NMPA Releases New Guidance on Patient Model Testing for Surgical Robotic Systems: Part 5 of the Registration Review Guidelines Officially Issued

On September 28, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) officially issued the "Guidance Principles for Registration Review of Laparoscopic Endoscopic Surgical Systems – Part 5: Patient Model Experimental Research" (Announcement No. 26 of 2026). The guidance aims to further standardize the registration and management of laparoscopic endoscopic surgical systems, providing technical references for applicants conducting patient model testing for product performance research, as well as review references for evaluation authorities assessing related submissions.

The release of this guidance marks a critical step forward in China's surgical robotics review framework regarding in vitro simulation validation. The guidance applies to multi-port laparoscopic endoscopic surgical systems during product design and verification phases, with single-port systems able to reference applicable sections. Its core positioning is to establish patient model testing as an important supplement to animal testing, leveraging the advantages of patient models in anatomical structure replication, mechanical property quantification, and standardized repeatable testing to more comprehensively verify product controllability, efficacy, and safety.

Notably, the guidance provides clear encouraging directives for change registration and product iteration scenarios. When key components along the master-slave control path change, surgical instrument structures or types are modified, new clinical procedures are added to the scope of application, or robotic arm positions or quantities change leading to altered surgical positioning, patient model testing is encouraged to evaluate product safety and efficacy. This requirement aligns closely with the rapid iteration characteristics of the surgical robotics industry in recent years, offering a clear compliance pathway for enterprises in product lifecycle management.

At the experimental design level, the guidance proposes several operational technical requirements. For test samples, instruments within the same category should select the model with the most complex structure, highest degrees of freedom, largest end-effector pose space, and lowest motion precision as the worst-case scenario for validation. For patient models, applicants must fully justify model suitability and submit supporting data based on human imaging, mechanical measurements, or literature values. A minimum of three groups is generally recommended, with surgical procedures covering typical procedures in urology, gynecology, general surgery, thoracic surgery, and cardiac surgery within the intended scope. Evaluation metrics include controllability, imaging quality, operative time, surgical outcomes, and system failure frequency, with emphasis on objective quantitative evaluation through sensor data such as motion trajectories and interaction forces.

From an industry impact perspective, this guidance fills the gap between traditional cadaveric dissection and live animal testing regarding tissue mechanics quantification and standardized repeatable testing. For high-risk surgical devices registered as Class II or III medical devices, the review focus increasingly centers on end-effector precision, master-slave coordination latency, and intraoperative collision or tissue overload risks. Patient model testing can precisely isolate animal individual variability interference in device controllability evaluation through standardized test scenarios. Companies preparing submissions should pay particular attention to the adequacy of model suitability evidence and the comparability of objective quantitative metrics.