Q&A – Medical Device Risk Assessment

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?

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

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?

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

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”?

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.

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?

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

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?

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

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?

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

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?

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.

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?

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.

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?

If the product is still on market, it is recommended to write regular risk assessment reports.

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?

The summary time of this supplementary report shall be from November 23, 2018 to November 22, 2019, based on the original certificate.

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?

Only report of 2019 and 2020 should be supplemented.

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?

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.

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?

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.

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)?

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.