China Proposes Expanded Criteria, Increased Penalties for Device Recalls

China Proposes Expanded Criteria, Increased Penalties for Device Recalls

November 4, 2016, FDAnews

John Balzano participated in an FDAnews webinar and is quoted in an article regarding China FDA’s proposed expanded requirements for medical device recalls and higher fines for manufacturers that fail to issue recalls. According to Balzano, to be eligible for the accelerated pathway for breakthrough medical devices, the intellectual property for the device needs to be held in China, and the device needs to represent an improvement over existing technology.