Regulation of Neurotechnology and Brain–Computer Interface Research in China

1. Introduction

Neurotechnology refers to technologies designed to record, interpret, stimulate, or modify the activity of the human nervous system. Brain–computer interfaces (BCIs) are a major category of neurotechnology that enables communication between the brain and external devices without relying entirely on ordinary muscular movement. Applications include restoring movement in patients with paralysis, assisting speech, treating neurological disorders, and developing advanced human–machine interaction systems.

In China, neurotechnology and BCI research is governed by a combination of medical-device regulation, human-subject research ethics, personal-information protection, biotechnology rules, and civil and criminal liability. China does not rely on one comprehensive statute specifically regulating all neurotechnology and BCI research. Instead, the applicable legal requirements depend on whether the technology is invasive or non-invasive, whether it is used for medical treatment or commercial purposes, and whether research involves human participants or sensitive neural data.

The central legal issues are participant safety, informed consent, ethical review, clinical-trial authorization, protection of brain-derived information, and accountability for harm caused by experimental devices.

2. Principal Legislative and Regulatory Framework

A. Biosecurity Law of the People's Republic of China, 2021

The Biosecurity Law establishes a general framework for biological safety, biotechnology research, and the prevention of biological risks. It supports risk-based supervision of biotechnology activities and reinforces institutional responsibility for research safety.

However, it should not be interpreted as a dedicated BCI statute. Ordinary neural signal processing and electronic brain implants do not automatically fall within every provision governing biotechnology. Its relevance depends on the particular biological materials, techniques, and risks involved.

B. Regulations on the Administration of Medical Devices

China's principal medical-device framework is the Regulations on the Supervision and Administration of Medical Devices, revised in 2021. The National Medical Products Administration (NMPA) and relevant provincial authorities supervise medical devices, including products intended for diagnosis, treatment, monitoring, or rehabilitation.

A BCI intended to restore movement, interpret neural signals for medical purposes, or stimulate the nervous system may qualify as a medical device. Depending on its intended use and risk, it may fall within Class II or Class III, with Class III generally covering the highest-risk devices.

Manufacturers and sponsors may need to satisfy requirements concerning product registration, technical documentation, clinical evaluation, quality management, and post-market monitoring. Where a clinical trial is required, additional trial-specific obligations apply.

C. Good Clinical Practice and Human-Subject Research Ethics

China's Good Clinical Practice (GCP) framework governs clinical trials of medical devices and drugs within its respective scope. It requires appropriate trial design, qualified investigators, documented consent, safety monitoring, and reliable clinical records.

The Measures for Ethical Review of Life Science and Medical Research Involving Humans, issued in 2023, establish important ethical-review requirements for covered human life-science and medical research.

A university, hospital, or research institution conducting a human BCI experiment must determine whether its project falls within the applicable ethics-review rules. Invasive implantation, experimental stimulation, and procedures carrying neurological risks require particularly careful assessment of proportionality, participant vulnerability, and long-term follow-up.

D. China's 2024 Ethical Guideline for Brain–Computer Interface Research

In February 2024, China announced a dedicated ethical guideline for BCI research through its national science and technology ethics governance system. This was a significant development because it addressed ethical questions specific to brain–computer interfaces rather than relying exclusively on general biomedical research rules.

State Council Information Office

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The guideline emphasizes:

Beneficence: BCI research should principally assist, enhance, or restore sensory and motor functions and improve human well-being.

Non-maleficence: Researchers must minimize foreseeable physical, psychological, and other harms.

Scientific validity: Experimental procedures should be supported by adequate preclinical evidence.

Informed consent: Participants must understand the purpose, foreseeable risks, and limitations of the research.

Independent ethical review: Relevant research must undergo appropriate ethical scrutiny.

For exceptional clinical trials involving life-threatening rare diseases without effective treatment, the guideline recognizes a restricted pathway subject to informed consent and applicable regulatory requirements.

State Council Information Office

3. Classification of BCI Devices: The 2026 Regulatory Development

On 30 June 2026, China's NMPA published an interpretation of its Guiding Principles for Classification of Brain–Computer Interface Medical Device Products. This provides more specific guidance for determining which BCI products qualify as medical devices and how they should be classified.

nmpa.gov.cn

The guidance distinguishes between invasive and non-invasive devices, their intended medical purpose, and their technical characteristics.

Invasive or implanted BCI medical devices are classified as Class III.

Non-invasive BCI devices intended to treat disease are generally Class III.

Certain non-invasive rehabilitation devices for stroke patients may qualify as Class II when they do not use artificial-intelligence technology; AI-based variants may be Class III.

Non-medical products used for entertainment or ordinary human–computer interaction are outside this particular BCI medical-device classification guidance, although other applicable laws may still govern them.

This distinction matters because classification affects registration, evidence of safety and effectiveness, and the regulatory pathway for clinical investigation. It is not correct to assume that every device using neural signals is automatically a medical device.

nmpa.gov.cn

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4. Protection of Neural Data and Privacy

The Personal Information Protection Law (PIPL), effective from November 2021, is relevant when BCI research collects identifiable neural signals, health information, or other personal data. Neural information may reveal sensitive details about a person's physiological condition and, depending on the technology, aspects of their mental processes.

Where such information qualifies as sensitive personal information, processing generally requires a specific purpose, sufficient necessity, strict protective measures, and separate consent under the applicable statutory conditions.

Researchers must also consider data security, access controls, retention periods, sharing with commercial partners, and cross-border transfers. China's Civil Code provides additional protection for personality rights and privacy.

An important unresolved issue is that Chinese legislation does not yet establish a comprehensive, standalone statutory category specifically for neural data. Legal scholarship has consequently identified gaps concerning cognitive privacy, unauthorized inference, and secondary use of neural information.

Oxford Academic

5. Relevant Case Law and Legal Precedents

There is no well-established body of reported Chinese court judgments specifically deciding the legality of BCI implantation or neural-data misuse. The following precedents are relevant by analogy, rather than direct BCI case law.

A. He Jiankui Gene-Editing Case (2019)

In December 2019, a Shenzhen court convicted scientist He Jiankui and two collaborators for illegally conducting human embryo gene-editing activities. The case resulted in criminal penalties.

Legal significance: The case demonstrates that scientific novelty and potential medical benefits do not exempt researchers from legal and ethical requirements. The same principle is relevant to invasive BCI experiments involving inadequate consent, unauthorized clinical procedures, or violations of applicable medical regulations.

B. Chinese Civil Code: Personality Rights and Privacy

The Civil Code, effective from 2021, protects personal dignity, privacy, and personal information. Although these provisions do not constitute a BCI-specific judicial precedent, they provide a potential legal basis for claims involving unauthorized collection or disclosure of identifiable neural data.

For example, if a research institution discloses a participant's neural recordings without a lawful basis, liability may arise depending on the circumstances, the applicable consent, and the resulting infringement.

C. Medical-Device Regulatory Enforcement

China's medical-device regulatory framework provides administrative and potentially criminal consequences for unlawful manufacturing, marketing, or clinical investigation of regulated devices. The precise consequences depend on the conduct and the applicable statutory provisions. These rules are particularly relevant to unregistered high-risk implants and clinical trials conducted without required approvals.

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6. Conclusion

China regulates neurotechnology and BCI research through overlapping medical-device, ethics, privacy, and general civil-law frameworks. The 2024 BCI ethical guideline and the NMPA's 2026 classification guidance represent important steps toward more technology-specific oversight.

Nevertheless, questions remain about long-term responsibility for implanted devices, cognitive autonomy, cybersecurity, neural-data ownership and control, and post-trial care. For researchers and sponsors, the principal compliance requirements are to establish the device's regulatory classification, obtain the required ethical and regulatory approvals, secure meaningful informed consent, demonstrate adequate safety, and protect neural data throughout the research lifecycle.