There is no "mechanical mask"


China Economic Weekly—Economics News On January 2, 2020, the official website of the State Food and Drug Administration issued a warning about the mask consumption trap. With the upgrading of public consumption, medical beauty is getting closer to our lives, and various laser treatments and skin care items are sought after by consumers. After medical and cosmetic treatment, consumers are often recommended to use various so-called "mechanical masks" and "medical beauty masks" (usually the registered product registration number is "X-machine injection standard" or "X-machine preparation", etc.) or "Medical makeup mask" named "Medical Skin Care". These products are claimed to be higher than ordinary masks, powerful, safer and more suitable for consumers. Are the so-called "mechanical masks", "medical skin care products", etc. better consumer choices for skin care? The State Administration of Drug Administration states:

1. There is no "mechanical mask"

The so-called "mechanical mask" is actually a medical dressing and belongs to the category of medical equipment. Medical dressings can be in direct or indirect contact with the wound, and have the medical effects of absorbing wound exudate, supporting organs, preventing adhesions, or providing a suitable environment for wound healing. Medical dressings managed according to medical devices can be divided into three categories: surgical dressings (divided into absorbable and non-absorbable dressings), contact wound dressings (divided into acute wound dressings and chronic wound dressings), and bandaged fixed dressings.

According to the Regulations on the Supervision and Management of Medical Devices, medical dressing products are classified according to the degree of risk from low to high, and are managed according to the first, second, and third types of medical devices. Where medical dressings are claimed to be sterile, their management category is at least the second type of medical devices; if they come into contact with wounds deep in the dermis or below, or are used for chronic wounds, or can be absorbed in whole or in part by the human body, their management The category is the third category of medical devices. Before the domestically produced second-class medical device products need to be registered with the provincial drug regulatory authority; before the market for third-class medical devices and imported second-class medical devices, they must be registered with the State Drug Administration.

The naming of medical dressings managed in accordance with medical devices shall meet the requirements of the "General Rules for the Naming of Medical Devices", shall not contain claims such as "cosmetics", "health care", etc., and shall not contain exaggerated scope of application or other misleading and deceptive content. Therefore, the concept of "mechanical mask" does not exist, and medical device products cannot use "mask" as its name.




Updated date: 2020/01/11

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