Consultation on the IVD reagent inspection guide
NMPA’s Comprehensive Department issued a consultation notice on September 29, 2026, proposing revised GMP inspection guides for IVD reagents and custom-made dentures. The IVD proposal revises the earlier on-site inspection guide issued under 食药监械监〔2015〕218号. It remains a draft, with comments due October 10, 2026.
The IVD draft guides inspections of IVD reagent registrants, filing holders and contract manufacturers. This article focuses on that draft; the denture guide is a separate attachment with its own inspection items.
A combined checklist with three risk levels
The draft integrates the general medical device GMP and the IVD reagent appendix into 212 inspection items: 42 critical items (), 93 major items () and 77 general items (). Each item identifies its underlying GMP or appendix provision. Inspection types and outcome determinations follow the general medical device GMP inspection guide.
For IVD teams, the practical focus is the proposed mapping of general quality-system requirements and reagent-specific controls into one graded checklist. Facilities, process water and biological contamination controls appear together in the facility chapter. Examples of critical items include appropriate supporting facilities (4.7.1), process water meeting product-quality needs (4.7.5), and controlled handling of potentially contaminating, infectious or highly biologically active materials (4.12.1). The latter also covers separation of PCR reagent production and testing spaces to prevent aerosol cross-contamination.
These examples draw on the general GMP and existing IVD appendix. Their inclusion should not be described as making every technical control newly introduced by this consultation. The three levels classify inspection items; the draft refers outcome decisions to the general guide rather than setting out a separate IVD enforcement regime.
Keep the consultation and GMP implementation dates separate
The published general inspection-guide notice states that the revised GMP and general inspection guide take effect on November 1, 2026. From that date, IVD reagent production quality management must comply with the revised GMP and the applicable existing appendix.
The September 29 consultation does not set an effective date for the proposed IVD inspection guide. Its October 10 deadline is the deadline for comments.
What IVD teams can review first
- Map the draft items to existing internal audit checklists, procedures and supporting records, beginning with the proposed critical items.
- Check facility qualification and monitoring, water specifications and maintenance records, and applicable biosafety and PCR separation controls.
- Review quality-management independence, change control and product release; for contract manufacturing, check the allocation of manufacturing release and market release responsibilities.
- Use the IVD feedback form in the notice to submit comments to mdgmp@cfdi.org.cn by October 10, 2026, with the specified IVD feedback subject line.
These are preparation suggestions based on the draft. Companies can use the consultation to identify gaps and practical wording concerns while planning separately for the already established GMP implementation date.
Sources
- Primary official source医疗器械生产质量管理规范体外诊断试剂检查指导原则（征求意见稿） (opens in a new tab)National Medical Products Administration
- Supporting 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体外诊断试剂检查指导原则（征求意见稿）》等意见 (opens in a new tab)National Medical Products Administration
- Supporting source国家药监局关于印发医疗器械生产质量管理规范检查指导原则的通知 (opens in a new tab)Shanghai Municipal Medical Products Administration