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Circular of The Instrument Review Center of the State Food and Drug Administration on The Issuance of The Guiding Principles for The Registration and Review of Medical Device Software (Revised version in 2022) (No. 9, 2022)

Circular of The Instrument Review Center of the State Food and Drug Administration on The Issuance of The Guiding Principles for The Registration and Review of Medical Device Software (Revised version in 2022) (No. 9, 2022)

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  • Time of issue:2022-03-15
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Circular of The Instrument Review Center of the State Food and Drug Administration on The Issuance of The Guiding Principles for The Registration and Review of Medical Device Software (Revised version in 2022) (No. 9, 2022)

(Summary description)

  • Categories:News
  • Author:
  • Origin:
  • Time of issue:2022-03-15
  • Views:0
Information

In order to further standardize the management of medical device software, the Instrument Review Center of sFDA has organized and formulated the Guiding Principles for The Examination of Medical Device Software Registration (Revised version 2022), which is hereby published.  

We hereby inform you.  

Appendix: Medical Device Software Registration Review Guidelines (Revised version 2022) (Download)  

国家药监局器审中心关于发布医疗器械软件注册审查指导原则(2022年修订版)的通告(2022年第9号) (cmde.org.cn)

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