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NMPA Announcement on Issuing of Two Registration Technical Review Guidelines Including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products

CCFDIE|Updated: 2021-01-18

In order to strengthen the supervision and guidance over medical device registration and further improve the quality of registration review, the NMPA has organized to formulate 2 technical review guidelines for registration including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products, which are hereby promulgated on January 15, 2021.