Whether A Medical Device Can Use Its Own Clinical Data As The Clinical Data Of Comparable Devices When This Device Is Re-classified?

Yes. Its relevant pre-market and post-market clinical data should be fully collected when it was approved as previous class, and all data need to be summarized and analyzed scientifically. The main concerns are whether the device in question can achieve the expected performance under normal conditions of use; Whether the risks of the device are acceptable compared to its expected benefits; Whether the clinical performance and safety of the device are supported by appropriate evidence.