For Class II medical device business filing certificate, the requirements for personnel are as follows: the person in charge of quality is required to have college education or intermediate title or above, and more than three years of relevant quality management experience in related professions; other personnel, although there is no clear educational requirements, but it is recommended that secondary school or high school education or above.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.
Medical devices include medical equipment and medical consumables.