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China PRER Due September 30, 2020: More Info to Help (I)


A Periodic Risk Evaluation 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 Evaluation Report. Email 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: Regarding the drafting of Appendix 3 “Summary of Domestic and Foreign Approval Status”. For renewal of the registration certificate, is it necessary to fill out the historical registration information?

A: Only the information of current registration cycle should be filled out. The renewal of registration should be described in the Product Information.

Q: If the renewal registration has been completed when the first registration certificate is written for the final year’s periodic risk evaluation report, can I write the information of the renewal registration certificate into the periodic risk assessment report?

A: Yes, you can. And the summary time must be consistent with the validity period of the first registration certificate.

Q: Regarding the drafting of Annex 4 “List of Individual Cases of Adverse Events”, the report code needs to be filled in the list. Is it necessary to fill in only the adverse event reports that have been reported in the national system? If there is no adverse event report reported in the national system, do I need to fill in it? Do I need to summarize overseas “other events”?

A: It is necessary to fill in all the adverse events of this reporting period, not limited to the domestic and foreign adverse events in the national adverse event monitoring information system, but also include reports collected spontaneously by the enterprise or obtained through other channels. If it is not reported in the National Medical Device Adverse Event Monitoring Information System, the report code and relevance evaluation can be left blank. foreign “other events” should be on the adverse events report.

Q: Our company’s products were registered for the first time in August 2012 and changed in November 2016. The content of the change is to add a model to the registration certificate (the original registration certificate has one model, and one model is added after the change. There are two models on the current registration certificate), do we need to submit periodic risk assessment reports in the National Medical Device Adverse Event Monitoring Information System? Or should it be completed at the time of renewal application and kept for future reference?

A: It is recommended to deal with the new certificate and submit a regular risk evaluation report.

Q: Regarding the domestic and international market situation, “main country and region and time for obtaining marketing authorization”, what time do I need to fill in?

A: Both the approval time of the current foreign registration cycle and the first time the product goes to market need to be filled in.

Q: If the company sells similar products overseas, while the model is different from that in China, is it necessary to issue a statement and do a statistical analysis?

A: Not mandatory to issue a statement or do a statistical analysis.

Q: For the initial registration period of an innovative product, a summary report of the adverse event monitoring analysis and evaluation of the product to the national monitoring agency need to be submitted every six months. How should this report be submitted?

A: Regarding the submission of innovative product’s reports, the National Adverse Events Monitoring Center is currently preparing to communicate with the Supervision Department to study whether it can be submitted online through regular modules. At present, the companied can save it first, or send a paper version of the report to the center. In the future it may need to be submitted online.

Q: Regarding regulations for writing regular risk assessment reports 3.3, in the part of previous risk control measures, does the regular risk assessment report submitted by an import product agent only need to write domestic control measures during the reporting period?

A: The risk control measures for imported products are mainly taken by overseas manufacturers. Some are not implemented by import agents. Therefore, the risk control measures taken by overseas manufacturers and the risk control measures taken by domestic agents should be written, regardless of the risk control measures of overseas manufacturers. You can fill out the information whether it involves China or not.

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