Clinical Evaluation

1

Supply of Enterprise Qualification, IFU and Test Report

2

Signing of Clinical Agency Service Agreement
3 Draft of Clinical Trial Scheme
4 Selection of Test Center
5 Ethical Review
6 Clinical Trial Review and Approval (if necessary)
7 Signing of Clinical Agreement with Hospital
8 Application for Clinical Filing to Provincial Food and Drug Administration by Applicant
9 Initiation of Clinical Trial
10 Supervision and Follow-up during Clinical Trial
11 Statistics and Data Management
12 Review Conference for Clinical Trial Summary Report
13 Compilation of Clinical Trial Summary Report