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The Sichuan Provincial Drug Administration examined the results of the rectification of the "Medical Device Quality Management Standards" conducted by the State Administration

On December 28, 2020, the Sichuan Provincial Drug Administration organized experts visit company to address the personnel responsibilities such as the quality management system pointed out in the unannounced inspection by the inspection center of the State Drug Administration in November 2020., Document management, equipment management of general items do not meet the situation of rectification results to review.


The national flight inspection is mainly to inspect the quality management system of medical disposable protective clothing, with the purpose of continuously improving the level of the enterprise's medical device production quality management system. Regarding the general non-conformities raised by the National Bureau, we make great attention and implements immediate review and improvements.


The re-inspection experts on December 28 approved the rectification measures and the rectification situation, and the re-inspection result: passed the verification. (For details, please refer to: On-site Record Form of Rectification and Review of Medical Device Flight Inspection by the State Drug Administration).


As an enterprise approved to produce medical disposable protective clothing, we constantly promote the "Medical Device Quality Management Specification" and the ISO13485 quality management system to ensure product quality, the company must strengthen the study of laws, regulations and quality management systems, and strictly follow The "Regulations on the Supervision and Management of Medical Devices", the "Quality Management Regulations for Medical Device Production" and related laws and regulations require the organization of production, which lays a solid foundation for standardizing corporate management and creating excellent product quality.


We sincerely thank the experts of the Inspection Center of the State Food and Drug Administration for their valuable comments on our company's quality management system, which promoted the company's quality management work and greatly improved our company's quality management work. 


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Tel:+86-0838-5400686-802 | 0838-5403328


E-mail: sale@eupon.com

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