New NMPA Guidelines on Periodic Risk Evaluation Reports (PRER) for Medical Device Adverse Events

On July 2, the NMPA (National Medical Products Administration) released the updated guidance document for preparing the periodic risk evaluation report for medical devices addressing the timescale and data collection scope for preparing and submitting the initial report:

• For medical devices in their first registration / filing cycle, the registrant should complete and submit the periodic risk evaluation report within 60 days after each full year.

• The periodic risk evaluation report of Class II and Class III medical devices should be submitted online via the NMPA adverse event reporting system

• The period risk evaluation report of Class I medical devices should be prepared annually for the first five years, and should only be submitted when required. The preparation of annual reports can be omitted after 5 years.

• For medical devices whose specifications were registered in different certificates (e.g. different specifications of disposable sterile syringes) or medical devices that must be used together with other devices under a different registration certificate (e.g. hip systems which include acetabular cups, femoral stems, etc.), the risk assessments can be incorporated into one report, but should be submitted before the earliest deadline. The registrant should include any related information of the medical devices upon the submission or archiving of the report. If the registrants intend to incorporate the risk assessments into one report for medical devices of the same kind, they should conduct a subgroup analysis based on the registration certificate number.

By Jacky Li. Contact Cisema to learn more.