What changed
On September 23, 2026, NMPA’s Comprehensive Department issued a public notice seeking comments on revised inspection guides for sterile medical devices and implantable medical devices. The notice was published on September 24 and invites comments through October 8, 2026.
The drafts revise the previous on-site inspection guides and combine the general Good Manufacturing Practice for Medical Devices with the relevant sterile-device or implantable-device appendix to form inspection items. The revised general GMP takes effect on November 1, 2026.
The drafts classify inspection items by risk level
The sterile-device draft contains 216 inspection items: 41 critical, 95 major, and 80 general. The implantable-device draft contains 220: 42 critical, 98 major, and 80 general.
Examples identified as critical in the drafts include separating the heads of production management and quality management, and giving the quality department independent quality-assurance and quality-control authority. For implantable devices, examples include linking production and sterilization batch numbers, maintaining traceable production records for each batch or unit, and validating processes for inactivating or removing viruses and other infectious pathogens when biological safety is involved.
Inspection types and outcome determinations follow the general Medical Device Good Manufacturing Practice Inspection Guide. The drafts therefore provide a more concrete risk-level structure for translating the revised GMP and its special appendices into inspection practice.
What companies can check
- Compare existing sterile-device or implantable-device audit checklists with the corresponding draft inspection items.
- Prioritize the draft’s critical items in internal review, including quality-management independence, batch traceability, sterilization, and validated biological-safety processes where applicable.
- Map internal findings to critical, major, and general categories to identify potential inspection-readiness gaps.
- Check that procedures, records, training, and internal audit tools can support the revised GMP and applicable appendices by November 1, 2026.
- Consider submitting comments on the draft wording or classification before October 8, 2026.
These are MedTech Current’s preparation suggestions based on the consultation drafts; the inspection guides remain drafts, and the proposed item structure should not be treated as final.
Sources
- Primary official source国家药监局综合司公开征求《医疗器械生产质量管理规范无菌医疗器械检查指导原则（征求意见稿）》等意见 (opens in a new tab)National Medical Products Administration
- Supporting sourceAnnouncement of the National Medical Products Administration on the Release of the Good Manufacturing Practice for Medical Devices ([2025] No. 107) (opens in a new tab)National Medical Products Administration