Periodic Risk Evaluation Report: China’s NMPA Further Specifies PMS Requirements

China Periodic Risk Assessment Evaluation Report

China’s NMPA now requires your submission of a Periodic Risk Assessment Evaluation Report, based on the initial NMPA registration time. This requirement is specified in Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation (published on Aug 13, 2018, effective since Jan 1, 2019). Each Market Authorization Holder needs to fulfill this requirement and submit a report at a certain time point.

We have formulated a template for your China Periodic Risk Evaluation Report. Email info@ChinaMedDevice.com to get a copy.

On May 6, National Center for ADR Monitoring issued a notice “Issues on Implementation of Periodic Risk Assessment Reports for Medical Device Adverse Events”. It guides MAHs (market authorization holders) to identify what kind of information to include in this report. Such information shall be provided to your China legal representative to compile to a final report. It is important to collect the information and make them available to your legal representative because NMPA is relying on post-market surveillance to achieve full regulatory compliance.

Guidelines

A legal representative will play a far more significant role than ever before, with Decree 1 and the Guideline for Medical Device Market Authorization Holders (MAHs) to Conduct Adverse Event Monitoring. China Med Device, LLC is an NMPA certified legal representative. We can help you fulfill the pre and post-market legal agent requirements without your need to set up an office in China. For more details on legal representative related regulations, email us at info@ChinaMedDevice.com.

The notice clarified the following:

1. The submission deadline is September 30, 2020.
2. For Class II and Class III medical devices that are in the first registration cycle as of January 1, 2019, the registrants should submit the supplementary 2019 annual risk assessment report by September 30, 2020.
3. Registrants should submit the report once a year, and the data collection start date should be consistent with the time when the registration certificate is obtained.
4. For Class I devices, the report should be written annually in the first five years (No need to be submitted to NMPA); No reports are required after the five-year period.
5. Different reports can be combined If:
   • Multiple registration certificate numbers are obtained for a device’s different models (such as different models of the disposable sterile syringe), or
   • Multiple registration certificate numbers are obtained for products that must be used together (such as acetabular cups and femoral stems in hip joints system, etc.), in the case of meeting the time limit for the completion of their respective periodic risk assessment reports, they can jointly write periodic risk assessment reports.
6. In the combined reports, relevant products’ information should be noted upon submission of archiving; For similar products, the subgroup analysis per the registration certificate numbers is required.

There are different reporting requirements under initial registrations and renewals. For more information please contact us at info@ChinaMedDevice.com.