China NMPA Releases Draft Clinical Trial Guideline for Implantable Brain-Computer Interface Hand Motor Function Compensation Systems

On July 31, 2026, the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration (NMPA) officially released a draft document for public consultation: the Clinical Trial Technical Review Guidelines for Implantable Brain-Computer Interface Hand Motor Function Compensation Systems (Draft for Comments).

I. Issuing Authority & Background

This guideline was developed by the CMDE to better assist applicants in preparing and drafting registration dossiers. It synthesizes risk-benefit information and clinical research to standardize technical review processes and ensure consistency in evaluation.

II. Scope of Application

The product typically consists of an implantable BCI device, implantable EEG electrode kit, disposable surgical tool kit, EEG signal transceiver, pneumatic glove device, EEG decoding software, medical testing software, clinical management software, charger, implantable leads, electrodes, and implantation tools. Under the current Medical Device Classification Catalog, the product code is 12-04-01, with Class III management category.

The intended use is for tetraplegic patients with cervical spinal cord injury (aged 18–60, C2–C6, ASIA A–C, diagnosed >1 year and stable for ≥6 months after standard treatment), assisting hand grasping function via a pneumatic glove device. This guideline provides general requirements for epidurally implanted devices with low-channel-count local field potential decoding targeting the hand knob area.

Not applicable to: non-invasive BCI products; subdural, intracortical, deep brain, or cerebrovascular implants; devices targeting areas outside the hand knob area; devices controlling other external equipment or achieving other clinical functions; or patient populations beyond cervical spinal cord injury-induced tetraplegia.

III. Key Clinical Trial Requirements

Implantable BCI devices are high-risk products requiring clinical trial pathways for evaluation. Domestic trials must comply with GCP requirements. Feasibility trials (minimum 4 cases) are recommended before confirmatory trials.

Primary endpoint: BCI-assisted ARAT grasp response rate at 6 months post-implantation, defined as improvement ≥ Minimal Clinically Important Difference (MCID) from baseline unassisted ARAT grasp score. MCID should not be less than 2 points.

Sample size: Assuming a target response rate of 50%, expected response rate of 75%, α=0.025 (one-sided), power 1-β=0.8, with 10% dropout, total sample size recommended ≥32 cases.

Post-market follow-up of ≥2 years is required, focusing on adverse events, unassisted grasping ability, quality of life, electrode reliability, and decoding accuracy.

IV. Labeling Requirements

Instructions must specify: hand knob area implantation verification methods (via neuroelectrophysiological signals and MRI); motor imagery training paradigms; adverse events, complications, and potential risks (including hardware and physiological risks associated with long-term electrode implantation such as subdural effusion and electrode failure); system initialization calibration standards; and quantitative thresholds triggering model retraining.

Public Comment Deadline: August 19, 2026

Please submit completed feedback forms via email. Subject line and file name should follow: "Feedback on the Draft Clinical Trial Technical Review Guidelines for Implantable BCI Hand Motor Function Compensation Systems".

Contacts:

Cui Xinyue, Jiang Yan, Wang Zehua

Tel: 010-86452502 / 010-86452514 / 010-86452521

Email: jiangyan@cmde.org.cn / wangzh@cmde.org.cn

A critical milestone for China's BCI medical device regulatory landscape. Industry players, research institutions, and clinical experts are encouraged to review and submit their professional feedback.