The state of medical devices to implement classification and management, the third category refers to

The State Council on January 4, 2000 promulgated the "supervision and management of medical devices regulations" on medical devices have a definition of medical devices, that is, medical devices refers to the use of the human body alone or in combination with the instruments, equipment, appliances, materials, or other items, including the required software; its use on the human body surface and the body's role is not to use the means of pharmacology, immunology or metabolism of the access to the body, but there may be these means involved and play a certain supporting role; its use is intended to achieve the following intended purposes: the prevention, diagnosis, treatment, monitoring, alleviation of disease; the diagnosis, treatment, monitoring, alleviation, compensation for injury or disability; the study of anatomical or physiological processes, substitution, regulation; pregnancy control. Medical devices are divided into three categories: Category 1: medical devices that are sufficiently safe and effective through routine management. Such as most of the surgical instruments, stethoscopes, medical X-ray film, medical X-ray protection, automatic electrophoresis, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, band-aids, surgical gowns, surgical caps, masks, urine collection bags and so on. Class II: medical devices whose safety and effectiveness should be controlled. Such as thermometers, sphygmomanometers, cardiac diagnostic instruments, optical endoscopes, dental comprehensive treatment instrument, medical degreasing cotton wool. Class III: implanted in the body; used to support life support; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices medical education | net editorial organization. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, invasive endoscopy, ultrasound scalpel, laser surgical equipment, blood transfusion, single-use infusion set, single-use sterile syringes, CT equipment.

(1) For products in which drugs play a major role and medical devices play an auxiliary role in drugs (such as syringes pre-filled with drugs, etc.), they are managed as drugs.

(2) Products in which medical devices play a primary role and drugs play a secondary role (such as drug-containing stents, catheters with antimicrobial coatings, drug-containing condoms, drug-containing birth control rings, etc.) are managed as medical devices.

(3) Band-Aids containing antibacterial and anti-inflammatory drugs are managed as drugs.

(4) Traditional Chinese medicine external application patch products as traditional Chinese medicine external application patch, according to the management of drugs. Medical device advertisements should be examined and approved by the drug supervision and management department of the people's government at or above the provincial level; without approval, shall not be published, broadcast, distributed and posted. The content of medical device advertisements shall be based on the instructions for use approved by the drug administration department of the State Council or the drug administration department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. Medical device product standards are divided into national standards, industry standards and registered product standards medical device manuals are produced by the manufacturer and provided with the product to the user, can cover the product safety and effective basic information and used to guide the correct installation, commissioning, operation, use, maintenance, maintenance of technical documents. Medical device labeling refers to the medical device or packaging attached to the text description and graphics, symbols used to identify the characteristics of the product. Medical device packaging labeling refers to the packaging labeled to reflect the main technical characteristics of the medical device text description and graphics, symbols. Adverse event of medical device refers to any harmful event that occurs or may occur under normal use of approved and qualified medical devices, which has nothing to do with the expected effect of the use of medical devices. There are 4 kinds of medical device adverse events belong to serious injury: lead to life-threatening diseases or injuries; permanent damage to the function of the muscle; permanent damage to the structure of the muscle; the need for drug or surgical intervention to avoid the above permanent manipulation of the injury and permanent damage and so on. The state of medical devices to implement classification management: the first category refers to the routine management, that is, not in contact with the human body or only contact with the skin and mucous membranes of the device, such as blood pressure monitors, thermometers and so on. The second category refers to medical devices whose safety and effectiveness should be controlled, such as x-ray machines. The third category refers to the implantation of the body, used to support, maintain life, and potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices, such as a variety of infusion sets, syringes, pacemakers, ventilators, etc.. From the above, it can be seen that the first

The second and third categories of medical devices should not be purchased on their own for home use, because after all, there is a greater potential danger of this type of medical equipment, the use of strict requirements, the need for a high degree of caution. In addition, there are still some need to try the new medical device products, or in the development stage of the product or in the laboratory to use the medical device, will be temporarily allowed to designated hospitals "unlicensed" state of the use of this type of medical equipment is obviously not suitable for the general consumer blindly buy and use. Mengma (Beijing) Enterprise Management Co., Ltd. specializes in handling medical device business license, in strict accordance with the provisions of the legal operation. Dream Horse can provide Beijing legal filing park address, cooperation to ensure 5 years, free maintenance and annual inspection every year, at the same time if you are in Dream Horse agent bookkeeping, Dream Horse on time and compliant bookkeeping and tax reporting, and give professional financial advice, so that the enterprise's internal and external accounts are legal and compliant, to help the enterprise to operate in the long term.

Legal basis: "Medical Device Classification Rules" Article IV medical devices in accordance with the degree of risk from low to high, the management category is divided into the first, second and third categories. The degree of risk of medical devices, should be based on the intended purpose of medical devices, through the structural features, the use of forms, the use of state, whether contact with the human body and other factors to determine the comprehensive.