NMPA published the seven IVD reagents guidelines on March 31, 2025. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process:
- Guideline on Stability Study of In Vitro Diagnostic Reagents
- Guideline on ALDH2 Gene Polymorphism Detection Reagents
- Guideline on Human MTHFR Gene Polymorphism Detection Reagents
- Guideline on Estrogen Receptor and Progesterone Receptor Antibody Reagents and Detection Kits
- Guideline on Fully Automated Chemiluminescence Immunoassay Analyzer
- Guideline on Hepatitis B Virus Genotyping Detection Reagents
- Guideline on Hepatitis C Virus RNA Detection Reagents
Regulatory Advancements
The 2025 Revised IVD Classification Catalog streamlines regulatory pathways by categorizing products into 25 primary and 1,852 secondary classes, with clear risk-based management tiers (Class I–III).
The above guidelines are introduced to enhance product safety and market transparency.
Click HERE for our recorded webinar on “Understanding IVD Reagents Registration Requirements: China & US Perspectives”.
Click HERE for the proposed clinical trial exemption catalog.
- Stability Studies: The Guideline on Stability Study of In Vitro Diagnostic Reagents mandates rigorous evaluation of reagent shelf life and storage conditions, ensuring reliability across diverse clinical environments.
- Genetic Testing Standards: Guidelines for ALDH2 and MTHFR gene detection establish standardized protocols for polymorphism analysis, critical for personalized treatment in cardiovascular and metabolic diseases.
- Infectious Disease Management: HBV genotyping and HCV RNA detection guidelines refine viral load monitoring and drug resistance profiling, addressing China’s high burden of hepatitis infections.
- Quality Control in Oncology: ER/PR antibody kit guidelines ensure consistency in hormone receptor testing, vital for breast cancer therapy decisions.
Growth Drivers
China’s IVD market is characterized by rapid technological adoption, particularly in molecular diagnostics (e.g., ALDH2 and MTHFR gene polymorphism detection) and immunoassays (e.g., chemiluminescence analyzers). Key growth areas include infectious disease testing (e.g., HBV genotyping and HCV RNA detection), oncology (e.g., estrogen/progesterone receptor antibody kits), and genetic screening, aligning with the NMPA’s emphasis on precision medicine. The demand for automated systems, such as fully automated chemiluminescence immunoassay analyzers, is also surging due to their efficiency in high-throughput clinical settings.
Related Manufacturers
According to FDA and NMPA databases, the below foreign manufacturers are related to the newly-released guidelines.
ALDH2 Gene Polymorphism Detection Reagents:
- Thermo Fisher Scientific
- Illumina
- QIAGEN
- Roche Molecular Diagnostics
Estrogen Receptor and Progesterone Receptor Antibody Reagents And Detection Kits
- Dako
- Roche Diagnostics
- Leica Biosystems
Fully Automated Chemiluminescence Immunoassay Analyzer
- Abbott
- Roche
- Siemens
Hepatitis B Virus Genotyping /Hepatitis C Virus RNA Detection Reagents
- Roche Molecular Systems
- Abbott Molecular
- Hologic
- Cepheid