- After The ERPS System Is Launched, How Can I Submit Supplementary Materials For Registration And Declaration Through Online Channels?
- After The ERPS System Is Launched, How Can I Submit Supplementary Materials For Review And Registration Through Online Channels?
- After The ERPS System Is Launched, How Can I Submit Supplementary Materials For Review And Registration Through Offline Channels?
- Does The Approval Of The Clinical Trial Application Also Approve The Clinical Trial Plan?
- How To Add Page Numbers To Documents In ERPS System?
- Whether A Similar Device Can Be Chosen As A Control Product In A Parallel Controlled Clinical Trial?
- When Calculating The Sample Size Of Diagnostic Devices In Clinical Trials, Can We Refer To “Guidelines For Design Of Clinical Trials Of Medical Devices”?
- Can The Applicant Choose A Typical Model Of Devices To Conduct A Clinical Trial If There Are Multiple Models In One Registry Unit?
- Whether Overseas Clinical Trial Data Only Can Be Accepted When Chinese Subjects Were Enrolled?
- Whether Medical Devices Listed In “The Catalog Of Class III Medical Devices That Needs Approval For Clinical Trial Conduction” Must Conduct Clinical Trials In China?
- Whether The Overseas Clinical Trial Data Must Meet The Requirements Of The Chinese Guidelines Of Specific Products?
- Whether All The Comparing Items Listed In The “Guidelines For Clinical Evaluation Of Medical Devices” Need To Be Done When Conducting Clinical Evaluation By The Method Of Using Comparable Device(s)?