The newly amended “Regulation on the Supervision and Administration of Medical Devices” (“Regulations”, 医疗器械监督管理条例) was passed on 9 Feb. 2021 and came into force on 1 June 2021. The Regulation applies to the research and development, production, operation, and use of medical devices within the territory of China, as well as the supervision and administration of medical devices.
One of the core revisions is to establish a medical device registrant system. Pursuant to the system, the medical device registrant is the “producer” of the medical device product, and is responsible for the safety and effectiveness of the medical device during the whole process of research, production, operation, and use in accordance with law.
In addition, the Regulation requires medical device registrants and record holders to establish a medical device adverse event monitoring system, take the initiative to reevaluate the registered medical devices, and take applicable risk control measures in accordance with the reevaluation results.
The Regulation also strengthens the administrative penalties, stipulating penalties for medical device registrants and record holders who fail to fulfill their obligations, as well as penalties for operators of online e-commerce platforms for medical device transactions who fail to fulfill their obligations.