Regulatory Open Forum

NMPA issued the "Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)" on December 13, 2019. Feedbacks need to be submitted by January 13, 2020.

Full List of Applicable Scenarios

The document describes eleven situations that RWD can be used in China:

1. To be used in Clinical Evidence Report (CER) for comparison of same type products;
2. To be used with existing clinical evidence to support product registration;
3. The RWD generated from the permitted use of clinically-needed medical devices in China can be used as supplementary data to support product registration;
4. Used as the external control for single group experiment;
5. To provide clinical data for the establishment of single-arm objective performance criteria;
6. To support modification of Scope of Application and Intended Use;
7. To support modification of clinical claims in package insert
8. To support post-market studies on products which are granted Conditional Approval;
9. To be used for the evaluation on long-term safety and efficacy of high-risk implants or similar medical devices;
10. To be used for clinical evaluation of medical device for treatments of rare disease throughout the full Life Cycle to expedite the product registration;
11. Used as Post-Market Surveillance.

Another Clinical Pathway

Real World Data will become another 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.

Hainan is the first province to pilot Real World Data in China. It offers an additional clinical option to the currently available clinical pathways such as clinical evaluation report and overseas clinical data acceptance. As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China. Certain protocols and guidelines need to be followed for the RWD to be admitted as part of the clinical evidence for submission.

Eight overseas manufacturers participated in the Hainan RWD program piloted since June 2019, including one represented by us. To determine if your devices & IVDs fall into the RWD catalog, please leave your comments here or email me at gpalma@ChinaMedDevice.com. We have also translated the "Guideline on Real World Data Used in Medical Device Clinical Evaluation (Draft)" and other official NMPA documents into English as a service for our clients.

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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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