CFDA issued two guidelines for technical review of registrations  

In order to strengthen the supervision and guidance of the registration of medical device products of vision screening instrument and mammography system, the State Food and Drug Administration (CFDA) on June 29 officially issued the “Guides for the Technical Examination of the Registration of Vision Screening Instrument” and “Guides for the Technical Examination of the Registration of mammography System”, aiming to further improve the quality of the registration examination(See attachment).

Attachment:

1. Guiding principles for technical review of visual screening device registration
2. Guidelines for Technical Review of mammographySystem Registration

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210629161924195.html

For the Englishi version of two guidelines, please contact info@inspirativemed.com