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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

2021-02-04 15:10:23 147

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.

 

Click the link below to download Chinese guildlines

医用磁共振成像系统同品种临床评价技术审查指导原则(2020年修订版)(2021年第12号)

国家药品监督管理局2021年第12号通告附件.doc