NMPA issued NEW Guidance ON PERIODIC RISK EVALUATION REPORTS OF MEDICAL DEVICE

On July 2, NMPA released the updated guidanceofperiodic risk evaluation report for medical devices addressing the timescale and data collection scope for preparing and submitting the initial report:

• For th efirst registration orfiling cycle of medical devices, the registrant should complete and submit the periodic risk evaluation report within 60 calendar days after each year.
• The periodic risk evaluation report of Class II and Class III medical devices should be submitted online by 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 the medical devicesregistered in different certificates (e.g. different specifications of disposable sterile syringes) or medical devices that must be used combiningwith 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 singlereport, 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.