Real-World Data in NMPA Medical Device Clinical Evaluation

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 1

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 2

Core definition and value of real-world data

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 3

Real-world data (RWD) are data relating to patient health status and routine diagnosis, treatment and care collected from a variety of settings outside traditional clinical trials. Their core value lies in:

Supporting regulatory decisions: clinical evidence on device use and risks/benefits derived from analysis of RWD can be incorporated into regulatory review as a scientific basis.

Advantages as a research setting: conducted in real-world clinical practice, with broader patient inclusion criteria and larger sample sizes, it can capture long-term clinical outcomes and its results are more generalisable – especially suitable for observing rare serious adverse events.

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 4

The three core sources of real-world data

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 5

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 6

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 7

One chart: the real-world data application framework

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 8

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 9

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 10

Professional services from EVERBIZ

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices – Figure 11

As a technical service platform specialising in medical devices, Everbiz draws on many years of hands-on experience in quality systems and registration to offer industry clients:

Design of real-world data collection plans

Writing clinical evaluation reports and building the chain of evidence

End-to-end regulatory compliance guidance

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