Navigating the Muddy Waters of Chinese Device Regulations

Navigating the Muddy Waters of Chinese Device Regulations

April 25, 2016, International Devices & Diagnostics Monitor

John Balzano’s remarks from an FDAnews webinar are quoted extensively in this article on changes to Chinese device regulations. According to Balzano, it is important to consider a host of issues, such as whether the device will be manufactured in China. Understanding the finer points of the Chinese FDA guidances "can influence whether your application gets accepted or rejected at the filing stage, or whether the reviewers at the Center for Medical Device Evaluation are going to have to come back to you and ask you for supplementary materials" he said.