NMPA CMDE Releases Draft Technical Review Guidelines for Implantable BCI Motor Function Compensation Medical Devices

On August 18, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) officially released the Technical Review Guidelines for Implantable Brain-Computer Interface Motor Function Compensation Medical Devices (Draft for Public Comment).

Core Positioning

This document consolidates key technical requirements for the safety, efficacy, and quality control of implantable BCI medical devices. It synthesizes risk-benefit analyses and scientific research to standardize technical review and unify assessment criteria. The guidelines serve as reference for registration applicants in preparing submission dossiers. They are not mandatory regulations and should be applied in conjunction with laws, regulations, and mandatory standards, tailored to product-specific characteristics.

Scope of Application

The guidelines apply to registration applications for implantable BCI motor function compensation medical devices, classified under Category 12‑00, Class III. Other types of implantable BCI devices—such as audio-visual perception reconstruction and closed-loop neuromodulation—may reference applicable provisions.

Product Composition

Such products typically consist of implantable electrodes, implantable signal processors, decoding devices or software, patient training and clinical management software, effector devices, power supply devices, and surgical tools. Implanted components remain in the human body for 30 days or more. The products are intended for patients with motor dysfunction due to central nervous system injury, enabling motor function compensation by real‑time acquisition of motor brain region signals, decoding patient motor intent, and controlling effector devices.

Three Core Review Elements

Signal acquisition, signal decoding, and effector device control are the three core elements for achieving intended use and the focal points of technical review.

Signal Acquisition: Brain signals are primarily EEG signals, including electrocorticography (ECoG), local field potentials (LFP), and spikes. Electrodes are classified by implantation site as fully invasive (brain parenchyma), semi‑invasive (inside/outside the meninges), and interventional (within cerebral blood vessels).

Signal Decoding: Decoding algorithms are categorized as rule‑based white‑box or data‑driven black‑box algorithms. Performance metrics must be clinically driven, accounting for patient variability and intra‑patient state changes.

Effector Devices: These include general electronic devices, motor devices (e.g., pneumatic gloves, robotic hands, robotic arms), and electrical stimulation devices, each enabling different functions.

Key Review Focus Areas

The guidelines cover the entire review chain: general information, non‑clinical data, clinical evaluation, labeling, quality system inspection, and change registration. Key areas include:

Product risk management (per GB/T 42062)

Checklist of essential principles for safety and performance

Product technical requirements and testing

Research data on physical/mechanical properties, chemical and material characterization, electrical safety, radiation safety, software (including decoding algorithms), biocompatibility, animal testing, usability, and stability

Public Comment Period

Comments and suggestions should be submitted via the feedback form by email to CMDE no later than September 7, 2026. The email subject and file name should follow the format: "Feedback on Technical Review Guidelines for Implantable BCI Motor Function Compensation Medical Devices".

Contact: Peng Liang

Phone: 010‑86452602

Email: pengliang@cmde.org.cn