In order to strengthen the supervision and management of high-risk medical devices, the Food and Drug Administration of Linyi City will conduct flight inspections on the key regulatory medical device production and operation enterprises and users in the city from now on. There are three key points in the flight inspection. The first is the acquisition of the relevant licenses of the production enterprises, the changes of the quality management personnel, the production process, the production inspection facilities and equipment, the changes of the main raw materials, whether the procurement, production management and quality control are in compliance. New version of the specification requirements. Followed by the relevant licenses of the operating enterprises, quality management personnel, after-sales service personnel changes and collection of adverse events, personnel training, health records, enterprise warehouse temperature and humidity control, refrigeration and refrigeration facilities equipment operation, product ticket claims, purchase Whether the acceptance record and the quality management of the operation meet the requirements of the new version of the specification. Finally, the use of the unit's purchase record, the qualification of the deposited supplier and the medical device's certificate of conformity, etc., long-term use of large medical device use files and use, maintenance records, personnel training, health files, warehouse temperature and humidity control, Operation of refrigeration and refrigeration facilities, self-inspection reports on quality management of medical devices, and monitoring of adverse events. The flight inspection lasted for one week and ended on June 6. In the flight inspection, the flight inspector is required to objectively reflect the on-site inspection situation, truthfully record the defect item, and fairly evaluate the inspected enterprise. The general defect items found in the flight inspection shall be ordered to be rectified within a time limit, and the relevant county and district bureaus shall follow up the implementation of the rectification and supervise the rectification of the project. Related Links What is flight inspection? The flight inspection was first applied to the inspection of stimulants in sports competitions, referring to unannounced surprise stimulant sampling during non-competition. In 1991, the International Olympic Committee adopted a bill specifically to establish an off-site inspection committee under its medical committee. Due to the unique suddenness and shock of flight inspection, it has become the killer of anti-doping in sports. As an effective means of supervision, this form of flight inspection was quickly extended to other certification units. Strengthen relevant testing capabilities and supervision and management in the government's key concerns and social hotspots. The focus of the inspection is on areas such as personal safety, food safety, energy conservation, and environmental protection. In 2006, China's State Food and Drug Administration issued the Interim Provisions on the GMP Flight Inspection of Drugs, and established a flight inspection system, which means that it does not notify the company under inspection and conducts rapid on-site inspections. femal swimming crab with red roe Swimming Crab Red Roe,Female Swimming Crab,Fresh Female Swimming Crab,Swimming Crab With Red Roe Zhoushan Junwei Aquatic Products Co., Ltd. , https://www.junweiaquatic-intl.com
Linyi conducts flight inspections on key medical device users