The principle of suspicious reporting refers to reporting as a suspicious medical device adverse event when it is not clear whether it is a medical device adverse event. It is also a safety problem that some medical devices fail to achieve the expected use effect. These incidents may be related to the use of medical devices and cannot be ruled out. The contents of the report shall be true, complete and accurate.

Suspected medical device adverse events that cause or may cause serious injury or death should be reported. All adverse medical device events of innovative medical devices should be reported within the first registration period. Common medical device adverse events include injury events and failure events.

The reporting, analysis and evaluation of medical device adverse events are all completed through the network platform (new system), which requires users, holders and business enterprises to register accounts, maintain information and carry out adverse event monitoring in the new system. Medical instruments include medical equipment and medical consumables.

Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software. Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these methods are involved, they only play an auxiliary role.

Common types of medical equipment:

The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.

The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.

The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.