NMPA Releases Classification and Generic Naming Guidelines for Brain-Computer Interface Medical Devices

Full Translated Core Content

Release date: June 30, 2026

To further strengthen the supervision and administration of brain-computer interface medical device products and promote high-quality industry development, the National Medical Products Administration (NMPA) has organized the formulation of the Guiding Principles for Classification Determination of Brain-Computer Interface Medical Devices and the Guiding Principles for Generic Naming of Brain-Computer Interface Medical Devices, and hereby releases them.

The two guiding principles take effect on the date of release. Applicants shall determine the management attributes, management classification, and generic name of brain-computer interface medical device products in accordance with the corresponding guiding principles.

Hereby announced.

Attachments:

• Guiding Principles for Classification Determination of Brain-Computer Interface Medical Devices
• Guiding Principles for Generic Naming of Brain-Computer Interface Medical Devices

Issued by: National Medical Products Administration

Date signed: June 29, 2026

Related links:

• Interpretation of the Guiding Principles for Classification Determination of Brain-Computer Interface Medical Devices
• Interpretation of the Guiding Principles for Generic Naming of Brain-Computer Interface Medical Devices

Source and applicability note: Source institution: NMPA Medical Devices. Original date: June 30, 2026. Article publication date: July 9, 2026, 15:00. This article is compiled and organized from public information published by NMPA Medical Devices. Source: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260630140449128.html. Specific requirements are subject to the latest official release of the regulatory authority.

AIMEILI Regulatory Interpretation and Business Impact

The two BCI guidelines released by NMPA on June 30, 2026 mark a move toward standardized regulation of emerging brain-computer interface medical devices in China. From AIMEILI's regulatory affairs perspective, the guidelines have significant implications for Chinese medical device companies, especially those developing BCI products, in several areas.

1. Registration pathway and product classification

Previously, classification of BCI medical devices was relatively unclear, and companies often faced classification uncertainty. The new Classification Determination Guiding Principles clarify the basis and method for classification. Companies need to reassess the management attributes and classification of existing and in-development products. For products already registered under the previous classification, variation registration or supplementary materials may need to be considered. For new products, accurate classification will directly determine the registration pathway, for example Class II or Class III, technical review requirements, and eligibility for clinical trial exemptions. Companies should organize regulatory teams to conduct a clause-by-clause self-check against the guiding principles as soon as possible and communicate with the drug regulatory authority when necessary.

2. Technical documentation and clinical evaluation

Once classification is determined, the content and depth of technical documentation, such as product technical requirements, performance verification reports, and clinical evaluation materials, must match the classification requirements. For example, if a product is classified as Class III, clinical trial data are generally required; if classified as Class II, comparison with an equivalent device or literature data may be sufficient. The Generic Naming Guiding Principles set out naming rules for generic names. Companies need to ensure consistency among the product name, labeling, instructions for use, and registration materials to avoid registration corrections or market access obstacles caused by non-standard naming.

3. Quality management system

BCI products involve multidisciplinary technologies, and the quality management system needs to cover software, hardware, algorithms, and other elements. Although the guiding principles do not directly address the quality management system, changes in classification may trigger adjustments to system audit requirements. For example, Class III products generally require stricter design controls, risk management such as ISO 14971, and software lifecycle processes. Companies should assess whether existing system documents meet the new requirements, particularly for BCI-specific controls related to signal acquisition, algorithm validation, and patient safety risk control.

4. Post-market maintenance

For marketed products, companies should monitor whether the guiding principles require adjustments to the original classification or name. If changes are required, a transition plan should be developed, including label replacement, instructions for use revision, and updated adverse event monitoring. In addition, NMPA released interpretations of the two guiding principles at the same time. Companies should review them carefully to ensure accurate understanding of the applicable circumstances of the provisions.

Business impact

• Classification outcomes may change Class II or Class III pathways, clinical evidence requirements, and review timelines.
• Companies may need to update technical documentation, labels, instructions for use, and registration dossiers to align product names and claims.
• Quality system audits may require stronger design controls, risk management, and software lifecycle evidence for BCI-specific functions.
• Marketed products may require transition plans for labeling, instructions, and post-market surveillance if classification or naming changes.

Practical compliance assessment

When assessing the requirements, companies should consider the target country regulatory pathway, product risk level, technical file basis, labeling language, local authorized representative, and post-market maintenance obligations. Companies should prioritize checking the intended use, classification basis, ISO 13485 quality management system evidence, risk management file, performance verification data, clinical evaluation or clinical evidence, labels and instructions for use, authorization documents, and existing registration certificates.

Common risks include unclear classification determination, an incomplete evidence chain, non-localized labels and instructions for use, unclear responsibilities of the authorized representative, and insufficient post-market maintenance arrangements.

In summary, companies should attach high importance to these two guiding principles, use them as foundational documents for BCI product compliance, and promptly adjust registration strategies and technical documentation to reduce compliance risks and accelerate market access.

FAQ

Can the June 30, 2026 NMPA guidelines be used directly as the basis for a registration submission?

No. These guidelines should not be used directly as the sole basis for a formal submission. This article is for preliminary understanding and project assessment; formal submissions must still be based on the latest requirements of the target country regulator, the product classification conclusion, and the company's documentation.

What should companies do first after seeing this regulatory update?

Conduct a documentation gap assessment first. Companies should confirm whether the update affects the registration pathway, technical documentation, labeling, quality management system, or post-market maintenance obligations.

Applicability Boundary

This article is for preliminary understanding, document preparation, and project planning and does not replace the formal requirements of the target country regulatory authority, testing conclusions, or legal opinions. For registration pathway assessment, companies may provide the product name, intended use, target countries, and existing documentation basis; AIMEILI can assist in determining registration pathways, documentation gaps, and compliance risks.