Guidelines for Registration Review of Laparoscopic Surgery Systems Part 5: Systems and Software

On April 22^nd ,2024, China CMDE has started the preparation of “Guidelines for Registration Review of Laparoscopic Surgery Systems Part 5: Systems and Software”. Based on the published “Key Points for Technical Review of Laparoscopic Surgery Systems (2023 Revised Edition)”, refine and improve the relevant requirements for the system and software parts (excluding end effectors) and formulate guidelines. CMDE called public comments before May 17^th .