The CMDE implements the decisions and deployments of the Party Central Committee, the State Council and the bureau’s party group, and conducts technical review, pre-review of supplementary materials, medical device technical consultation, approval of some administrative approval items, registration certificate number and data circulation, etc. in accordance with functions and procedures. various tasks.
Status of registration application
There were 1,161 various application items that were transferred into the technical review process, and 1,169 items were transferred out of the review process.
Registration application accepted
File review of 1488 items
Accepted 2181 registration applications
Change record 1112 items
196 first-class filings for import
Supplementary information
CMED issued 616 supplementary data notices and received 489 supplementary data.
Expert Advisory Meetings
Started 5 expert consultations and organized 3 expert consultation meetings.
Registration quality management system verification
Started 250 registration quality management system inspections and received 300 inspection results
Special Review for Innovative Medical Devices
Received 47 innovation applications, organized 32 expert review meetings, and completed 38 reviews
Priority approval for medical device review
Received 0 applications for priority review and completed 0 applications.