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?

Medical devices listed in the “The Catalog of Class III Medical Devices that Needs Approval for Clinical Trial Conduction” also can submit overseas clinical trial data in accordance with the requirements in “Guidelines for the Acceptance of Data from Overseas Clinical Trials of Medical Devices”. If the overseas clinical trial data is scientific, complete, sufficient and conforms to the requirements of Chinese regulatory based on ethical principles, legal principles, and scientific principles, no more clinical trials will require to conduct in China.