NMPA Center for Medical Device Evaluation Seeks Public Comments on Clinical Trial Review Guideline for Implantable Brain-Computer Interface Systems

On August 31, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration officially issued a notice soliciting public comments on the "Clinical Trial Technical Review Guideline for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction and Control Function) (Draft for Comments)". The deadline for feedback is September 14, 2026.

This guideline serves as a key technical document addressing the safety and effectiveness of implantable BCI systems for electronic device cursor interaction and control, aiming to standardize technical review processes and unify evaluation criteria. The document covers core chapters including scope, general principles, clinical trial design, and labeling requirements.

Regarding scope, the guideline specifies that it applies to implantable BCI systems utilizing epidural or intracortical implantation, decoding based on local field potentials or neuronal spikes, with relatively high channel counts (e.g., 128 channels or above), and equipped with electronic device cursor interaction and control functionality. Specific recommendations are provided using the example of cervical spinal cord injury patients (C2–C6, ASIA grades A–C) who have been diagnosed for over 12 months with no improvement for at least 6 months despite standardized treatment. Non-invasive BCI products, products implanted outside the hand-knob area, and products controlling other external devices or achieving other clinical functions are outside the scope of this guideline.

Regarding the clinical evaluation pathway, BCI medical devices are classified as high-risk clinical products and require clinical trial pathways for evaluation. Domestic clinical trials must comply with the requirements of the Good Clinical Practice for Medical Devices (GCP). Typically, feasibility clinical trials (with a sample size of no less than 4 subjects) must be conducted successfully before pivotal clinical trials can proceed.

Regarding clinical trial design, the guideline provides detailed requirements. Primary evaluation indicators include the 6-month post-implantation BCI control success rate and the 6-month post-implantation subjective benefit indicator (subjective satisfaction rate). The BCI control success rate is assessed through standardized grid testing (12×12 Webgrid or 8×8 Webgrid) or Center-Out task paradigms. Objective evaluation indicators are categorized into four levels: A, B, C, and D. Regarding sample size estimation, the expected BCI control success rate for the primary objective indicator is 94% with a target value of 80%, while the expected value for the primary subjective indicator is 92% with a target value of 78%. Considering these factors, a total enrollment of 62 subjects (including a 10% dropout rate) is recommended. Pre-market follow-up is generally recommended for at least 12 months post-implantation.

Regarding labeling requirements, in addition to routine information, the instructions for use must clearly present the clinical trial summary, scope of application, implantation brain region and intraoperative localization requirements, motor imagery training paradigms, etc. The specific contents of the three-level daily digital scenarios (essential needs, basic needs, and advanced needs) that the product has demonstrated the ability to complete in clinical trials, as well as the achievable level of objective primary evaluation indicators, must be explicitly listed. Adverse events and potential risks must also be fully disclosed.

Please submit your feedback using the Opinion Feedback Form to the following contacts: wangzh@cmde.org.cn and jiangyan@cmde.org.cn. The email subject and file name should follow the format: "Feedback on the Clinical Trial Technical Review Guideline for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction and Control Function)".

The release of this guideline marks a significant step forward in China's regulatory framework for implantable BCI medical devices. As BCI technology continues to evolve rapidly, scientifically sound and standardized clinical trial review criteria are essential for ensuring patient safety and promoting healthy industry development.