Medical deivce consulting company

Summary of medical device technical review work in July 2023

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.