SQL ] SELECT * FROM `bmkj_news` WHERE `id` > 658 AND `lang` = 'cn' AND `sortid` IN (124) ORDER BY sequence asc,id asc LIMIT 1 [ RunTime:0.003975s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_module` [ RunTime:0.002718s ]
[ SQL ] SELECT * FROM `bmkj_module` WHERE `id` = 2 LIMIT 1 [ RunTime:0.002251s ]
[ DB ] CONNECT:[ UseTime:0.004109s ] mysql:dbname=qdm791091252_db;host=qdm791091252.my3w.com;charset=utf8
[ SQL ] SHOW COLUMNS FROM `bmkj_language` [ RunTime:0.002380s ]
[ SQL ] SELECT * FROM `bmkj_language` WHERE ( status=1 ) ORDER BY sequence asc LIMIT 5 [ RunTime:0.001890s ]
[ SQL ] SHOW COLUMNS FROM `bmkj_keywordlink` [ RunTime:0.002597s ]
[ SQL ] SELECT * FROM `bmkj_keywordlink` WHERE ( linkurl<>'' ) ORDER BY sequence desc LIMIT 2000 [ RunTime:0.002227s ]
[ DB ] CONNECT:[ UseTime:0.004067s ] mysql:dbname=qdm791091252_db;host=qdm791091252.my3w.com;charset=utf8
[ SQL ] SHOW COLUMNS FROM `bmkj_chat` [ RunTime:0.002528s ]
[ SQL ] SELECT * FROM `bmkj_chat` WHERE ( lang='cn' and typeid='qq' ) ORDER BY sequence desc,id desc LIMIT 5 [ RunTime:0.002267s ]

搜索

搜索

热门文章

国家药监局明确医疗器械注册审批操作规范