In practice, single-use medical devices have problems of too many varieties and wide range, especially high-value medical consumable products, which greatly increase medical expenses and increase the burden on patients. In this regard, the provisions of the "Regulations" are clearly stipulated that the development of medical devices should follow the principles of safety, efficiency and economy; the implementation of catalogue management requires that the catalogue of disposable medical devices be formulated and adjusted by the General Administration of Food and Drug Administration in conjunction with the Health and Family Planning Commission. And announced; repeated use can ensure safe and effective medical equipment, not included in the single-use medical equipment catalog; for the design, production process, disinfection and sterilization technology, etc., after repeated use can ensure safe and effective medical equipment, should Adjust the list of disposable medical devices. The above provisions are conducive to reasonable control of the range of disposable medical devices, and to achieve maximum resource conservation and to alleviate the problem of “expensive medical treatment†while ensuring the safety and effectiveness of medical devices.
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China's medical device supervision needs to be classified and managed, and the strictness is different.
The medical instrument supervision policy is constantly revised and adjusted while the national conditions are constantly changing. The newly revised Regulations on Medical Device Supervision and Administration will be implemented on June 1, 2014. There are many types of medical devices, ranging from small tongue depressors to large-scale nuclear magnetic resonance instruments, and the risks of products vary greatly. There are implantable devices that directly affect life safety, as well as body-to-body. Auxiliary devices that have no direct impact on health. These characteristics of medical devices have determined that they must be strictly managed, and they cannot be “one size fits allâ€. They must be classified and managed.
The heads of the Legislative Affairs Office of the State Council and the General Administration of Food and Drug Administration have interpreted the contents of the Regulations on the Supervision and Administration of Medical Devices on regulating regulatory actions, ensuring the safety of medical devices, and promoting industrial development.
The person in charge said that classification management is an important system for achieving scientific supervision of medical devices. This revision has improved the classification management system. First, the medical equipment is divided into one, two and three categories according to the risk from low to high; the catalogue of products should be adjusted according to the production, operation and use of medical equipment, and the analysis and evaluation of product risk changes; To classify catalogues, it is necessary to fully listen to the opinions of production and operation enterprises, users, and industry organizations, and refer to the international medical device classification practice. The second is to implement product registration management for the first type of medical devices. The second category of medical devices is administered by the State Food and Drug Administration and the third category of medical devices by the State Food and Drug Administration. Management, the filing management of the second type of medical equipment, and the licensing management of the third type of medical equipment.
The "Regulations" have increased the responsibility of production and operation enterprises and users. First, increase the control responsibility of production and operation enterprises in terms of product quality. Enterprises are required to establish and improve the quality management system including product design and development, raw material procurement, production process control, etc. for the medical devices produced, keep the system running effectively and submit self-inspection reports on a regular basis. The second is to establish a system of incoming inspection and sales records for operations and use. The operating enterprise and the use unit are required to check the supplier qualification and product qualification certificate and record it; the second type of medical device wholesale enterprise and the third type medical device operating enterprise shall also establish a sales record. The third is to increase the safety management obligations of medical devices used by the units. Require the use of units to strengthen technical training for staff, ensure that medical equipment is used in accordance with product specifications, technical operation specifications, etc.; set up storage places that are compatible with the variety and quantity of medical equipment in use, and carry out maintenance work for large-scale medical equipment according to regulations. Wait.