Liaoning Provincial Drug Administration

Internal mechanism

Internal mechanism

Department of medical device supervision and Administration

  Master and analyze the medical device safety situation, existing problems, and put forward suggestions to improve the system mechanism and improve work,Handle the registration of relevant medical device products according to law,Implement classified management of medical device products according to law,To supervise the implementation of legal standards for medical devices, production quality management practices and clinical trials,To guide the implementation of business quality management standards and the use of quality management measures。Responsible for the on-site inspection of medical device development, undertake the supervision and inspection of production links, responsible for the investigation of illegal activities in the development and production links, organize and guide the on-site inspection of operation and use links and the investigation of illegal activities。Organize random inspection of medical device quality, and issue regular quality announcements。Organize the monitoring of medical device adverse events and handle them according to law。To be responsible for issuing the export certificate of medical device products and entrusting the production record, to be responsible for implementing the supervision and administration of imported medical device agents。

  Responsible person: Zhu Yanfeng  Office Phone:024-31602059

  Contact: Sun Xiaoling  Office Phone:024-31607043