A New Clinical Pathway for China Registration
New drugs and devices that have been approved overseas but have not been marketed in China can be licensed for import in the Hainan Boao Medical Pilot Zone, and patients can apply and use them through Real-World Data program.Real-World Data will become a major clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program through Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval. This is especially significant for manufacturers with high price tags, as RWD program participants can generate clinical data in the actual clinical environment with service fees whereas the traditional clinical trial needs to be complimentary.
Certain protocols and guidelines need to be followed for the Real-World Data to be admitted as part of the clinical evidence for submission.
What Is the Scope for RWD in China?
On December 13, 2019, NMPA issued the “Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft).” The document specifies the sources of RWD as following:
- Data derived from electronic health records (EHRs)
- Medical claims and billing data
- Data from product and disease registries
- t-generated data, including from in-home-use settings
- Data gathered from other sources that can inform on health status, such as mobile devices.
- Data generated from the complete life cycle of the medical device: production, sales,
transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.
Eight overseas manufacturers participated in the Hainan RWD program piloted since June 2019, including one represented by China Med Device, LLC. To qualify if your devices fall into the Real World Data category, please email info@ChinaMedDevice.com.