OBJECTIVE: To improve the electromagnetic compatibility (EMC) quality of medical devices, improve the efficiency of EMC testing, and promote the speed of market approval. METHODS: The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed, and the reasons of low EMC quality of medical devices were analyzed from the perspective of test. RESULTS: Based on the analysis of the reasons, the suggestions were given from the perspectives of medical device manufacturers and testing organizations. CONCLUSIONS In order to ensure the quality of EMC of medical devices, medical device manufacturers, regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility, to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.
Electromagnetic Phenomena ; Industry ; Electromagnetic Fields