Recently, in order to implement the relevant requirements of the new version of the “Measures for the Supervision and Administration of Medical Device Operation”, the Provincial Food and Drug Administration has adjusted and upgraded the functions of the original medical device information collection system, realizing the new version of the medical device business license. Certificates and filing certificates are issued, and data such as medical device business licenses, filings, and online sales filings of medical devices in the province are collected. The upgrade and improvement of the system will help the provincial bureau to grasp the basic situation of the medical device operating enterprises in the province, realize the “basic clearing” of the medical device operating supervision objects in the province, realize real-time push to the data sharing platform of the State Drug Administration, and apply it to Monitoring and comparison functions of medical device network sales enterprises.
This system upgrade also adds a medical device quality and safety hidden danger investigation and rectification module, which is used to dynamically collect and sort out the medical device production and operation inspection risk hidden danger investigation and rectification supervision work by means of information technology.
(Information Center of the Drug and Equipment Management Office)