CMDE Issues Notice About Clinical Trials on Nucleic Acid Testing Reagents in China

On February 28, 2025, China's medical device regulatory authority (CMDE) issued a notice, establishing new requirements for clinical trials of nucleic acid testing reagents compatible with both rapid and conventional testing devices. The announcement responds to some uncertainties with respect to clinical trial requirements for different types of reagent tests.

CMDE's Department of Clinical and Biostatistics II was the issuing department for the notice.

According to this notice, if the diagnostic performance of the reagents is consistent across both types of devices, clinical trials should primarily use representative rapid testing devices and include a certain number of samples to compare results between rapid and conventional devices.

Technological Development and Innovation Trends

Nucleic acid testing reagent technology is advancing towards faster, more convenient, and smarter directions. For instance, the emergence of COVID-19 nucleic acid home self-testing technology has greatly enhanced the accessibility and convenience of nucleic acid testing by enabling it in home environments. Furthermore, the integration of AI and IoT technologies promises to equip future nucleic acid testing reagents with stronger automation and data processing capabilities.

CMDE's Guiding Principles

To ensure the safety and effectiveness of nucleic acid testing reagents, CMDE has released a series of guiding principles that clarify core requirements for clinical trial design. These principles emphasize reasonable sample size, accurate diagnostic results, and comparative studies with existing standards. Nucleic acid reagent manufacturers must strictly follow these guidelines when designing clinical trials to ensure results meet the requirements of Chinese regulators.

Compared to existing regulations, these changes place greater emphasis on the actual application performance of products and the necessity of clinical validation.

Further Information

To read the original Center for Medical Device Evalation announcement about nucleic acid testing reagents, please click here. If you have specific questions about how the changes to nucleic acid testing reagent regulation may affect you, please contact Cisema.

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