NMPA CMDE Seeks Public Comments on Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)

NMPA CMDE Seeks Public Comments on Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)

On August 31, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued a notice to solicit public comments on the "Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)". The document aims to guide applicants in preparing and writing clinical trial application materials, covering core requirements such as clinical trial design, evaluation indicators, and safety considerations for brain-computer interface medical devices. Relevant manufacturers, research institutions, and clinical research units should submit feedback by September 14, 2026, so that the formal review guideline can fully incorporate industry suggestions.

Source and Applicability

Source: CMDE Notices. Original publication date: 2026-08-31. This article is compiled from public information from CMDE Notices. Source: https://www.cmde.org.cn/xwdt/zxyw/20260831102738147.html. Specific requirements are subject to the latest official release by the regulatory authority.

Full Translation of the Original Notice

Notice on Public Consultation for the "Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)"

To all relevant units:

In order to further guide applicants in the preparation and writing of registration application materials, our center has organized the drafting of the "Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)" (Attachment 1), and is now soliciting public comments.

If you have any comments or suggestions, please fill out the feedback form (Attachment 2) and send it to our center by email before September 14, 2026. The email subject and file name should be in the format: "Feedback on Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function)".

Contact: Jiang Yan, Wang Zehua

Tel: 010-86452521, 010-86452514

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

Attachments:

• Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)
• Feedback Form

National Medical Products Administration

Center for Medical Device Evaluation

August 28, 2026

AIMEILI Regulatory Interpretation and Business Impact

What This Means for Medical Device Companies

For updates released by CMDE Notices, companies should first determine whether they belong to regulatory policies, guidelines and standards, recall safety, product performance, quality systems, or post-market surveillance information. Different types of information have different impacts on registration pathways, technical files, labeling and instructions for use, risk management, and market maintenance, and cannot be simply treated as industry news.

For Chinese medical device companies, the key is to translate the news into actionable compliance actions: confirm whether it involves similar products, similar technology routes, or similar risk points; check whether existing documents still support target market requirements; and update risk management, performance verification, clinical evaluation, labeling and instructions, distributor communication, and post-market surveillance records when necessary.

Key Documents to Prioritize

It is recommended to prioritize reviewing the product's intended use, classification basis, ISO 13485 quality system certification, risk management documents, performance verification data, clinical evaluation or clinical evidence, labeling and instructions for use, authorization documents, and existing registration certificates.

Common Risks

Common risks include unclear classification determination, incomplete evidence chains, non-localized labeling and instructions for use, unclear responsibilities of authorized representatives, and inadequate post-market maintenance arrangements.

AIMEILI View

The release of the "Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment)" marks the accelerating refinement of China's regulatory framework for brain-computer interfaces, a cutting-edge medical device. Implantable brain-computer interfaces involve multiple complex steps such as electrode implantation, neural signal acquisition, algorithm decoding, wireless communication, and external device control. The evaluation of long-term safety and effectiveness has extremely high technical thresholds. By soliciting comments this time, the CMDE essentially aims to advance the evaluation requirements of the clinical trial stage to the registration review stage, using systematic guidance standards to lead companies in conducting scientific clinical research.

From a registration strategy perspective, implantable brain-computer interface systems are likely to be classified as Class III high-risk medical devices. If the intended use involves "cursor interaction control function," then the registration unit division, clinical evaluation pathway, biocompatibility evaluation, and software safety requirements will be very stringent. Companies need to initiate communication with the CMDE as early as possible to confirm product classification, applicable guidelines, and review points, and leverage the special review procedure for innovative medical devices to accelerate market entry of key products. If companies plan to apply for the national innovation channel, the review tendencies reflected in this draft will directly affect the strategy for writing the clinical evaluation section in the innovation application materials.

In the field of clinical evaluation, these points specifically propose clinical trial technical review requirements for "electronic device cursor interaction control function," meaning that applicants cannot simply apply the clinical pathway for general neurostimulation products. Clinical trial design needs to focus on subject selection and sample size estimation, control group selection, primary and secondary efficacy endpoints (such as cursor control accuracy, completion speed, error rate, learning curve), device safety and biocompatibility evaluation, long-term implantation follow-up plans, and risk control measures for postoperative infection, electrode displacement, signal drift, etc. On the hardware side, mechanical safety, electrical safety, electromagnetic compatibility, and wireless coexistence testing need to be completed; animal experiment data, type testing reports, and potentially cybersecurity assessments also need to form a complete evidence chain.

From the perspective of quality system and post-market maintenance, the design and development process of such products should cover implant materials, packaging processes, algorithm reliability, supply chain stability, and full lifecycle risk analysis. Manufacturers need to establish a comprehensive adverse event monitoring system, closely monitor clinical risks such as electrode aging, signal quality degradation, and user and caregiver operating errors, and develop plans for continuous post-market research and real-world data collection. For the Chinese patient population, it is also necessary to evaluate the potential impact of cultural differences, language interfaces, and operating habits on the clinical outcomes of cursor control function.

Although it is currently only a draft for comment, companies should regard it as an important indicator for future registration review. It is recommended that relevant companies study the draft and submit constructive comments before September 14, 2026, with particular attention to subject protection, long-term follow-up periods, and the scientific validity of evaluation indicators. For companies planning to conduct multicenter clinical trials in China, the AIMEILI Regulatory Department recommends conducting a gap analysis in advance, comparing the differences between these points and existing clinical trial protocols, and adjusting technical documents, labeling, and risk analysis reports as early as possible. At the same time, these points can be integrated with international quality management system requirements such as ISO 13485, so that Chinese trial data and management systems can better support global registration applications.

FAQ

Q: Can the August 31, 2026 NMPA CMDE public consultation on the Clinical Trial Technical Review Points for Implantable Brain-Computer Interface Systems (Electronic Device Cursor Interaction Control Function) (Draft for Comment) be directly used as a basis for registration application?

A: No. This article is for preliminary understanding and project assessment. Formal applications must be based on the latest requirements of the target country's regulatory authority, product classification conclusions, and the company's specific documentation.

Q: What should companies do first upon seeing such updates?

A: It is recommended to first conduct a documentation gap assessment to determine whether the update affects the registration pathway, technical files, labeling, quality system, or post-market maintenance.

Content Review and Applicability Boundaries

Author: AIMEILI Regulatory Editorial Team

Professional Review: AIMEILI Medical Device International Registration Project Team

Source Principle: Prioritize official regulatory authorities, international organizations, standards organizations, and public regulatory materials; industry media and project experience are for supplementary judgment only.

Applicability Boundaries: This article is for preliminary understanding, documentation preparation, and project planning. It does not replace the formal requirements of the target country's regulatory authority, testing conclusions, or legal opinions.