In order to strengthen the supervision of medical device manufacturing enterprises, the company urges enterprises to establish a production quality management system based on the "Quality Management Standards for Medical Device Production" and maintain effective operation, further improve the quality management level of production enterprises, ensure the safety and effectiveness of medical devices after listing, and save food and drug supervision and management. In recent days, the bureau has carried out special inspections on the third category of medical device production quality management regulations.
Highlights of the inspection:
Whether the quality management system of the production enterprise maintains effective operation in accordance with the "Quality Management Standards for Medical Device Production";
Whether the production conditions continue to meet the statutory requirements;
Whether to organize production and release according to the technical requirements of product registration; whether the product structure, main raw and auxiliary materials (components), production process and risk management and control measures are consistent with the contents of product registration and approval;
Whether the random documents such as product specifications, packaging and labeling are consistent with the contents approved by the registration certificate;
The whole process risk management of high-risk medical device products (three types of products listed as key regulated varieties).
A total of 27 three types of production enterprises were inspected, 78 inspectors were dispatched, 13 were rectified and rectified, and one was being cancelled.
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