Garden and greenery manufacturers: According to the Notice of the General Office of the State Food and Drug Administration on the Implementation of Class I Medical Device Filing Matters (Food and Drug Administration Machinery Management Bureau [2014] No. 174), the product category of medical dressings provided in a sterile manner shall not be lower than that of Class II medical device management. If medical dressings are provided in a non sterile manner, and their components are not absorbed by the human body, and they do not have pharmacological functions, passive products can be managed as a type of medical device.

Landscape and greening manufacturers: According to the management of Class III medical devices, all medical dressings used for chronic trauma (long-term non healing wounds caused by various reasons), body trauma care, lubrication, anti adhesion, tissue filling support, etc; If it is only used for small abrasions, shallow second degree burns, and scalds on the surface of the skin (dermis and below), and the ingredients are not absorbed by the human body and do not have pharmacological effects, it can be managed according to the category of medical devices; If only complete skin moisturizing or acne removal function is used, it will not be managed as a medical device; If only a protective layer is formed on the surface of the wound as a physical barrier for medical dressings (such as film-forming, non irritating to the body surface), it can be used as a type of management for similar medical devices.

Landscape greening manufacturer: usage time limit

Landscape greening manufacturers: There are three types of medical devices based on their continuous use time with the human body (the actual use time of medical devices depends on the expected purpose and time): if the continuous use time is less than 24 hours, it is temporary use; If the time exceeds 24 hours (including) and 30 days, it is considered short-term use; If the time exceeds 30 days (including), it is considered long-term use [5]. If it acts on the skin/cavity (oral cavity) and its continuous use with the human body is temporary or short-term, it can be used for the management of Class I medical devices. If other parts are temporary or short-term, it can be used as Class II medical devices; Long term use of medical excipients can be used for the management of Class III medical devices.

Gardening and greening manufacturers: Principles for the combination of medical accessories and medical equipment.

Gardening and greening manufacturers: Medical excipient products have specialized management categories for medicinal herb combinations, which is a difficult and key point in classification definition. With the continuous emergence of new technologies and products, new polymers or functional components are added to medical excipients, forming a large category of popular dressings. If it belongs to medical excipients containing medicinal ingredients or excipients, it is generally classified as drug combination products. According to the Notice on Adjusting the Attribute Definition of Drug Combination Products (No. 28 of 2019), it can be directly reported to the Medical Device Standard Management Center for acceptance of attribute definition. However, how to distinguish between drug dominated or drug dominated drug combinations is the key to the classification of such products.

Landscape and greening manufacturers: Generally speaking, if the ingredients of a product contain drugs and the pharmacological effects of drug combinations are expected to be used to exert their effects, such products may be defined as drug based drug combinations, which need to be registered according to the drug registration management method; If the ingredients of a product are only used as drug content, but the content of a drug combination product is extremely low and does not primarily function to exert pharmacological effects, then such products can be defined as drug based drug combination products,