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Announcement of NMPA and the National Health Commission on the Quality Management Of Clinical Trials for Medical Devices (No. 28, 2022)

Announcement of NMPA and the National Health Commission on the Quality Management Of Clinical Trials for Medical Devices (No. 28, 2022)

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  • Time of issue:2022-04-07
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(Summary description)

Announcement of NMPA and the National Health Commission on the Quality Management Of Clinical Trials for Medical Devices (No. 28, 2022)

(Summary description)

  • Categories:News
  • Author:
  • Origin:
  • Time of issue:2022-04-07
  • Views:0
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To deepen the reform of the medical device review and approval system and strengthen the management of clinical trials of medical devices, in accordance with the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), the Administrative Measures for the Registration and Filing of Medical Devices (Order No. 47 of the State Administration for Market Regulation), and the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 of the State Administration for Market Regulation), NMPA, together with the National Health Commission, has revised the Quality Management Of Clinical Trials for Medical Devices (No. 28, 2022), which is hereby promulgated. Effective as of May 1, 2022.
This is hereby announced.国家药监局 国家卫生健康委关于发布《医疗器械临床试验质量管理规范》的公告(2022年第28号) (nmpa.gov.cn)

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