Periodic Risk Evaluation Reports for Medical Device Adverse Events – New Guidelines Issued

On 06.05.2020, the NMPA (National Medical Products Administration) provided important details on the ongoing reporting requirements for NMPA-registered medical devices (including IVDs). The NMPA’s medical device supervision department, the National Center for Adverse Drug Reaction (ADR) Monitoring, has explained the timescale and data collection scope for preparing and submitting the initial periodic evaluation report for medical devices according to the Administrative Measures on the Monitoring and Re-evaluation of Medical Device Adverse Events (Order No. 1 of the General Administration of Market Supervision and Administration) (abbr. as “the Measures”):

1. Class II and Class III medical device registrants should submit periodic risk evaluation reports for 2020 following the requirements of the Measures. If the due date is earlier than 30/09/2020, the registrants should submit the report before 30/09/2020.
2. For class II and class III medical devices that are in the first registration cycle on 01/01/2019, the registrant should also submit the 2019 annual risk evaluation report before 30/09/2020.
3. For medical devices in their first registration cycle, the registrant should submit a periodic risk evaluation report annually. The data collection start date should be consistent with the date on the registration certificate.
4. Class I medical device registrants should submit a periodic risk evaluation report annually in the first five years after obtaining the filing certificate. But there is no need to write the reports afterward.
5. For medical devices whose specifications were registered in different certificates (e.g. different specifications of disposable sterile syringes) or medical devices that must be used together with other devices under a different registration certificate (e.g. hip systems which include acetabular cups, femoral stems, etc.) can incorporate the risk assessments in one report and submit it before the earliest deadline. The registrant should indicate the information of related medical devices upon report submission or archiving. For medical devices of the same kind, the registrant intended to incorporate the risk assessments in one report, they should conduct a subgroup analysis based on the registration certificate number.

The English version is for reference only. In case of any discrepancy or ambiguity of meaning between this English translation and the Chinese version, the latter shall prevail.

This new reporting requirement is consistent with the NMPA’s push for continuous post-market surveillance. Since 2018, post market compliance, adverse event and annual reporting regulations are increasingly strict. It is important for companies with registered devices to be vigilant with their ongoing requirements and not take a “set-and-forget” approach. The role of NMPA Legal Agent is therefore increasingly important.

Cisema has 11 offices worldwide, five of which are in China. We can represent manufacturers as their NMPA Legal Agent for the complete product life cycle without their need to create a local entity in China. Contact us to talk through your particular requirements.

Read the Chinese version here.

By Jacky Li. Contact Cisema to learn more.