Chapter III Reporting and Evaluation
Section I Basic Requirements
Article 17 The reporting of medical device adverse event shall adhere to the principle of “when in doubt-report”, that is, an event can be reported as a medical device adverse event once it is suspected to be so.
The reported information shall be true, complete and accurate.
Article 18 Suspicious medical device adverse events that cause or may cause serious injury or death shall be reported; for innovative medical devices, all medical device adverse events of the product during the first registration period shall be reported.