The classification of mechanical brand products is based on the medical device classification management of China National Medical Device Administration. According to the Regulations on the Supervision and Administration of Medical Devices, products with mechanical brand names are divided into Class I, Class II and Class III, and the differences are as follows:
1, a kind of machinery: refers to medical devices that have no direct or auxiliary effects on human body. This kind of products are usually the simplest and most common instruments, such as thermometers and masks. And they are relatively simple to use and have low risk.
2. Class II machinery: refers to medical devices that have certain effects on human body and require high safety. The design, production and use of such products need to be carried out in accordance with relevant technical standards and regulations, such as electrocardiograph and sphygmomanometer.
3. Three types of machinery: refers to medical devices with high risk to human body and requiring stricter supervision. These products are usually used to diagnose and treat serious diseases, such as pacemakers and artificial joints.
4, a kind of machinery does not need to go through clinical trials, but it needs to be registered in the State Administration of Medical Products. Class II equipment needs clinical verification and safety evaluation, and has been registered and approved by the State Administration of Medical Products.
The design, production and use of the three types of machinery need to be highly supervised, and clinical experiments and safety evaluation must be carried out. They must be registered and approved by the State Administration of Medical Products before they can be sold and used in the market.
The following is a description of the machine name.
The name of machinery refers to the unique identification symbol obtained after the medical device is registered in China National Medical Products Administration. It is a kind of logo similar to the approval number of drug marketing license, which is used to distinguish legally registered medical device products.
The machine name usually consists of a series of numbers and letters, which can be found on the packaging, label or instruction manual of the product. Each machine name corresponds to a specific medical device product, which is used to confirm that the product has passed the registration examination and approval in the State Administration of Medical Device Products, meets the requirements of relevant technical standards and regulations, and can be legally sold and used in the market.
When purchasing medical devices, consumers can check the machine name of the product, confirm whether the product has been legally registered and know the corresponding machine category. This helps to ensure that the quality and safety of purchased medical devices meet the national standards and meet the requirements of laws and regulations.