Periodic Risk Assessment Report: NMPA Further Specifies PMS Requirements

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Periodic Risk Assessment Report: NMPA Further Specifies PMS Requirements

A Periodic Risk Assessment Report is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation (published on Aug 13, 2018, effective since Jan 1, 2019). It is the obligation of each Market Authorization Holder to fulfill the requirement and submit this report at certain time point.

We have formulated the template of Periodic Risk Assessment Report. Email info@ChinaMedDevice.com to get a copy.

However, some aspects remained unclear such as when to submit the report after COVID outbreak. On May 6, National Center for ADR Monitoring issued a notice “Issues on Implementation of Periodic Risk Assessment Reports for Medical Device Adverse Events”. This notice is used to provide a rough idea to the MAHs (market authorization holders) to identify what kind of information shall be included 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.

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 NMPA certified legal representative. We can help you fulfill the pre and post market legal agent requirements without your need to setup 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 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.