What is Medical Device Registration

What is Medical Device Registration

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to decide whether to approve their sale and use. It is divided into domestic medical device registration and overseas medical device registration. Overseas medical devices, whether they are Class I, Class II, or Class III, must be handled by the State Food and Drug Administration in Beijing: domestic Class I and Class II medical devices are registered in the local province Or the Municipal Food and Drug Administration, and the third category to the State Food and Drug Administration. Medical device registration certificate refers to the legal ID card of medical device products.