On November 26, 2020, the National Medical Products Administration (NMPA) issued technical guidelines (trial) for utilizing Real-World Data (RWD) in the medical device clinical evaluation process (No.77 – 2020).
The document covers the following 5 major topics:
- The definition of RWD and real-world evidence (RWE)
- The advantages and limitations of real-world studies (RWS)
- Common sources and quality evaluation of the RWD
- Common types of RWS designs and methods for statistical data analysis
- Common situations where RWD can be applied in the clinical evaluation process
In the guidelines, the NMPA further addressed 11 common situations, summarised below, where RWD is justified for the clinical evaluation of medical devices:
- Provide clinical evidence for the clinical evaluation report (CER)
- Utilize the collected RWE for the product registration
- Utilize the collected RWE for the registration of urgently needed medical devices that had previously been approved only temporarily
- Utilize RWE collected from historical data of comparable patient cases as an external control for single-arm trials
- Serve as data reference for setting performance targets in single-arm trials
- Utilize the collected RWD to update the scope of application, indications, and contraindications
- Support the modification of the clinical claim indicated in the instructions for use (IFU/user manual)
- Support post-marketing research for medical devices with conditional approval
- Support long-term safety and efficacy evaluation for high-risk implantable medical devices
- Utilized in the full life-cycle clinical evaluation of medical devices for the treatment of patients with rare diseases with shortened time to market
- Support post-market surveillance
At this stage, the RWD can only serve as supplementary information and cannot yet fully replace the existing clinical evaluation paths, such as clinical trial in China, clinical evaluation of overseas clinical trial data, CER based on predicate device.
This legislation represents a further step towards other global leading regulatory frameworks.
By Jacky Li. Contact Cisema if you would like to learn more.