Beijing, China – 11 Sep 2026 – The Center for Medical Device Evaluation (CMDE), the technical review arm of China’s National Medical Products Administration (NMPA), announced an open public consultation on the “Guidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment),” with stakeholder feedback due by 9 October 2026.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | CMDE, under NMPA (China) |
| Action Type | Open public consultation on draft registration review guidance |
| Document | Guidance on the Registration Review of Service Life for Active Medical Devices (Revised Edition 2026) (Draft for Public Comment) |
| Issuance Date | 11 Sep 2026 (published online 14 Sep 2026) |
| Comment Deadline | 9 Oct 2026, via email using the official feedback form |
| Contacts | Zheng Chen / Zhu Yu — +86‑10‑86452606; +86‑10‑86452851 — zhengchen@cmde.org.cn; zhuyu@cmde.org.cn |
| Next Steps | CMDE to review submitted comments and finalize the 2026 revised guidance |
Guidance Profile & Regulatory Background
- Revision Mandate: The revision was organized by CMDE in accordance with the NMPA’s standing program for the development and amendment of medical device registration review guidance documents, part of a broader, continuous modernization of China’s MedTech technical review framework.
- Scope: The guidance governs how service life (use period) claims for active medical devices — devices that rely on electrical or other energy sources for operation — should be substantiated and evaluated during registration review in China.
- Consultation Materials: Two attachments accompany the notice: the draft revised guidance (Attachment 1) and a standardized feedback form (Attachment 2), both downloadable from CMDE’s website.
- Submission Channel: Comments and suggestions must be completed on the feedback form and emailed to the designated CMDE contacts before the 9 October 2026 deadline.
- Source: cmde.org.cn official notice
Market Impact & Outlook
- Compliance Relevance: Service life substantiation is a core component of registration dossiers for active medical devices in China; manufacturers, contract research organizations, and testing institutions should review the draft early and assess potential impacts on existing and planned registration strategies.
- Industry Participation Window: Stakeholders have approximately four weeks to submit structured feedback — an opportunity for domestic and foreign MedTech companies to help shape review expectations before the guidance is finalized.
- Regulatory Trajectory: The 2026 revision continues NMPA’s pattern of periodically updating technical review guidance to reflect evolving device technologies and international standards; the final version and its effective date have not yet been disclosed.
- Pipeline Implications: Once finalized, the revised guidance will apply to new registration submissions for active medical devices and may influence how legacy service life claims are maintained or amended in post‑market regulatory activities.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, the finalization of the draft guidance, and its potential impact on medical device registration in China. Actual outcomes may differ due to risks including changes arising from the public consultation process, final agency determinations, and shifts in regulatory policy.-China Health Reform Pulse
Policy Source: https://www.cmde.org.cn/flfg/zdyz/zqyjg/20260914132853156.html