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28

2022

-

06

2022年上半年超百件产品进入创新/优先审批通道(附名单)

对于企业来说,进入创新医疗器械特别审批程序,意味着产品的上市时间将会大大缩短,同时可以促进医疗器械新技术的推广和应用;另一方面也是企业创新能力的体现,备受投资方关注。


Author:

近年来,医疗器械审评审批制度不断深入改革,为保障医疗器械的安全、有效,鼓励医疗器械的研究与创新,国家药监局于2018年11月2日发布了新修订的《创新医疗器械特别审查程序》,这对医疗器械产业创新发展起到了积极作用。同时,为了保障医疗器械临床使用需求,原国家食品药品监督管理总局2016年10月26日发布了《医疗器械优先审批程序》,这为提升人民群众实现更好的卫生健康水平发挥了巨大作用。

 

对于企业来说,进入创新医疗器械特别审批程序,意味着产品的上市时间将会大大缩短,同时可以促进医疗器械新技术的推广和应用;另一方面也是企业创新能力的体现,备受投资方关注。

 

总体情况

 

据众成数科(JOINCHAIN)统计,2022年上半年,共计55家企业的65件产品进入创新医疗器械特别审批通道,其中36件产品进入国家级创新审批通道,29件产品进入省级创新审批通道;共计30家企业的50件产品进入优先审批通道,其中3件产品进入国家级优先审批通道,47件产品进入省级优先审批通道。(产品清单见附表1)

 

222

数据来源:JOINCHAIN®众成数科

关键词:

医疗器械审评审批
53287

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It was reported on March 19 that CATL is considering a site selection for a US$5 billion battery factory, which will eventually employ as many as 10,000 workers.

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CATL executives reportedly flew to Mexico for a meeting earlier this month. CATL’s new North American plant will produce nickel-manganese-cobalt and lithium iron phosphate batteries to supply Tesla and other automakers, two people familiar with the matter said.

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However, Ningde Times has not responded to this news.

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It is worth noting that last month, Ningde Times said at the media communication meeting about going to the United States to build a factory:

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CATL has a lot of interaction with American customers, including both new forces and traditional car companies. The two sides jointly discussed various possible supply and cooperation plans, as well as the possibility of localized production, but the specific situation needs to consider worker training, The impact of factors such as efficiency and labor unions on quality and cost.

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reported,considering,selection

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