Zhejiang LongYouXian "4 - a strengthening" to medical equipment enterprise launched special inspection

Medical equipment webex in recent years, with the continuous development of medical devices industry, medical apparatus and instruments in the supervision of the more important. It is reported, in order to strengthen the standard medical equipment market order, to ensure that people use machinery is safe and effective, and recent LongYouXian in zhejiang, the administration's special to adopt a "4 - a strengthening" strong measures, the medical equipment market many wholesale enterprise launched special supervision and management. One is to prevent overspray business. Carefully check the enterprise certificate and business catalog, and requests the enterprise within the approved business scope, the root according to actual operation in accordance with the prescribed procedures, deal with relevant formalities, put an end to the change of management behavior overspray.

The second is prevent illegal marketing channels. Check the enterprise supplier and purchase FangZi mass materials, current standing book, inventory situation and related products bill (along with the goods pass line single), requests the enterprise to the supplier and purchase party qualification and filing work.

Three is the anti reduce operating conditions. The enterprise management place, warehouse site, check the equipment operation, check whether keep declaration of conditions, to ensure the enterprise does not occur without the change of behavior.

Four is the anti basic parameter is not sound. Check enterprise marketing save standing book content, clear enterprise to the pin product varieties, specifications, batch number, place of origin, purchase unit, sold to units, product registration number and other detailed information registration, easy to trace and quality tracking, ensure quality and safety.

Five is to strengthen the long-term management. Establish and perfect the enterprise supervision archives, the on-site inspection situation detailed record and file. Stable cross medical instrument laws and regulations, guide enterprise around the quality management system for quality management, to carry out medical device adverse event monitoring and reporting work, guide enterprise benign operation.