China Issues New Device Guidance on Real World Evidence

Real World Data can bolster medical device registration applications in China, even though it cannot be utilized as the only clinical evidence source for product registrations. Recently, the NMPA presented a document to gather public feedback on – the Guidelines for Registration Review of Real World Designs and Statistical Analysis for Medical Devices. This draft document includes different elements on real-world evidence such as what should be considered in project blueprints, how should statistical analysis be done, etc.

Real-world evidence can be gained and utilized via the Hainan Pilot Zone on Hainan Island. This zone was set up to help facilitate urgent medical needs. Overseas products that have not been approved in China yet can apply via the urgent need medical process. Patients can come from different parts of China to access the unregistered medical products. In some cases, China’s real-world evidence can be used to support your Western device applications too.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.