Home » 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.
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