Revised Regulations on Medical Devices To Take Effect in June

New Regulations on the Supervision and Administration of Medical Devices , recently revised and promulgated by the State Council (State Council Decree No. 739 [2021]), will take effect on 1 June 2021. Anyone on the mainland who engages in activities related to research and development, production or operation of medical devices, or their supervision and administration, must abide by these regulations.

China classifies and administers medical devices according to their level of risk. Class I medical devices are subject to record-filing requirements, while class II and class III devices are subject to product registration requirements. The new regulations require registrants or filing applicants to shoulder the responsibility for the safety and efficacy of medical devices by setting up and maintaining a quality management system, strengthening post-sales management of their products, and establishing a traceability and recall system.

Source: State Council ​​​​​​​