On August 31, 2018, the official website of the National Medical Products Administration issued the “Administrative Measures for Monitoring and Re-evaluation of Medical Device Adverse Events” (State Administration for Market Regulation Order No. 1) (hereinafter referred to as the “Measures”). The Measures put forward a series of new work requirements for medical device registrants, including writing regular risk assessment reports for post-market medical devices. According to the “Main Obligations of Holders” in Article 14 of Chapter 2 of the “Measures”, holders should establish systems, allocate personnel and institutions, report adverse events, control risks, release information, write regular risk assessments report, re-evaluate, and cooperate with investigations. Even if no adverse events occur, regular risk assessment reports still need to be submitted regularly and on time. Adverse event reports are part of the regular risk assessment reports, but not the entire content. Monitoring data is the summary and analysis of domestic and foreign risk information. We can assist you in writing this report.

Main Requirements

  1. Writing cycle of periodic risk assessment report:

    • After initial registration or filing, it should be written once a year;
    • After renewal of registration, it should be written once every five years.

  2. Safety information requirements during the reporting period:

    It should be continuous, no omissions, and no duplication.

  3. Requirements for evaluation content:

    • Summary of risk information;
    • Analysis of adverse event monitoring information;
    • Synthesis of other risk information;
    • Evaluation of post-marketing risks: Whether the risk has changed and whether it is acceptable?

  4. Overall requirements for the report:

    • complete and standardized;
    • have a logical structure (introduction, data, analysis, conclusion);
    • identifiable (date, version, registrant and contact person, etc.).

Time Frame

  • The data aggregation period is consistent with the time of the registration certificate: if the certification date of a product is August 10, 2018, then the data aggregation period of the periodic risk assessment report that needs to be submitted in 2019 is August 10, 2018 to August 9, 2019.
  • The data aggregation period for the current report of products that have been extended registration in advance is still calculated based on the first registration period: For example, if the registration certificate of a product expires on August 30, 2020, but it obtained the renewal registration certificate in May 2020, for this product, the current report will still use August 30, 2020 as the end date of the summary period.

Precautions

  • For Class Ⅱ and Class Ⅲ products registered for the first time, after submitting information online, it will be reviewed by the National Medical Products Administration or the Provincial Medical Products Administration according to different approval agencies. The review results can be checked online;
  • For products with renewal registration and filing, there is no requirement to submit periodic risk assessment reports online. Once completed writing, the reports can be retained for future reference. However, they must be included in the monitoring data for standardization and preservation.

      Monitoring adverse events of medical device products and regularly analyzing product risks is one of the important ways to ensure product safety. Therefore, when writing a periodic risk assessment report, the registrant should write a risk analysis from two aspects: risk identification and cause analysis, and evaluate its impact on security. Identifying risks includes the following:

  • Analysis of the characteristics, frequency, severity of injuries, etc. of adverse events;
  • Cause analysis should consider: design, production management, circulation and storage, usage factors, etc.

            In the conclusion section of the text, the registrant should indicate:

      1. Point out the differences in risk analysis results between this report and previous reports;
      2. Indicate the acceptability of the above risk differences;
      3. Summarize the risk control measures taken.

      Q&A About Periodic Risk Assessment Report of Medical Devices

      Q1: If the product is in the first registration period and stops production and sales after having sales activities, is it still necessary to continue to submit periodic risk assessment reports?

      A1: Yes, it needs. Even if production and sales have been stopped, the product may still be in circulation on the market. Therefore, in order to ensure that the risks of the product are controllable, periodic risk assessment reports still need to be submitted regularly and on time.

      Q2: Is it necessary to submit periodic risk assessment reports for products that have never been put on the market after obtaining the registration certificate?

      A2: Yes, it needs. When submitting a periodic risk assessment report within the system, a brief explanation can be provided in the body of the report, or the company can submit a statement that “this product has never been launched domestically or overseas” to replace the body of the report.

      Q3: Do emergency registered products need to submit periodic risk assessment reports?

      A3: Not needed yet. However, after emergency registered products are converted into officially registered products, periodic risk assessment reports must be submitted in accordance with the requirements of the first registration period. At the same time, the data aggregation period of the first evaluation report should cover its emergency registration period.