Medical device products on the market after the management and control of medical devices and what are the main measures and means?

Medical device products on the market after the main measures and means of management and control of medical devices are mainly the following:

One is the implementation of medical device adverse event monitoring system, is conducive to early warning and prevention of product risk. The second is to carry out medical device re-evaluation, is conducive to the control of medical device products after the market risk. Third, the establishment of medical device recall system, is conducive to protect the public safety of devices.

Introduction:

Medical devices refer to 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. Efficacy is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or although these means are involved but only in an ancillary manner.

The above references? Baidu Encyclopedia - Medical Device Supervision and Administration Regulations