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 based on their own intended use and risk factors. A Class I reagent may be used with a Class II instrument; the classes are independent. Each component requires separate classification and registration; the classification of one does not automatically determine the classification of the other.
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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IVDs are registered through a separate pathway under the IVD Registration & Filing Administration Measures (NMPA Order No. 48). Class I IVDs may be registered through a streamlined notification process; Class II and III require full registration review by CMDE. If an IVD classification is unclear, manufacturers may request a classification determination from CMDE following the same procedures as for device classification. IVD registration dossiers must include analytical validation, clinical performance studies (for Class II/III), and risk management documentation specific to diagnostic accuracy and clinical consequences of errors.