IVD Registration
In vitro diagnostic (IVD) reagents are registered under the IVD Registration and Filing Administration Measures (NMPA Order No. 48). The registration pathway mirrors the general device pathway but with IVD-specific dossier requirements.
IVD dossier β key differences from general devicesβ
| Element | General device | IVD |
|---|---|---|
| Clinical evidence | Performance data, clinical evaluation | Clinical performance study (sensitivity, specificity, reference range) |
| Technical requirements | Performance specifications | Analytical and clinical performance specifications |
| Reference materials | Standard curve, calibrators | Reference materials, commutability requirements |
| Stability | Real-time and accelerated stability | Real-time, accelerated, and open-vial stability |
Clinical performance studyβ
For Class II and III IVDs, a clinical performance study at NMPA-recognised clinical trial institutions is typically required. The study must demonstrate:
- Diagnostic sensitivity and specificity against a gold standard reference method
- Reference interval / reference range (where applicable)
- Reproducibility and lot-to-lot variability
Class III IVDs (e.g. HIV, HCV, HBV screening; molecular diagnostics for serious pathogens) require studies at a minimum of 3 clinical trial institutions.
IVD instrumentsβ
IVD analytical instruments (analysers) are classified and registered separately from their reagents. The instrument and reagent may be submitted together or separately. Where submitted separately, the instrument registration dossier must reference performance data generated using the specific reagent.
Filing for Class I IVDsβ
Class I IVDs follow the same filing process as Class I devices, with the additional requirement to include IVD-specific technical requirements and any applicable performance testing data.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.