What is an IVD?
In vitro diagnostic reagents (δ½ε€θ―ζθ―ε) are a distinct sub-category of medical devices under Chinese law. They include reagents, calibration materials, quality control materials, kits, instruments, and related systems used to collect, prepare, and examine specimens taken from the human body for the purpose of providing information for disease diagnosis, prevention, or treatment.
IVDs are regulated under the same MDSAR 2021 framework as other medical devices, but with a separate implementing measure β the In Vitro Diagnostic Reagent Registration and Filing Administration Measures (NMPA Order No. 48) β and distinct classification rules.
IVD Classificationβ
IVDs are classified into Class I, II, or III using the IVD Classification Rules in the NMPA Catalogue. Risk is determined primarily by:
- The intended use (diagnosis of life-threatening conditions = higher risk)
- Whether the result directly determines treatment decisions
- Whether there is an established reference method
See Classification Rules for IVDs for full detail.
Key IVD-specific obligationsβ
- Class I IVDs: filing (ε€ζ‘) with local authority, no clinical performance study required in most cases
- Class II/III IVDs: registration (注ε) with provincial or national NMPA, clinical performance study or literature evidence required
- All registered IVDs: must be listed in the NMPA Medical Device Registration Database
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