Administrative measures on registration and filing of medical devices (hereinafter referred to as “Administrative Measures”)

Adjustment Purpose	Adjustment Measures	Rules of Management Measures
Fully implement the system of medical device registrants and filers	The main responsibility of medical device registrants and filers shall strengthen the quality management of the whole life cycle of medical devices, and take responsibility for the safety, effectiveness and quality controllability of medical devices in the whole process of development, production, operation and use according to law.	Article 9 of the Administrative Measures
Implied permission for clinical trials	Within 60 working days from the date of acceptance and payment of the application for examination and approval of clinical trials, if the applicant has not received the opinions of the device examination center (including the notice of expert consultation meeting and the notice of supplementary information) on the premise that the reserved contact information and mailing address are valid, the applicant can carry out clinical trials.	Article 40 of the Administrative Measures
Extended clinical trials	Medical devices that are undergoing clinical trials for the treatment of diseases that are serious y life-threatening and have no effective treatment means may benefit patients after medical observation. After ethical review and informed consent, they can be used for other patients with the same condition free of charge in institutions that conduct clinical trials of medical devices, and their safety data can be used for medicaldevice registration applications.	Article 46 of the Administrative Measures
Condition approval regulations	For the treatment of rare diseases, serious life-threatening diseases without effective treatment means, and urgently needed medical devices such as responding to public health events, the drug supervision and administration department may make a conditional approval decision, and specify in the medical device registration certificate the validity period, the research work to be completed after listing ,the completion time limit and other related matters.	Article 61 of the Administrative Measures

Post time: Oct-15-2021