Classification Rules for IVDs
In vitro diagnostic (IVD) reagents are classified under a separate section of the NMDCC using risk criteria specific to diagnostics.
IVD classification criteria
IVD risk is assessed against four factors:
- Intended use population and clinical setting — point-of-care, self-test, or laboratory use; for screening or confirmation
- Disease severity — is the IVD used to diagnose a life-threatening or infectious condition?
- Consequence of an incorrect result — does an error directly determine a treatment decision?
- Availability of reference methods — can results be verified by an established reference standard?
IVD classes (典型示例)
| Class | Typical IVDs |
|---|---|
| Class I | General chemistry reagents with low clinical risk; non-clinical IVDs |
| Class II | Biochemistry reagents for common conditions (glucose, cholesterol); some immunoassay reagents |
| Class III | HIV, HBV, HCV screening; blood group typing; tumour markers used for treatment decisions; molecular diagnostic reagents for serious infections |
IVD instruments
IVD analysers and instruments are classified separately from reagents. A Class I reagent may be used on a Class II instrument. Classification of the instrument does not determine the class of the reagent, and vice versa.
Key reference
The IVD classification catalogue is published as part of the NMDCC. The IVD Registration & Filing Administration Measures (NMPA Order No. 48) sets out the registration pathway for each IVD class.
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