China’s Food and Drug Administration (CFDA) announced on October 8, 2013 that it would expand its monitoring network for medical device adverse events through the end of 2015. By that time, all provincial FDAs must have teams dedicated to investigating and reporting on medical device adverse events. In cases in which provincial FDAs must establish new teams, the national FDA will provide technical guidance.
The new teams will be responsible for improving the adverse events monitoring network, from data collection to information dissemination. In addition, provincial FDAs will be responsible for establishing early warning systems and strengthening the early evaluation of sudden or large group adverse events.
Under the expanded network, medical device adverse events monitoring teams will have jurisdiction over all Class 3 medical device manufacturers and most Class 3 medical device distributors. They will also monitor all hospitals and healthcare facilities that sell or use Class 2 and Class 3 medical devices.