Abstract:
Objective To explore the current management status and challenges of brain-computer interface（BCI） rehabilitation medical devices. The existing classification system in China faces several problems, including a single classification dimension, insufficient risk adaptation, and having difficulties in coping with technological iteration. This study aims to propose scientific classification ideas and promote the healthy and orderly development of such devices in the medical field.
Methods By sorting out the regulatory experience of the United States, the European Union and Japan, combining the current situation of BCI technology research and classification management in China, this study analyzes the technical characteristics of BCI products and the current status of "ambiguous definition and classification, and pending update of regulations and standards". On this basis, a three-dimensional classification model based on "function, risk and invasiveness" is constructed.
Results The core function of these products is defined as "collecting electroencephalographic signals to identify patients’ intentions for rehabilitation training or adjuvant therapy". Subdivisions such as "invasive/non-invasive" and "rehabilitation training/augmentative and alternative communication/mental illness treatment" are achieved. For example, multi-functional devices for stroke patients are classified as "medium risk". International practices are integrated to overcome the limitations of traditional classification, providing a path for China to learn from international ideas. Space is reserved for technological iteration, such as new electrodes and artificial intelligence algorithms.
Conclusion By clarifying functional purposes and risks, the proposed classification idea provides a basis for supervision. It can be optimized with the expansion of technology and scenarios, and it helps make the classification of BCI products more scientific.
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