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