National Medical Products Administration Issues Notice! New Regulations on Dynamic Adjustments to the Medical Device Classification Catalog Are Here

On June 1, 2026, the National Medical Products Administration officially released the “Announcement on the Issuance of the Work Procedures for Dynamic Adjustments to the Medical Device Classification Catalog” (No. 53 of 2026), systematically revising and optimizing the current dynamic adjustment mechanism for the medical device classification catalog. The new procedures take effect as of the date of the announcement and simultaneously repeal Version No. 60, issued in 2021.

Policy Background and Objectives

This revision is based on higher-level regulations such as the “Regulations on the Supervision and Administration of Medical Devices” and the “Rules for the Classification of Medical Devices.” It aims to further strengthen the classification management of medical devices and enhance the scientific rigor, flexibility, and adaptability of the classification catalog. By standardizing the dynamic adjustment process, the revision seeks to promptly respond to technological advancements, changes in risk profiles, and clinical application needs, thereby ensuring the safety of medical devices for the public.

Key Areas of Adjustment

The new working procedures focus on optimizing the following aspects:

Adjustment Trigger Mechanism: Clarifies channels for adjustment proposals submitted by diverse stakeholders, including enterprises, academic societies, associations, and regulatory authorities, and shortens response cycles.

Technical Review Process: Strengthens the independent review role of the Classification Technical Committee and refines the steps for technical justification, risk analysis, and public consultation.

Catalog Update and Publication: Establishes a dynamic maintenance model combining annual centralized adjustments with emergency individual adjustments to ensure the timeliness and transparency of catalog information.

Transition from Old to New: Principles for the transition period are stipulated to minimize the impact on products already on the market.

Brief Analysis of Industry Impact

For Registrants/Filing Entities: Future product classification pathways may better align with actual risks, helping to reduce registration delays or increased compliance costs caused by improper classification.

Innovative Devices: A faster and clearer channel for classifying products involving new technologies and materials is established, facilitating the commercialization of innovative achievements.

Regulatory Coordination: Dynamic adjustments will be more closely integrated with systems such as medical insurance coding and adverse event monitoring, promoting full-lifecycle regulation.

Next Steps

The National Medical Products Administration (NMPA) has simultaneously released the full text of the “Procedures for Dynamic Adjustment of the Medical Device Classification Catalog” (see attachment). Relevant enterprises, research institutions, and clinical units are advised to review the document promptly and monitor subsequent announcements regarding specific adjustments to the classification catalog. The industry can use this opportunity to proactively review their product lines and actively participate in providing feedback on classification adjustments.

Source: Announcement on the NMPA Official Website (No. 53, 2026)