Passive medical devices
2021-03-25
Circular of the CMDE on Guidelines for the Registration and Review of Fundus Image-Assisted Diagnostic Software for Diabetic Retinopathy (No. 23 [2022])
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- Time of issue:2022-06-06
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(Summary description)
Circular of the CMDE on Guidelines for the Registration and Review of Fundus Image-Assisted Diagnostic Software for Diabetic Retinopathy (No. 23 [2022])
(Summary description)
- Categories:News
- Author:
- Origin:
- Time of issue:2022-06-06
- Views:0
Information
In order to further standardize the management of the fundus image-assisted diagnosis software for diabetic retinopathy, the CMDE has organized and formulated the "Guiding Principles for the Registration and Review of the Fundus Image-Assisted Diagnosis Software for Diabetic Retinopathy", which is hereby released.
Notice is hereby given.
Annex: Guidelines for the Review of Registration of Fundus Image-Assisted Diagnostic Software for Diabetic Retinopathy (Download)
Click here to get more information: Circular of the Device Review Center of the State Food and Drug Administration on the Issuance of Guidelines for the Registration and Review of Fundus Image-Assisted Diagnostic Software for Diabetic Retinopathy (No. 23 [2022]) (cmde.org.cn)
Center for Medical Device Evaluation
of National Medical Products Administration
June 2, 2022
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