In daily life and work, people for the first, second and third class medical devices contain what is also focusing on the attention of many people may just have a certain understanding of it, but the specifics of what it is, may not be too clear, the next by the small make-up for you to bring about on the first, second and third class medical devices contain what the answer to the hope that it is helpful to you! I hope it will be helpful to you. I. What is a medical device Medical devices are 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 means, not through pharmacological, immunological or metabolic means, or although there are these ways to participate in the auxiliary role only; the purpose is to. purposes are: (1) diagnosis, prevention, monitoring, treatment, or mitigation of disease; (2) diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; (3) testing, replacement, modulation, or support of physiological structures or processes; (4) support or maintenance of life; (5) control of pregnancy; and (6) informing medical or diagnostic purposes through the examination of specimens from the human body. II. How medical device products are categorized The state implements classification and management of medical devices according to the degree of risk. The first category is low-risk, routine management can ensure the 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 The second class is a medical device with moderate risk, which requires strict control and management to ensure its safety and effectiveness. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, 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 It can be seen that the country has a strict classification of medical devices, and Class III medical devices are the highest level of medical devices, and must be strictly controlled, refers to the implantation of the human body, for the purpose of supporting and sustaining life, with potential danger to the human body, and must be strictly controlled for its safety and effectiveness. III. 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 standardized across the country for technical requirements. (2) For technical requirements that need to be unified nationwide, 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 Standard 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.. What is the scope of application of medical device products The scope of application of medical device products is generally approved by the Food and Drug Administration on the basis of clinical trials, and shall not be arbitrarily exaggerated or changed. Therefore, consumers should carefully check the scope of application, contraindications, precautions and other content of the product before purchase to analyze whether the product is applicable. The above content is based on China's current relevant laws and regulations on the first, second and third class medical devices include what made a detailed introduction. If you have any questions about the above, you can consult the relevant websites or departments! If you need more legal answers, you can consult a lawyer online!
Legal objective:According to China's "supervision and management of medical devices regulations" Article IX provides that: the first class of medical device products for the record and apply for registration of the second class, the third class of medical device products, should be submitted to the following information: (a) the product risk analysis information; (b) the product technical requirements; (c) the product test report; (d) clinical evaluation information; (e) product instructions (E) product specifications and labeling samples; (F) product development, production and quality management system documents; (G) to prove that the product is safe, effective and other information required. Applicants for registration of medical devices, the record shall be responsible for the authenticity of the information submitted.