China's NMPA CMDE Issues Technical Review Guidelines for Chikungunya Virus Nucleic Acid Detection Reagents
Beijing, August 28, 2025 – The Center for Medical Device Evaluation (CMDE) under China's National Medical Products Administration (NMPA) has announced the release of technical review guidelines for chikungunya virus nucleic acid detection reagents.
Published on August 28, 2025, the notice (No. 17, 2025) aims to strengthen guidance for medical device registration applications and technical review processes. The newly issued "Technical Review Guidelines for Chikungunya Virus Nucleic Acid Detection Reagents (Trial)" provides comprehensive standards for manufacturers developing diagnostic products for this mosquito-borne viral disease.
Key Highlights of the Guidelines:
Scope and Application
The guidelines apply to both new registration applications and variation applications for chikungunya virus nucleic acid detection reagents. These products are classified as Class III in vitro diagnostic reagents under China's medical device regulatory framework.
Technical Requirements
- Detection limit levels must comply with relevant national guideline requirements
- Products must undergo testing with national sensitivity standards where available
- Main raw materials and manufacturing process requirements must be clearly specified in appendix format
Analytical Performance Standards
The guidelines emphasize several critical performance evaluations:
- Sample stability testing
- RNA extraction/purification performance verification
- Precision testing over at least 20 days with specific requirements for negative, borderline positive, and moderate/strong positive samples
- Analytical specificity including cross-reactivity studies with fever-related pathogens and interference testing
- Detection limit determination using statistical models like Probit analysis
- Inclusivity studies covering major chikungunya virus genotypes (West African, East/Central/Southern African, and Asian types)
Clinical Evaluation Requirements
- Clinical trials must be conducted at no fewer than 3 qualified medical device clinical trial institutions
- Trial sites should be located in epidemiologically relevant regions
- For new products, comparison with clinical reference methods (nucleic acid sequencing) is required
- Sample size calculations must meet statistical requirements with clinical acceptance standards of at least 90% for positive/negative concordance rates
- Overseas clinical trial data acceptance follows established NMPA technical guidelines
Regulatory Context
This release reflects China's ongoing efforts to strengthen oversight of diagnostic products, particularly those targeting emerging infectious diseases. Chikungunya fever, transmitted by Aedes mosquitoes, causes symptoms including fever, joint pain, and rash, making accurate diagnostic tools crucial for public health response.
The guidelines take effect immediately and complement existing regulations including the "Announcement on Requirements for Registration Application Materials and Approval Certificate Formats for In Vitro Diagnostic Reagents" (NMPA Announcement No. 122, 2021).
Manufacturers developing chikungunya virus detection reagents must now align their product development and registration strategies with these comprehensive technical requirements to ensure regulatory compliance in the Chinese market.
The CMDE emphasized that while these guidelines provide general requirements, applicants should adapt content based on specific product characteristics, providing scientific justification for any deviations from the standard requirements.