China Medtech A key regulatory milestone for China’s Brain-Computer Interface (BCI) market

研报英文原文证据摘录

China Medtech A key regulatory milestone for China’s Brain-Computer Interface (BCI) market

rst comprehensive regulatory framework covering product

definition, classification and naming. They remove a major source of regulatory

uncertainty that previously complicated product development and registration, while

establishing clear pathways for different product categories. In particular, the risk-based

classification system balances innovation and patient safety by maintaining stringent

Class 3 oversight for invasive and therapeutic applications while allowing selected non-

AI stroke rehabilitation BCIs to pursue a lower-risk Class 2 pathway. In our view, greater

regulatory clarity should facilitate clinical adoption, attract additional industry

investment and accelerate the commercialisation of BCI products in China, especially in

neurorehabilitation and functional restoration settings.

… but challenges for domestic companies remain to be addressed

Despite improving regulatory clarity, there are still bottlenecks for local BCI firms,

particularly invasive BCI companies. We recently hosted a lunch meeting with a BCI

expert in our medtech tour (takeaways) and the expert highlighted the following

challenges: 1) Electrodes. High channel count electrodes (above 256 channels) remain

dependent on imported materials and precise manufacturing. The long-term stability of

domestic alternatives may fall short of clinical requirements currently. Meanwhile, rising

channel counts are associated with more pronounced heat generation, which could limit

durability and sustained use in clinical settings. 2) Chips. Real-time neural decoding

requires customized chips with both high computing power and low power

consumption, typically at the 65nm/55nm process node. Although domestic chip