China Issues Specifications of Creating Periodic Risk Assessment Report for Medical Devices

The National Medical Product Administration (NPRA of China) has published specifications for creating a Periodic Assessment Report for Medical Devices(NO. 46 of 2020). The specification is to meant to provide a standard guideline for medical registrants  (hereinafter referred to as registrants) to write periodic risk assessment reports pursuant to “Medical device Adverse Events Monitoring and Re-evaluation Management Measures” (State Administration of Market Supervision and Administration, National Health Commission Order No. 1 ) (hereinafter referred to as the “Measures”).


The specification applies to the holder of the medical device marketing license mentioned in the measures.
This specification is formulated based on the current understanding of periodic risk assessment reports and proposes general requirements for writing. However, the actual situation is relatively diverse and it is difficult to cover everything. Specific issues not covered by this specification should be studied and determined based on actual conditions. At the same time, as medical device registrants regularly summarize the experience accumulation of medical device safety information, changes in regulatory requirements, and the continuous development of science and technology, this specification will also be adjusted in due course.

Kindly refer to 国家药监局关于发布医疗器械定期风险评价报告撰写规范的通告 (2020年第46号) for further information

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