Has the Window for Obtaining Class III Certification for Invasive Brain-Computer Interfaces Opened After the Joint Policy Release by Seven Ministries?

Recently, the Ministry of Industry and Information Technology and six other departments jointly issued the "Implementation Opinions on Promoting the Innovative Development of Brain-Computer Interface Industry," pushing the already highly popular brain-computer interface to a new peak of attention. Among the highlights, the statement "increased registration guidance and prioritized support for key products such as implantable brain-computer interfaces" has particularly encouraged companies in the invasive brain-computer interface sector. This is because, so far, no invasive brain-computer interface product has been approved for a Class III medical device certificate in China.

On September 20, the National Medical Products Administration released China's first brain-computer interface medical device standard — "Terminology for Medical Devices Using Brain-Computer Interface Technology" medical device industry standard. The密集release of relevant documents makes people feel the dawn of invasive brain-computer interfaces moving from "technical exploration" to "industrial implementation."

Against this backdrop, VCBeat specially organized an online roundtable event on the theme of "After the joint issuance of documents by seven departments, has the 'certification window' for invasive brain-computer interface Class III certificates arrived?"This roundtable invited three guests: Li Xiaojiang, founder and chairman of WE-LINKING, Xu Yulin, director of the Quality Registration Department of StairMed, and Xing Hui, head of the Registration Department of BCIFlex. They engaged in in-depth discussions on core issues such as the guiding significance of standard implementation for product registration, differences in approval processes between China and abroad, and challenges in clinical validation.Thereby further clarifying the collaborative logic of technology transformation and compliance advancement, providing practical reference for the standardized development of the industry.

At 4 PM today,VCBeat Live Studio, see you there!