Unlike the “Medical Device Classification Rules”, the NMPA did not separately regulate the classification of IVD reagents before. Instead, the guidelines were written into the “Notice on Issuing the Registration Management Measures for In Vitro Diagnostic Reagents (draft)” and “Administrative Measures for the Registration of In Vitro Diagnostic Reagents”.
On October 29, 2021, the NMPA published the “Classification Rules for In Vitro Diagnostic Reagents” for the first time, exerting significant influences on the IVD industry.
Main Factors for Classification IVD Rules
Referencing IMDRF (International Medical Device Regulators Forum) classification principle, the Rules list the main factors affecting the degree of product risk as:
- The intended use and indications of the product, the intended use environment and the professional knowledge of the user
- The extent to which the information of the test results affects medical diagnosis or treatment
- The impact of the test results on personal and/or public health.
The Rules classify the in vitro diagnostic reagents by three categories:
- for detection of pathogenic pathogen antigens, antibodies and nucleic acids
- for blood type and tissue matching
- for human genetic testing
- for detection of genetic diseases
- for detection of narcotic drugs, psychotropic drugs, and medical toxic drugs
- companion diagnostic reagents for detection of target points of therapeutic drugs
- companion diagnostic reagents for evaluation of safety and effectiveness of related medical products.
- for tumor screening, diagnosis, auxiliary diagnosis, staging, etc.
- for protein detection
- for sugar detection
- for hormone detection
- for enzyme detection
- for ester detection
- for vitamin detection
- for inorganic ion detection
- for the detection of drugs and drug metabolites
- for autoantibody detection
- for microbial identification or drug susceptibility testing, and cell culture media used for cell proliferation
- for allergen detection
- for detection of other physiological, biochemical or immune function indicators.
- microbial culture medium not used for microbial identification or drug susceptibility test
- products for sample processing, such as hemolytic agents, diluents, staining solutions, nucleic acid extraction reagents, etc.
- general reagents for the reaction system, such as buffer, substrate solution, enhancement solution, etc.
The rules also specify circumstances where attention shall be paid and discussion with NMPA shall be needed. For an English copy of the “Classification Rules for In Vitro Diagnostic Reagents”, please email info@ChinaMedDevice.com.
For IVDs exempted from the clinical trial, please click HERE
For the Guideline of Overseas Clinical Data Acceptance on IVDs (draft), please click HERE
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