Leaders discussed the Real World Data (RWD) Pilot Program — a cost-effective and less time-consuming alternative to the traditional clinical trial — at a meeting in Boao, Hainan Province. China’s NMPA (CFDA) hosted the meeting on October 10-11, joined by National and Hainan Provincial NMPA officials and eight overseas manufacturers, including one represented by China Med Device.
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.
Certain protocols and guidelines need to be followed for the Real World Data to be admitted as part of the clinical evidence for submission. The China Med Device client who participated in this pilot program will benefit from this new policy.
First in China
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.
RWD is the second major policy incentive for overseas manufacturers going into Hainan. The first is the status of ‘first independent province for imported medical device approval’. “Imported medical devices can be clinically used in Boao City, Hainan province without national NMPA registration approval, as long as they are approved by Hainan Province NMPA office”, announced by China State Council on April 4, 2018.
To qualify if your devices fall into Real World Data category, please email info@ChinaMedDevice.com.
For a chart showing the China registration and clinical trial process, please email us also.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory, CRO and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) agent with offices in Boston and Beijing, CMD can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA regulatory and clinical services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, overseas clinical data acceptance, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.