Food and Drug Administration mechanical production record number is a medical device allows the production of the record number, not the record number of drugs. Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly for the human body, including the need for computer software. Medical devices include medical equipment and medical consumables. Efficacy is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or although these means are involved but only in an ancillary manner. Medical device industry involves many industries such as medicine, machinery, electronics, plastics, etc. It is a multidisciplinary cross, knowledge-intensive, capital-intensive high-tech industry. And the basic characteristics of high-tech medical equipment is digital and computerized, is a multidisciplinary, cross-field crystallization of modern high technology.
Legal basis: "Supervision and Management of Medical Devices Regulations," Article VI
Medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards should be in line with the mandatory industry standards for medical devices.
Disposable medical device catalog by the State Council food and drug supervision and management department in conjunction with the State Council competent department of health planning to develop, adjust and publish. Repeated use can ensure the safety and effectiveness of medical devices, not included in the single-use medical device catalog. For the design, production process, sterilization technology and other improvements in repeated use can ensure the safety and effectiveness of medical devices, should be adjusted out of the directory of single-use medical devices.