A Periodic Risk Evaluation Report (PRER) 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.
We developed this Q&A to address the common issues arouse from manufacturers that are drafting Periodic Risk Evaluation Report.
Q: For Class I device, a regular risk evaluation report is written every year in the first five years. If the product is cancelled in the fourth year, can it only be written until the fourth year?
A: If the product is still on market, it is recommended to write regular risk assessment reports.
Q: Regarding the periodic risk evaluation report, if a product was certified on November 23, 2018 and the modification registration was approved on September 3, 2018, the reporting period of the 2019 periodic report that needs to be supplemented is November 23, 2018 to November 22, 2019 or September 3, 2018 to November 2, 2019?
A: The summary time of this supplementary report shall be from November 23, 2018 to November 22, 2019, based on the original certificate.
Q: The periodic risk evaluation report for products in the first registration cycle is written once a year, and the start date (month, day) of the data collection is consistent with the time when the approved registration documents are obtained. If I registered in May 2016, do I need to supplement the reports for 2016-2017 and 2017-2018, or just supplement the reports for 2019 and 2020?
A: Only report of 2019 and 2020 should be supplemented.
Q: An imported product was first registered in 2015 and expired in 2020. If the registration is not renewed, do I need to submit a periodic risk evaluation report? If the product has been discontinued and no manufacturer can be found, how to write a regular risk assessment report?
A: For products that do not seek renewal, companies shall ask the original manufacturers write a regular risk assessment report; and those who cannot find original manufacturers, a description of the situation should be submitted.
Q: The product has not been sold after obtaining the registration certificate (the previous national sampling also indicated that there is no sample). Is it necessary to submit a periodic risk assessment report?
A: It should be written, with the information of foreign adverse event analysis, measures taken, and literature analysis. If any information is missing, a description of situation shall be submitted.
Q: Regarding Article 3.2.2 of the regular risk evaluation drafting specification, the relevant requirements put forward when the product is approved for marketing, especially the requirements related to risk control. Article 3.2.2 is the Design Failure Mode & Effects Analysis (DFMEA)?
A: Article 3.2.2 refers to the requirements related to risk control raised when the registration is approved, which may be related to DFEMA. However this part is only summary information instead of analysis.