Passive medical devices
2021-03-25
Promotion of the Reform of Medical Device Review and Approval System -- An exclusive interview with Sun Lei, director of Medical Device Technical Review Center of SFDA
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- Time of issue:2022-05-12
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(Summary description)
Promotion of the Reform of Medical Device Review and Approval System -- An exclusive interview with Sun Lei, director of Medical Device Technical Review Center of SFDA
(Summary description)
- Categories:News
- Author:
- Origin:
- Time of issue:2022-05-12
- Views:0
Information
In recent years, the reform of medical device review and approval system has been advanced, which requires the establishment of a more scientific and efficient medical device review and approval system. The Center for Medical Device Evaluation of NMPA(hereinafter referred to as the Device Review Center) carefully plans, establishes rules and regulations, makes solid progress, optimizes the review process, standardizes the review work, implements the review science, and continuously improves the quality and efficiency of the review. In 2021, a total of 35 innovative medical devices were reviewed, a record number. In addition, the service is also in the evaluation, carrying out a large number of public welfare training, for the registration of applicants to clear up doubts, speed up the market of medical devices to meet clinical needs.
Recently, Sun Lei, director of the Device Review Center, answered questions from China Medical News reporters on the topic of "how to continue to deepen the reform of medical device review and approval system".
Click here to get more information.推动医疗器械审评审批制度改革向纵深发力——专访国家药监局医疗器械技术审评中心主任孙磊 (cmde.org.cn)
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