Medical Device Adverse Event Monitoring and Re-evaluation Management Measures was considered and adopted by the State Administration of Market Supervision and Administration and the National Health and Health Commission, aiming to strengthen the monitoring and reevaluation of adverse events of medical devices, published on August 13, 2018, *** nine chapters and eighty articles, since January 1, 2019 shall come into force.
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 supplies.