It is reported that in 2015 China's medical device market will have a scale of more than 300 billion yuan, and China's medical device industry development will present three characteristics of strict legal supervision, high technical barriers and huge market demand. A few days ago, the CFDA official website made a detailed analysis of the "Measures for the Supervision and Administration of Medical Device Management" (hereinafter referred to as the Medical Device GSP), which was recently released, and shared with readers. What is the general idea of ​​the revision of the management measures? The safety and effectiveness of medical devices are related to the lives and health of the people. The operation process of medical devices directly affects the quality and safety of products. As one of the supporting regulations of the "Regulations", the operation method mainly grasps the following four points in the overall concept of revision: First, adapt to the development direction of the medical device industry. It can adapt to the mode of the main circulation business, and can also adapt to the characterization requirements of the multi-business mode that has emerged and may develop in the future, and ensure the quality and safety of medical devices. The second is to meet the needs of medical device supervision work. Both strengthen the program specification and strengthen the entity specification. The third is to comply with the requirements of decentralization and decentralization. Strive to reflect and adapt to the needs of the reform of the administrative examination and approval system, simplify the licensing and filing procedures. The fourth is to increase the punishment for violations of laws and regulations. Further clarify the identification of illegal acts, investigate the illegal responsibilities, increase the amount of fines, and increase the cost of illegal activities. What is the revised principle of the business approach? The newly revised business approach reflects the following principles: The first is to adhere to the principle of classification management. The first type of medical equipment is not required to be licensed and filed, the second type of medical equipment is operated for filing management, and the third type of medical equipment is licensed for management. The second is to adhere to the principle of corporate responsibility. In order to highlight the responsibility of the business operation, medical device operating enterprises are required to establish an operation and management system covering the whole process of quality management in accordance with the requirements of medical device management quality management regulations, and ensure that operating conditions and business operations continue to meet the requirements. The third is to adhere to strict supervision principles. Through the comprehensive use of random inspection, quality announcement, flight inspection, responsibility interview, "blacklist" and other systems, enrich regulatory measures, improve regulatory means, and promote the implementation of regulatory responsibilities. The fourth is to adhere to the principle of tracking traceability. It is stipulated that enterprises should establish and implement a system for inspection and record of incoming goods. Business enterprises engaged in the second and third types of medical device wholesale business and the third type of medical device retail business shall establish a sales record system. Encourage other medical device operators to establish a sales record system. For enterprises engaged in the wholesale business of medical devices, their purchase, storage, sales and other records shall meet the requirements for traceability. What are the requirements for business management in terms of business management? The first is to strengthen the quality responsibility of enterprises. Enterprises are required to establish an operation and management system covering the whole process of quality management in accordance with the requirements of medical device management quality management regulations to ensure that operating conditions and business operations continue to meet the requirements. At the same time, a self-examination and reporting system was proposed for the third category of medical device operators. The second is to pay more attention to the quality management of the entire process. Strictly control the qualification review of procurement and sales links to ensure the legal circulation of medical devices; highlight the record requirements for incoming inspection and sales, and ensure the traceability of products; emphasize the storage and transportation requirements for low-temperature and refrigerated medical devices, and ensure products Transportation quality; requirements for the after-sales service of the operating company to ensure the safe use of the product. What conditions should a business enterprise that provides storage and distribution services for other medical device manufacturing enterprises? Medical device operating enterprises that provide storage and distribution services for Class II and Class III medical devices for other medical device manufacturing enterprises shall obtain medical device business licenses or filing vouchers. At the same time, it should sign a written agreement with the entrusting party to clarify the rights and obligations of both parties, and have equipment and facilities that are compatible with the conditions and scale of product storage and distribution. It has real-time electronic data exchange with the entrusting party and computer information traceable throughout the whole process of product operation. Management platform and technical means. The medical device operating enterprise shall evaluate and evaluate the storage and distribution service quality assurance capability provided by the medical device operating enterprise providing storage and distribution services, clarify the quality responsibility in the transportation process, and ensure the quality and safety during the transportation process. Fruit And Vegetables Cutting Machine fruit and vegetables be cut into clivers, pcs, and cubes Industrial Vegetable Cutting Machine,Vegetable Cutting Machine,Commercial Vegetable Cutting Machine,Fruit Dicing Machine JIANGSU SKYPLAN GREENHOUSE TECHNOLOGY CO.,LTD , https://www.engreenhouse.com