(1) Products that play a major role in drugs and medical devices play an auxiliary role (such as syringes pre-loaded with drugs, etc.). ), according to drug management.
(2) For products with medical devices as the mainstay and drugs as the supplement (such as drug-containing stents, catheters with antibacterial coatings, drug-containing condoms, drug-containing contraceptive rings, etc.). ), according to the management of medical devices.
(3) Band-AIDS containing antibacterial and anti-inflammatory drugs are managed according to drugs.
(4) External products of traditional Chinese medicine are used as external preparations of traditional Chinese medicine, and are managed according to drugs. The advertisement of medical devices shall be examined and approved by the pharmaceutical supervisory and administrative department of the people's government at or above the provincial level; Without approval, it shall not be published, broadcast, distributed or posted. The contents of advertisements for medical devices shall be based on the instructions approved by the drug supervision and administration department of the State Council or the drug supervision and 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. Instructions for medical devices refer to technical documents produced by manufacturing enterprises and provided to users with products, which can cover the basic information of product safety and effectiveness and guide correct installation, debugging, operation, use, maintenance and maintenance. Medical device labels refer to text descriptions, figures and symbols affixed to medical devices or packages to identify product features. Medical device packaging label is a text description, graphics and symbols that reflect the main technical characteristics of medical devices on the packaging. Adverse medical device events refer to any harmful events that occur or may occur under the normal use of approved and qualified medical devices, which have nothing to do with the expected use effect of medical devices. There are four kinds of medical device adverse events that are serious injuries: life-threatening diseases or injuries; Permanent damage to bodily functions; Permanent damage to the body structure; Drug or surgical intervention is needed to avoid the above-mentioned permanent surgical injury and permanent destruction. The state implements classified management of medical devices: the first category refers to routine management, that is, devices that do not contact the human body or only contact the skin and mucosa, such as sphygmomanometer and thermometer. 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 medical devices implanted in the human body to support and maintain life, which are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled, such as various infusion sets, syringes, pacemakers, ventilators and so on. As can be seen from the above, firstly,
Class II and III medical devices should not be purchased for home use, because such medical devices are potentially dangerous after all, and their use requirements are strict, so they need to be highly cautious. In addition, there are still some new medical devices that need to be tried out, or products that are in the development stage or medical devices used in laboratories will be temporarily allowed to be used in designated hospitals without a license. This kind of medical device is obviously not suitable for ordinary consumers to buy and use blindly. Ma Meng (Beijing) Enterprise Management Co., Ltd. specializes in handling medical device business licenses and operates legally in strict accordance with regulations. Mengkaier provides the address of the park legally filed in Beijing, and cooperates to guarantee free maintenance and annual inspection for 5 years. At the same time, if you act as an agent in Dream Horse, Dream Horse will keep accounts and file tax returns on time and in compliance, and give professional financial advice to make the internal and external accounts of the enterprise legal and compliant, and help the enterprise to operate for a long time.
Legal basis: Article 4 of the Rules for the Classification of Medical Devices According to the degree of risk, medical devices are divided into Class I, Class II and Class III. The risk degree of medical devices should be comprehensively judged according to the expected use of medical devices, through structural characteristics, use forms, use status, contact with human body and other factors.