First, strict market access. Strictly put the medical device production enterprise start-up, license renewal site review, the second and third class medical device registration quality management system on-site assessment, the second and third medical device first registration to send samples to verify the authenticity of the level of non-compliance with the requirements of the enterprise and the product, resolutely not to be able to pass. The whole **** completed the medical device manufacturers review or assessment of 25 items, after review, rejected 1, ordered rectification and review of 2 items.
The second is to strengthen the daily supervision. Continue to strengthen the daily supervision of sterile medical device manufacturers, and steadily promote the implementation of the "norms" of the work. Organizations to carry out custom-made denture, medical electrical equipment
class of enterprises special inspection "look back", urging enterprises to rectify the problems, enhance the quality assurance capabilities of the relevant enterprises. Continuously strengthen the daily supervision of high-risk product enterprises, comprehensive analysis and assessment of the product of the various risk factors
and production process of the key risk points, urging enterprises to take appropriate measures in all aspects of the production process, as far as possible to eliminate or reduce the risk. Throughout the year *** on 66 production enterprises to carry out 88 times of daily supervision and inspection, inspection
After the case, the investigation and prosecution of one enterprise, ordered a deadline for rectification of five enterprises.
Third, strengthen the technical support. Continue in the daily supervision of the product supervision and testing, the area of enterprise production of suture needles with thread, disposable anesthesia puncture kits, extracorporeal circulation blood circuit, a
sexual use of infusion products such as supervision and sampling, and sampling of products commissioned by the Zhejiang Provincial Institute of Medical Devices Inspection inspection and testing, to find the existence of the product of the substantive issues, improve the scientific nature of the day-to-day supervision of the enterprise;
Fourth, strengthen the training of personnel. p> Fourth, strengthen personnel training. Relying on the city of medical device industry associations, organizations to participate in the "production quality management standard for medical devices" training, to improve the understanding of the "norms" of the relevant enterprises; invited
City Institute of Pharmaceutical Inspection of biological testing experts on the aseptic enterprise inspectors aseptic test operation training, to help enterprises to develop a detailed aseptic test of the product operating procedures, to improve the level of inspection of the enterprise's products;
Fifth, to promote the integrity of the construction. Through the clear evaluation object, unified evaluation standard, strengthen the evaluation information collection and other measures to ensure the fairness and impartiality of enterprise quality credit rating; according to the principle of strain regulation
, appropriately increase the frequency of daily inspection of enterprises with low quality credit rating; incorporate the information of enterprise quality credit rating into the scoring standard of the district government's bidding for medical devices, and encourage medical institutions to purchase medical equipment from enterprises with high quality credit rating. Procurement
Medical devices.