Medical device registration certificate.
1. Refers to the drug regulatory department, based on the application of the medical device registration applicant and in accordance with legal procedures, to conduct a systematic evaluation of the safety and effectiveness research and results of the medical device to be put on the market to decide whether to agree. its application process. Medical device registrants and filers should strengthen the quality management of the entire life cycle of medical devices and assume responsibility for the safety and effectiveness of medical devices throughout the entire process of development, production, operation, and use in accordance with the law.