NMPA CMDE Seeks Public Comments on Two Medical Device Registration Guidance Principles

On September 8, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration officially issued a notice inviting public comments on two draft guidance principles: Registration Review Guidance Principle for Laparoscopic Surgical Systems – Part 6: Software (Draft for Comments) and Registration Review Guidance Principle for Medical Oxygen Chambers (Draft for Comments). The deadline for feedback is October 8, 2026.

These two guidance documents address the registration review requirements for advanced surgical robot software and medical hyperbaric chambers respectively, and deserve close attention from industry stakeholders.

Regarding the Registration Review Guidance for Laparoscopic Surgical Systems – Part 6: Software

This guidance applies to the software studies of multi-port laparoscopic surgical systems, covering human-machine interaction software, surgeon console software, patient cart software, image processing software, safety and reliability software, and specific functional software (e.g., remote control). The core principles emphasize full life‑cycle management, high reliability with risk prioritization, human‑machine interaction friendliness, and auditability of the entire surgical process. From a technical perspective, the guidance sets forth detailed requirements for self‑test and login management, robotic arm information display, dual‑console operation, force presentation and force feedback, tissue recognition and image fusion, safety monitoring and fault alarms, log auditing, cybersecurity, and remote control – with special attention to network latency, data transmission quality, and emergency response plans for remote procedures.

Regarding the Registration Review Guidance for Medical Oxygen Chambers

This guidance applies to manned pressure vessels using air or oxygen as the pressure medium, including medical air‑pressurized oxygen chambers, medical oxygen‑pressurized oxygen chambers, and infant oxygen chambers. Registration unit division should be based on differences in technical principles, structural composition, chamber cross‑sectional shape, and primary materials – for example, different pressure media, different cross‑sections (circular, square, special‑shaped), and different materials (metal vs. transparent materials) should constitute separate units. Product technical requirements must comply with standards such as GB/T 12130 and GB 9706.1, and should address studies on explosion/fire risk control, high‑altitude effects, software cybersecurity, biocompatibility (e.g., oxygen masks), and use stability. In addition, the instructions for use must satisfy both medical device and special equipment regulatory requirements, and clearly specify in‑chamber equipment management and annual inspection provisions.

Both guidance documents are currently in draft form for public comment. We encourage manufacturers, medical institutions, and industry experts to review them thoroughly and submit your feedback via email before October 8.