At present, consumers' pursuit of beauty continues to upgrade, and beauty and health-related beauty instruments have mushroomed. Because of its many categories, diverse functions, convenient use, rich sense of technology and other characteristics, coupled with a large number of business advertising, star support, beauty instrument sales in recent years to maintain a rapid growth trend. The "2020-2026 China Beauty instrument industry market scale research and development trend Analysis Report" released by Zhiyan Consulting predicts that the demand for beauty instrument in China will increase from 1.31 million units to 6.552 million units in 2014-2019, with a compound growth rate of 37.79%, and the market size of China's home beauty instrument will exceed 20 billion yuan in 2026. In view of the development prospects of beauty instruments, traditional home appliance companies such as Pentium and Panasonic have launched different functions of home beauty instruments; Some cosmetics companies such as L 'Oreal, Procter & Gamble, Clinique, etc., have also begun to get involved in this field, developing home beauty instruments related to skin care. Beauty instrument track has also gradually run out of a number of professional brands, such as Ya Meng, early Pu, find light, time bay, Ke Shi Jia and so on. This article will discuss the five core issues of beauty instrument product compliance for operators' reference.

According to the relevant provisions of the Regulations on the Supervision and Administration of Cosmetics, cosmetics refer to daily chemical industrial products that are applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying. In terms of product attributes, cosmetics belong to the category of daily chemical and chemical products. In view of the direct contact of cosmetics with the human body surface and safety considerations, China implements a note or registration management system for cosmetic products, and implements licensing management for cosmetic production. Although the beauty instrument is highly similar to cosmetics in the functions of cleaning, moisturizing, whitening, anti-wrinkle, slimming, removing blackheads, acne and so on, the product properties do not belong to the category of daily chemical products, not cosmetics; In principle, the operator does not need to register or file the beauty instrument in accordance with the cosmetic regulatory requirements. However, some beauty devices are used in conjunction with cosmetics. According to the requirements of the Provisions on the Management of Cosmetic Registration and Filing Data, cosmetic operators shall carry out product safety assessment in accordance with the requirements of the technical guidelines related to cosmetic safety assessment when conducting cosmetic registration or filing, and form product safety assessment reports; For cosmetics that must be used with instruments or tools (except brush, air cushion, hair perm tools, etc.), the safety under the conditions under which the instruments or tools are used shall be assessed, and whether the instruments or tools have cosmetic functions during the use of the products and whether they participate in the reproduction process of cosmetics shall be provided. Information on whether to change the mechanism of action between the product and the skin.

According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, medical devices refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly used in the human body, including the required computer software; Its effect is obtained mainly by physical means, not by pharmacological, immunological, or metabolic means, or although these means are involved but only play an auxiliary role; Its purposes are: (1) diagnosis, prevention, care, treatment or remission of disease; (2) diagnosis, monitoring, treatment, mitigation or functional compensation of injury; (3) testing, substituting, regulating or supporting physiological structures or processes; (4) life support or maintenance; (5) pregnancy control; (6) To provide information for medical or diagnostic purposes by examining samples from human bodies. In view of the intended use of medical devices and safety considerations, China implements the filing or registration management of medical device products, and at the same time implements special management of medical device production and management. Compared with medical devices, beauty instruments are also directly or indirectly used for the human body, and its effectiveness is mainly obtained through physical and other ways, not through pharmacology, immunology or metabolism, but the beauty instrument is mainly used for cleaning, wrinkle removal, anti-aging, hair growth and other beauty purposes, the intended use of medical devices is mainly for disease treatment, relief, etc. They belong to different categories. At present, China implements catalogue management for medical devices. In business practice, if the product description and intended use of a specific beauty instrument exceeds the beauty category and involves the intended use of disease treatment, relief, etc., it will be identified as a medical device, especially a physical therapy device. For example, the treatment of acne, folliculitis and other infectious diseases on the surface of the blue light therapy instrument belongs to three types of medical devices; Low potential therapeutic devices for the auxiliary treatment of headaches, insomnia, chronic constipation and pain caused by soft tissue injury belong to the second class of medical devices; Used to improve the appearance of the skin treatment, vascular diseases, skin superficial pigmented diseases and reduce hair treatment of intense pulse light therapy instrument is a second class of medical devices. Beauty equipment operators should strictly define product attributes according to the product description and intended use of the instrument; If the product belongs to the medical device category, it is necessary to implement the medical device management system, such as product filing or registration.

According to the relevant provisions of GB5296.2-2008 "Instructions for the Use of Consumer Goods Part 2: Household and similar Electrical Appliances", small household appliances generally refer to electrical appliances used by non-professionals in families, apartments and similar occasions. Given that household beauty devices meet the two applicable conditions for use in homes, apartments and similar occasions and for use by non-professionals, it is generally considered that household beauty devices fall under the category of small household appliances. Because the beauty instrument belongs to the category of small household appliances, the product needs to meet the relevant technical standards of small household appliances, For example, GB 4706.1-2005 "Safety of household and similar electrical appliances: General requirements", GB 4706.15-2008 "Safety of household and similar electrical appliances: Special requirements for skin and hair care appliances", GB/T 36419-2018 "Beautiful skin containers for household and similar uses", etc.

Mandatory product certification means that in order to protect national security, protect human health or safety, protect animal and plant life or health, and protect the environment, the State stipulates that the relevant products must be certified, certified and marked with certification marks, before they leave the factory, sell, import or use in other business activities. According to the relevant provisions of the "certification and Accreditation Regulations", China implements catalog management for mandatory certification products, and unified product catalogs, unified technical specifications, mandatory requirements, standards and conformity assessment procedures, unified marks, and unified charging standards for products that must be certified. The Compulsory product Certification mark is a 3C pattern, in which CCC is the abbreviation of China Compulsory Certification, the English name of China Compulsory Certification. In 2020, in order to further deepen the reform of the mandatory product certification system, according to the adjustment of the mandatory product certification catalogue, on the basis of not changing the scope of implementation of mandatory product certification, some product categories in the Mandatory Product Certification Catalogue will be merged and optimized. The optimized mandatory product certification catalogue has a total of 103 products in 17 categories, of which category 709 is "skin and hair care appliances". What is "skin and hair care appliance"? The Mandatory Product Certification Catalogue Description and Definition Table (2020 Revision) further clarifies: "Skin and hair care appliances" products means "personal care appliances with electric heating elements for hair or skin care with a rated voltage not exceeding 250V", such as hair dryers, hand dryers, electric combs, hair curlers, hair clips, hair qualifiers, facial saunas, etc. However, it does not include "medical skin and hair care devices, electric shavers, beauty instruments, makeup remover, and drug devices with therapeutic functions". Compared with the original rules, the revised "Compulsory Product Certification Catalogue" in 2020 clearly excludes beauty instruments from the category of compulsory certification products, except for products such as "hair dryers, hand dryers, electric combs, hair curlers, hair clips, hair qualitators, and facial saunas." In view of the fact that laws and regulations have not yet clarified the definition and boundaries of "beauty instruments", operators need to judge whether mandatory product certification is required. In addition, some businesses based on the needs of marketing, will not be in the "mandatory product certification directory" beauty instruments sent for voluntary certification, obtain a "product certification certificate" to prove the safety of the product, but the "product certification certificate" and "national mandatory product certification certificate" are two different concepts.