Announcement No. 77 of 2020 by the NMPA has featured technical guidelines on the application of real-world data in the clinical evaluation of medical devices and IVDs for registration in China. The guidance includes discussion of the advantages and limitations of real-world research, common real-world data sources, and evaluation of the quality of real-world data for inclusion in clinical evaluation.
Along with this announcement, there is also an interpretation of the technical guidelines to accompany this new guidance and further summarize and explain the related concepts.
Real-world data described in this Guideline refers to a variety of data collected from a variety of sources other than traditional clinical trials related to patient health and/or routine care and care.
The Guiding Principles require data quality from both relevance and reliability, and adopt the relevant contents of the IMDRF Medical Device Clinical Evaluation Working Group and IMDRF Registration Working Group Outcome Document, and put forward the specific considerations of data quality evaluation from six aspects: representativeness, completeness, accuracy, authenticity, consistency and repeatability, so as to improve the operability of quality evaluation.
Common situations in which real-world evidence can be considered for clinical evaluation of medical devices:
- 1) providing clinical evidence in the same clinical evaluation path
- 2) Used to support product registration as a supplement to available evidence
- 3) Real-world data generated by the urgent need for clinically imported instruments for domestic licensing can be used to support product registration as a supplement to existing evidence
- 4) As an external control of a single group of tests
- 5) Provide clinical data for the construction of a single set of target values
- 6) Support the modification of the scope of application, adaptive disorders and taboos
- 7) Support the modification of the clinical value of the product in the instruction manual
- 8) Support post-market research on products subject to conditional approval
- 9) Long-term safety and/or effectiveness assessment of medical devices such as high-risk implants
- 10) Clinical evaluation of the full life cycle of medical devices used to treat rare diseases, accelerate their listing process and meet the needs of patients
- 11) Post-market monitoring
From the above eleven common scenarios, it can be seen that in the current stage of development, real-world evidence in clinical evaluation of medical devices, act supplementary to existing clinical evidence, and can‘t replace the existing clinical evaluation path.