Landscape greening: According to relevant laws and regulations such as the Classification Catalogue of Medical Devices and the Classification Rules for Medical Devices, based on the development of medical dressing products and the current regulatory situation, the classification definition of medical dressing products was discussed and analyzed, and technical suggestions were proposed for medical device supervision and technical evaluation.

Landscape greening: The key to defining the classification of medical accessories and medical devices.

Landscape greening: Medical accessories are a common medical device widely used in the medical field, but their products are complex and regulatory difficulties are relatively high. In recent years, with the gradual enrichment of medical resources, the strength of medical security has gradually increased, the construction of basic medical facilities has accelerated, and the living standards and health awareness of residents have continuously improved. The medical dressing market has also ushered in a period of rapid development. According to BMIResearch, from 2014 to 2019, the market size of medical dressings in China increased from 3.989 billion yuan to 7.312 billion yuan, with a compound growth rate of 13.17%. It is expected to reach 8.225 billion yuan by 2020.

Landscape greening: In addition, with the development trend of new products and new technologies, various medical excipients are being sold in the market, which puts pressure and analysis on the supervision of medical devices. The country follows the standards of risk management, whole process control, disciplinary supervision, and social governance for medical device management methods, and implements classified management based on the risk level of goods.

Landscape greening: Different types of management methods have different regulations on the registration (filing), production and operation of goods. It is unclear how to distinguish the management methods of medical dressings. The category of management methods is the source of supervision and management, and it is also the key to supervision and management methods. On August 31, 2017, the National Medical Products Administration announced the "Classification Catalogue of Medical Devices" (hereinafter referred to as the new classification catalogue), which established three categories of management methods for medical excipient products. However, there are still controversies or a lack of scientific research methods in the specific classification and judgment. For example, in Zhejiang Province, about 10% of the 2600 medical device classification and judgment reports from 2015 to present are medical excipient products, It is not enough to immediately determine the category based on the published Classification Catalogue, and there is still considerable controversy.

Landscape greening: This article starts from the key factors that affect the risk of such products, such as whether they have pharmacological effects, whether the ingredients are absorbed by the human body, whether they provide sterility, whether they are used for chronic wound care, etc. [2], starting from whether they have pharmacological functions, whether the ingredients contained in them are absorbed by the human body, whether they provide aseptic functions, whether they are used for chronic wound care, etc. However, how to scientifically evaluate and distinguish these factors is the key to classification and definition work. The following technical discussions will be conducted from the aspects of product composition, mechanism of action, expected use, duration of action, and supply mode. Combined with the current situation of medical device supervision, evaluation methods for such products will be summarized, providing reference for daily filing, registration, or supervision.