FAQs on the Review of Periodic Risk Assessment Report of Medical Devices

1. What is the need to write a periodic risk assessment report for medical devices?

For the medical devices approved for registration or filing for the first time, the regular risk assessment report of the product of the previous year shall be completed within 60 days after each full year. The regular risk assessment report of class I medical devices shall be kept by the filer for future reference.For the medical devices that have obtained the renewal registration, the registrant shall complete the regular risk assessment report of this registration cycle at the next application for renewal registration,and keep it for future reference. If the product is not produced and sold during the monitoring period, or the product has been cancelled but is still in circulation, it is also necessary to write a regular risk  report.

2. What should be written in the regular risk assessment report?

The regular risk assessment report shall summarize and analyze the basic information of the product, the listing at home and abroad, the risk control measures taken in the past, monitoring data and other risk information, and evaluate the risks and benefits of the product. Refer to the code for writing regular risk assessment of medical devices (hereinafter referred to as the code) issued by the State Food and drug administration https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200702155401886.html 。

3. How to modify the periodic risk assessment report if it is returned after review?

First, please check whether the following contents meet the requirements: The cover of the report shall be stamped with the official seal of the enterprise; If the scope of monitoring period is not filled in accurately, it can be set according to the reference range given by the monitoring information system; Individual adverse event reports failed to pass the audit and evaluation; Failing to write the catalogue and relevant contents according to the requirements of the Specification; Other risk information is not collected comprehensively; Failure to carry out risk analysis item by item according to the requirements of the Specifi-cation; The attachments of the report do not meet the requirements.

4. What are the common problems in report review?？

(1) The returned opinions are the source of adverse events, there are no supplementary complaints, literature and research projects, and the summary part of adverse events only has monitoring system data;

(2) Other risk information is not collected regularly and comprehensively. If the National Bureau or local regulatory authorities release the adverse events of similar products, the enterprise shall check its products to see if there are similar situations and make records. The report shall specify the risk data retrieval process and screening conditions;

(3) If the risk analysis is not carried out as required, the holder shall clarify all known risks of specific products. Refer to YY / T 0316-2016 application of medical device risk management to medical devices, and carry out risk analysis item by item according to the requirements of the specification in combination with complaints, risk information and adverse event reports after the product is put on the market;

(4) If the data has authenticity problems, the person in charge of enterprise monitoring shall carefully check the contents of the report to avoid data errors and typos as much as possible.

     5. What are the legal liabilities for failing to write the periodic risk assessment report of medical devices as required?

According to Article 67 of the measures for the administration of adverse event monitoring and re evaluation of medical devices (Order No. 1 of the State Administration of market supervision), if the holder fails to collect product safety information through adverse event monitoring as required, or fails to carry out post marketing research and re evaluation as required, which cannot ensure the safety and effectiveness of the product, the drug regulatory department shall carry out key inspection on the holder. And Article 73 If the holder fails to write, submit or retain the regular post listing risk assessment report as required, the drug regulatory department at or above the county level shall order it to make corrections and give a warning; Those who refuse to make corrections shall be fined not less than 5000 yuan but not more than 20000 yuan. According to theInspection Points for Medical Device Registrants and Recorders to Carry Out Adverse Event Monitoring, if the writing of regular risk assessment report of medical devices does not meet the relevant requirements of the Specification during the inspection of quality management system, special inspection of adverse event monitoring and daily supervision and inspection, it is considered that the inspection items of “design and development” may have defects.

Source: Jiangsu ADR Monitoring Center

Edited and translated by ：BradyKnows

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