According to the announcement released on March 24, 2022 on the official website of the State Drug Administration, the 2017 edition of the Medical Devices Classification Catalogue "14-10-08 Liquid and Paste Dressings", which are managed as Class I medical devices, are "non-sterile liquid dressings and paste dressings that act as a physical barrier by forming a protective layer on the surface of the wound. Liquid dressings and cream dressings for the care of small wounds, abrasions, cuts and other superficial wounds and surrounding skin" have been adjusted to Class II medical device management.
It is mentioned that before January 1, 2022 has been in accordance with the 2017 version of the "Classification of Medical Devices Catalog" for the first class medical device products for the record, April 1, 2023 before the product record continues to be valid; since April 1, 2023, the products are not according to the law to obtain a medical device registration certificate shall not be produced, imported and sold.
The description of this category of products in the Medical Device Classification Catalogue: usually solutions or ointments (excluding gels), which are non-sterile products. The ingredients contained do not have pharmacological effects and cannot be absorbed by the body. It acts as a physical barrier by forming a protective layer on the surface of the wound. It is used for the care of small wounds, abrasions, cuts and other superficial wounds and the surrounding skin. Includes non-sterile provided liquid dressings, spray dressings, wound care ointments, liquid wound dressings, etc.
Since April 1, 2023, the production and sale of liquid dressings, cream dressing products that have not obtained a medical device registration certificate according to law, will be based on the "Supervision and Administration of Medical Devices Regulations" Article 81, the department responsible for drug supervision and management confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation; illegal production and operation of Medical devices worth less than 10,000 yuan, and impose a fine of more than 50,000 yuan 150,000 yuan; the value of more than 10,000 yuan, and impose a fine of more than 15 times the value of the amount of more than 30 times; the circumstances are serious, ordered to suspend production and business, 10 years not to accept the relevant responsible persons and units proposed medical device license applications, the legal representative of the offending unit, the main person in charge, directly responsible for the competent personnel and Other responsible persons, confiscate the income earned from the unit during the illegal acts, and impose a fine of more than 30% of the income earned more than three times the lifetime ban on its medical device production and operation activities.
