The Medical Device Supervision Department of the Provincial Bureau conducted supervision and inspection on the implementation of the "Medical Device Operation Quality Management Standards" for some enterprises
Recently, the Medical Device Supervision Department of the Provincial Bureau adopted a cross inspection method to supervise and inspect the implementation of the "Medical Device Operation Quality Management Standards" (hereinafter referred to as the "Standards") by 72 medical device operating enterprises in the province. The object of this inspection is the second and third category medical device products operated by enterprises, with a focus on in vitro diagnostic reagents, sterile and implantable products. From the inspection results, it can be seen that most enterprises have formulated medical device operation quality management systems in accordance with the requirements of the "Regulations" and organized their implementation. However, there are still many problems, mainly manifested as: some enterprise quality managers cannot independently fulfill their responsibilities, the content of the quality management system is incomplete, and it cannot cover the entire process of enterprise operation; Not equipped with facilities and equipment that are suitable for the scope and scale of business, especially insufficient verification of storage and transportation equipment such as cold storage and refrigeration insulation, and computer information management systems that cannot * include quality control functions for all aspects of operation; The record content is incomplete, the after-sales service capability is lacking, and the monitoring of adverse events of medical devices has not been carried out seriously.
In response to the existing problems, the Medical Device Supervision Department of the Provincial Bureau requires all municipal bureaus to carry out rectification and review work to ensure that enterprises have rectified properly. Taking the special inspection as an opportunity, they should draw lessons from it and promptly identify common problems encountered by medical device operating enterprises in their jurisdiction during the implementation of the "Standards"; Strengthen supervision and inspection, conduct in-depth training and guidance, urge enterprises to establish a quality management system covering the entire operation process in accordance with the requirements of the "Regulations", and ensure product quality and safety in the operation process;

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