China Medical Device Registration: Class III Surgery Navigation System & Clinical Equivalence Pathway

Firstly, let's discuss the project plan, including its classification and registration pathway. In China, the project is classified as a class III device under the code 01-07-01 Surgery Navigation System, indicating a high level of risk. We plan to register the device through the clinical equivalence pathway, as recommended by NMPA. However, this does not guarantee that we can avoid clinical trials. If we cannot establish full equivalence, we may still need to conduct clinical trials. Equivalence does not mean identical, but rather safe and efficient. Therefore, the burden of establishing equivalence is significant. NMPA has provided two samples for the equivalence pathway: oral implantation navigation and spinal surgery vertebral pedicle screw navigation. If NMPA determines that the evidence is insufficient, they may require clinical trials.