Beijing, China – 08 Sep 2026 – The Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) has released for public comment two draft registration review guidance documents — “Registration Review Guidelines for Laparoscopic Endoscopy Surgery Systems, Part 6: Software” and “Registration Review Guidelines for Medical Oxygen Chambers” — with feedback due by 8 Oct 2026.
Regulatory Milestone
| Item | Detail |
|---|---|
| Issuing Authority | CMDE, NMPA |
| Notice Type | Public consultation on draft registration review guidance |
| Document 1 | Registration Review Guidelines for Laparoscopic Endoscopy Surgery Systems – Part 6: Software (Draft for Comments) |
| Document 2 | Registration Review Guidelines for Medical Oxygen Chambers (Draft for Comments) |
| Policy Basis | NMPA work plan for formulation and revision of medical device registration review guidance |
| Publication Date | 8 Sep 2026 |
| Comment Deadline | 8 Oct 2026 |
| Submission Method | Completed feedback form (Attachment 3) by email, with subject/file naming convention |
Guidance Documents Under Consultation
- Laparoscopic Endoscopy Software (Part 6): The draft addresses the software component of laparoscopic endoscopy surgery systems — in China’s classification, the device category that also covers robot‑assisted minimally invasive surgery systems. As the sixth part of a multi‑part guidance series, it is set to standardize registration review expectations for system software, a critical compliance reference for both domestic surgical‑robot developers and imported platforms seeking NMPA clearance.
- Medical Oxygen Chambers: The draft provides dedicated registration review guidance for hyperbaric oxygen therapy chambers, a device class spanning hospital‑grade multi‑place chambers and smaller monoplace units used in clinical oxygen therapy. Final guidance will give manufacturers a consolidated benchmark for technical documentation, safety and performance review.
Feedback Procedure
- Form Requirement: Comments must be submitted on the official feedback form (Attachment 3); both draft guidance texts are available for download alongside the notice.
- Naming Convention: Email subjects and file names must follow the format “Feedback Organization + 《Guidance Title》 Feedback.”
- Contact – Document 1 (Endoscopy Software): Mr. Zhang Chenguang, tel. 010‑86452649, email zhangcg@cmde.org.cn.
- Contact – Document 2 (Oxygen Chambers): Mr. Liu Xiaoyin and Ms. Wu Jiangyan, tel. 010‑86452634 / 021‑68662198, emails liuxy1@cmde.org.cn and wujy@ydcmdei.org.cn — the Shanghai‑area contact indicating co‑drafting input from a regional evaluation partner.
Market Impact & Outlook
- Surgical Robotics Compliance Roadmap: For developers in China’s fast‑expanding laparoscopic surgical‑robot sector, Part 6 on software will sharpen expectations on software description, versioning, cybersecurity and standalone‑software documentation — reducing registration ambiguity but raising the bar for pre‑submission preparation.
- Hyperbaric Equipment Standardization: A dedicated guidance for medical oxygen chambers signals maturation of that niche market, with clearer review criteria likely to benefit established manufacturers and streamline entries by new applicants.
- One‑Month Comment Window: The 8 Oct deadline gives industry a short, defined window to shape final texts; manufacturers and trade associations with pending or planned registrations in either category should review the drafts promptly, as final guidance will directly frame technical review dossiers.
- Guidance Cadence: The consultation continues the CMDE’s systematic build‑out of device‑category‑specific review guidance under the NMPA’s multi‑year formulation plan, reinforcing a rules‑based, increasingly transparent registration pathway for medical devices in China.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the consultation process, final content of the two guidance documents, and their impact on device registration timelines. Actual outcomes may differ due to risks including revisions between draft and final versions, feedback evaluation, and subsequent NMPA/CMDE policy actions.-China Health Reform Pulse
Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260908165732174.html