Document Retention Policy for NMPA

bill.Kal

Involved In Discussions
hi Medtech Community,
Who can help me retrieve the following in info?
  1. What is the document retention policy when submitting documentation to launch a medical device in China?
  2. Is there a difference for clinical investigations?
Thank you for your help!
 

TimZhao

NMPAFocus
  1. What is the document retention policy when submitting documentation to launch a medical device in China?
    keep the same retention with your product(s) shelf life
  2. Is there a difference for clinical investigations?
    according to MDs clinical trial quality management standard (No. 28,2022)
    (1) Researchers shall properly keep the basic documents of clinical trials during the clinical trials of medical devices;
    (2) The medical device clinical trial institution shall keep the basic clinical trial documents after the completion or 10 years after termination of the medical device clinical trial;
    (3) The ethics committee shall keep all records of the ethical review after the completion or 10 years after termination of the clinical trial of the medical device;
    (4) The applicant shall keep the basic clinical trial documents until the medical device is not use
 
Top Bottom