www.fdanews.com/articles/188227-china-simplifies-device-registration-requirements
China Simplifies Device Registration Requirements
August 30, 2018
China’s State Drug Administration is loosening some documentation requirements for device registration renewals to simplify compliance.
According to a recent SDA notice, only summary information will be required for device and IVD renewals, and devicemakers will no longer need to submit sales data, and post-market inspection reports.
However, devicemakers should continue to report adverse events and complaints as these requirements have not been relaxed.