The State Administration for Market Regulation of China has approved two new national standards for biochips. These updated guidelines, which replace versions from 2011 and 2013, are scheduled to take effect on February 1, 2027. The move aims to unify terminology and technical requirements across the industry.
The standard for basic biochip terminology, GB/T 27990—2026, introduces updated definitions for nucleic acid, immune, and organ chips. It covers four main areas: basic terms, probes, microarray classification, and microfluidic chip classification. The update is designed to facilitate academic research and international industry cooperation.
The second standard, GB/T 29889—2026, focuses on DNA polymorphism detection microarrays. It mandates that detection sites must be validated by studies involving at least 500 Chinese individuals. Furthermore, it requires a detection rate of at least 99% and an accuracy and repeatability rate of no less than 99.9%.
This standard also establishes strict requirements for the entire testing process, including sample collection, storage, and preprocessing for blood, saliva, and tissue. It mandates the creation of site-association databases and the use of standardized risk assessment software to generate consistent testing reports.
