41.12% Reports are from Class III Devices, 2025 Medical Device Annual AE Report Says

On July 23, 2026, the National Center for ADR Monitoring (NCDR) of China released its annual report on medical device adverse event monitoring for 2025, providing a comprehensive overview of the system’s performance. The year saw continued growth in reporting volumes, enhanced risk evaluation capabilities, and deeper international engagement, all aimed at strengthening the post-market surveillance of medical devices and ensuring patient safety.

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Key Progress in Monitoring and Vigilance

In 2025, China’s medical device monitoring system operated under a strategic framework emphasizing scientific evaluation, risk management, and patient-centered service. Major achievements included:

• Improved Reporting Quantity and Quality: The National Medical Device Adverse Event Monitoring Information System received over 1 million reports, equivalent to 709 reports per million population – an increase of 5.70% and 5.66% respectively from 2024. Quarterly quality assessments by provincial agencies helped maintain and improve data integrity.
• Enhanced Risk Evaluation: A closed-loop risk management approach was implemented, ensuring timely detection, assessment, and mitigation of product risks. The NCDR published **12 issues** of the “Medical Device Vigilance Newsletter” in 2025, summarizing 63 safety alerts from regulators in the US, UK, Australia, and Canada. The “14th Five-Year Plan” key monitoring project for medical devices was successfully concluded, with active collaboration from monitoring bodies, hospitals, and registrants.
• Innovative Vigilance Methods: Pilot programs for medical device vigilance were expanded. Key technical documents, including the “Medical Device Vigilance Quality Management Specification (Pilot Version)” were revised. Research under the National Drug Regulatory Science Action Plan was completed, and China began implementing seven adverse event terminology categories from the International Medical Device Regulators Forum (IMDRF). Active surveillance research under the Global Harmonization Working Party (GHWP) also advanced.

Detailed Report Analysis

• Total Reports: 1,000,100 reports in 2025 (up 5.70% year-on-year).
• Reports per Million: 709 (up 5.66%).
• Registered Users: As of December 31, 2025, there were 447,000 registered grassroots users in the system, a 3.64% increase from 2024. This comprised 40,600 registrants (manufacturers), 269,100 operating enterprises (distributors), and 137,300 user facilities (medical institutions).
• Source of Reports: Medical institutions submitted the vast majority – 899,100 reports (89.90%). Operating enterprises contributed 61,600 (6.16%), and registrants submitted 38,900 (3.89%). Other sources accounted for the rest.
• Severity of Injury: Reports classified as serious injury or death numbered 85,300 (8.53%), while 914,700 (91.46%) were non-serious.
• Device Classes: Class II (moderate risk) devices accounted for the largest share with 507,200 reports (50.72%), followed by Class III (high risk) with 411,300 (41.12%), and Class I (low risk) with 72,100 (7.21%). Unclassifiable reports were 9,500 (0.95%).
• Device Structure: Non-active (passive) medical devices generated 678,100 reports (67.80%), active devices generated 304,800 (30.48%), and IVD reagents generated 7,700 (0.77%).
• Place of Use: The vast majority of events occurred in medical institutions (930,800 reports, 93.07%), with home use accounting for 54,400 (5.44%) and other locations for 14,900 (1.49%).

Top Device Categories

The report ranked categories from the Medical Device Classification Catalog by the number of adverse event reports received in 2025. The top ten categories are presented below.

Top Ten Medical Device Categories by Adverse Event Report Volume (2025)

International Vigilance Communication

The NCDR actively participated in IMDRF and GHWP working groups, contributing to projects on adverse event terminology and active surveillance. The 12 issues of the “Medical Device Vigilance Newsletter” disseminated 63 international safety alerts, providing valuable reference for domestic risk assessments.