Key Points of the Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events (State Administration for Market Regulation and National Health Commission Order No. 1)

Basic Information on the Document

The Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events were jointly issued by the State Administration for Market Regulation and the National Health Commission by Order No. 1 on August 13, 2018, and took effect on January 1, 2019. They apply to "the monitoring and re-evaluation of medical device adverse events carried out within the territory of the People's Republic of China, and the supervision and administration thereof."

Responsibilities of Each Party

Medical device marketing authorization holders must establish an adverse event monitoring system, report adverse events directly to the National Medical Device Adverse Event Monitoring Information System, and conduct evaluations; distribution enterprises and using entities must report known or discovered adverse events to holders and monitoring institutions; the in-China agent of an overseas holder undertakes the domestic monitoring work for imported devices.

Reporting Time Limit Requirements

The Measures establish a tiered reporting system: adverse events that result in death must be reported within 7 calendar days from the date of becoming aware of them; those that result in serious injury or are life-threatening must be reported within 20 calendar days; and others must be reported within 30 calendar days. For group adverse events, the holder must initiate the emergency reporting procedure within 12 hours after becoming aware of them.

Re-evaluation and Control Measures

Holders must conduct risk evaluations on a regular basis and, where necessary, initiate the re-evaluation procedure. Regulatory authorities may, in accordance with the law, take measures such as ordering revision of the instructions for use, suspending sale and use, ordering a recall, and even cancelling the registration certificate to control risks.

Source: State Administration for Market Regulation and National Health Commission, Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events (SAMR Order No. 1), National Medical Products Administration, https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20180831121501654.html