I. What is a medical device medical device refers to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; its utility is mainly through physical and other means, not through pharmacological, immunological or metabolic means, or although these modalities are involved but only play an auxiliary role; its The purposes are (1) diagnosis, prevention, monitoring, treatment, or mitigation of disease; (2) diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; (3) examination, substitution, modulation, or support of physiological structures or processes; (4) support or maintenance of life; (5) control of pregnancy; and (6) provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
II. How medical device products are categorizedThe state implements categorized management of medical devices according to the degree of risk. The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), gua sha board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on. Surgical instruments belong to the first class of medical devices Class II is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalographs, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on. We are familiar with the mercury sphygmomanometer belongs to the second class of medical devices Class III is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters and so on. Several implantable medical devices can be seen in the country for medical devices have a strict classification, and class III medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, is implanted in the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices.
Three. What are the medical device standards medical device standards are divided into national standards and industry standards. (1)National standards or industry standards are standards that need to be unified technical requirements on a national scale. (2) The technical requirements need to be unified on a national scale, national standards should be formulated. National standards shall be formulated by the administrative department for standardization under the State Council. There is no national standard and the need to unify the technical requirements within an industry nationwide, industry standards can be formulated. Industry standards formulated by the relevant administrative departments of the State Council, and reported to the State Council administrative department in charge of standardization for the record, national standards, industry standards are divided into mandatory standards and recommended standards. The State Food and Drug Administration (CFDA) promulgated the "Medical Device Standards Management Measures" IV. Medical devices need to be approved before the listing of inspection and testing of Class II and Class III medical devices need to be declared for registration to the State Food and Drug Administration recognized inspection and testing organizations for registration and testing. V.. The scope of application of medical device products refers to what the scope of application of medical device products is generally based on clinical trials approved by the Food and Drug Administration, shall not be arbitrarily exaggerated or changed.
Legal Objective ：
According to China's "Regulations for the Supervision and Administration of Medical Devices", Article 9 provides that: the first class of medical device products for the record and apply for registration of the second and third class of medical device products, the following information should be submitted: (a) product risk analysis information; (b) product technical requirements; (c) product testing report; ( (D) clinical evaluation information; (E) product specifications and labeling samples; (F) and product development, production-related quality management system documents; (G) to prove that the product safety, effective and other information required. Applicants for registration of medical devices, the filer shall be responsible for the authenticity of the information submitted.