In recent years, with the popularity of light medical beauty, the products of "beauty mask" and "machine name mask" have been touted as hot products. In fact, this kind of product is a kind of medical dressing, which is mainly used for skin repair after medical art such as water light, microneedle, ultrasonic knife and laser.

During this year's "double 11" Shopping Festival, sales of "medical beauty mask" and "machine name mask" are still hot. Tmall medical health data show that in the first hour of the pre-sale of tmall's "double 11" Shopping Festival in 2021, the turnover of such products increased by more than 200% year-on-year. However, in recent years, with the continuous increase of supervision and popular science, the medical dressing industry has ushered in standardized development while maintaining the growth trend.

Enterprises have repeatedly "hit the edge"

In recent years, the sales volume of patch medical skin repair dressing in China has shown a rapid growth trend.

——According to the statistics of punctuation medicine, the consumption of medical patches and medical skin repair dressings in China has increased from 161 million in 2017 to 417 million in 2020. China Business Research Institute predicts that this number will increase to 505 million in 2021.

Judging from the turnover of Taobao Tmall platform, from July 2019 to June 2020, the patch mask with "repair" effect amounted to 1 billion 653 million yuan, accounting for 12.23% of the total patch film.

——Ecdat away data shows that during the "June 18" period this year, the sales of only one brand of Fumei on tmall platform exceeded 100 million yuan, with a year-on-year increase of more than 310%.

Why is "medical beauty mask" and "machine name mask" so popular? In this regard, Miao Baoying, executive vice president of Nantong Pharmaceutical Association, Jiangsu Province, said that the key to the rapid growth of sales of such products is the word "medicine". Consumers generally believe that "medical beauty mask" and "machine name mask" can both "beauty" and "medical treatment", and its "medical" related skin care effect will be better. The production enterprise carries on the propaganda and promotion in the name of the "brand name mask". It can not only retain the impression that the medical devices give consumers the "strict production environment" and "good product quality", but also avoid the relevant regulatory requirements.

In fact, behind the prosperity of this kind of product market is the false publicity of "playing a marginal ball" and the loopholes of enterprises in the requirements of filing management.

China implements filing management for class I medical devices. Enterprises only need to file in the Municipal Drug regulatory department for sales, and the application and approval procedures are relatively loose; Unlike cosmetics, medical device products do not need to indicate all components in the ingredient list, nor do they need to be marked according to the order of component content from high to low. This makes some enterprises opportunistic, put medical dressings and other products on the record according to the first class of medical devices, and promote them as cosmetics.

Regulatory regulation

In view of the chaos of "medical beauty mask", as early as January 2020, the State Drug Administration issued the "Cosmetic Science Popularization: to guard against the mask consumption trap". It clearly pointed out that there was no concept of "mechanical mask", and the medical device products could not use the "Mask" as its name. The relevant departments of the state acted promptly to say "no" to the "brand name mask". Subsequently, all parts of the country responded positively and concentrated on cleaning up the "brand name mask" products.

In August 2020, Shanghai took the lead in stopping the "brand name mask", and gradually cancelled the production qualification of the first class medical device manufacturers of a number of "brand name mask", involving a total of 255 enterprises. In November of the same year, the Shanghai food and Drug Administration issued a notice on the guidelines for the filing of class I medical devices in Shanghai, focusing on putting forward requirements for the filing and production filing of class I medical devices, and strengthening the source control of the filing. The work guide pointed out that the "mechanical name" products can not appear beyond the product itself and the intended use of the description, such as repair (repair) type, essence, swelling, pain relief, relieve allergy, inhibit pigmentation, acne elimination, anti-inflammatory and so on.

At the beginning of this year, market supervision bureaus all over the country carried out special inspection on the filing and cleaning norms of class I medical devices focusing on "medical cold compress".

On January 19, Zhuhai Municipal Market Supervision Bureau issued the notice on printing and distributing the work plan for the filing and cleaning of class I medical devices, which made it clear that the products to be cleaned up include medical cold compress stickers. If it is found that the production conditions of class I medical device manufacturers are inconsistent with the filing information, provide false filing materials If the production conditions of the enterprise do not meet the requirements of the medical device quality management system and fail to rectify and stop production as required, it will be dealt with according to law.

The guidelines for the filing and cleaning up of class I medical devices issued by Huadu District of Guangzhou puts forward that if the name of the registered product is not standardized, the efficacy is asserted, it is easy to be confused with the drug name, and the intended use of the registered product is not standardized, the product filing needs to be changed or cancelled, and the relevant statements should be standardized. In addition, Gansu Province, Guangxi Zhuang Autonomous Region, Heilongjiang Province, Fujian Province and other drug regulatory departments have carried out clean-up actions for the registration and filing of medical devices, focusing on cracking down on problems such as "high category and low planning", "high category and low preparation" and "illegal declaration", so as to consolidate the main responsibility of enterprises.

While standardizing the product registration, the provincial drug administration departments have also stepped up scientific propaganda to guide consumers to scientifically understand the facial mask. Sichuan, Gansu and other places of the drug administration departments launched the relevant science popularization through the official WeChat official account to remind consumers not to blindly follow suit, to protect their skin scientifically and cautiously, and to buy mask products cautiously.

The drug control department "medical beauty mask" and "machine name mask" have achieved remarkable results in centralized cleaning and cleaning operations. At present, in Tmall / Taobao and other electronic business platform search, "mechanical mask", the page shows that "did not find the relevant treasure." In some product descriptions of best-selling medical dressings, the "non mask" and other suggestive words are also noted, involving false propaganda such as whitening, acne elimination and so on.

Growth of medical dressing industry slows down

Under the influence of factors such as the rapid growth of the medical and American market, China's medical skin repair dressing industry has entered a stage of rapid development. The high profit margin and broad market development space have attracted many enterprises.

At the end of 2020, Guangzhou chuang'er Biotechnology Co., Ltd. (hereinafter referred to as chuang'er Biotechnology) which has been deeply engaged in the medical skin repair dressing industry for a long time was adopted at the municipal Party committee meeting on the science and innovation board. According to the prospectus of the company, from 2017 to 2019, the overall gross profit margin of chuang'er biology was 80.57%, 83.65% and 83.51% respectively, which has been maintained at more than 80%.

Recently, the I PO status of Harbin fuerjia Technology Co., Ltd. (hereinafter referred to as fuerjia) was updated to "inquired", which is one step closer to listing. During the "double 11" Shopping Festival of tmall in 2019, "sales ranking of health equipment industry" shows that fuerjia flagship store tops the list, among which the best-selling model is "medical sodium hyaluronate repair patch", with nearly 300000 transactions per month. However, from its prospectus (declaration draft), fuerjia's recent revenue is not optimistic. In addition to being criticized for the proportion of R & D investment of 0.09%, the revenue growth of its "fist products" has also slowed down significantly, and even declined.

In fact, under the rectification of the industry and the return of consumers to rationality, according to its prospectus (application draft), the net profit of shareholders belonging to the parent company of fuerjia not only declined in 2020, but also the revenue of medical sodium hyaluronate repair paste (white film) among the three major medical device products decreased from 643 million yuan in 2019 to less than 600 million yuan, The medical sodium hyaluronate repair patch (black film) also had almost zero growth, and its savage growth pressed the deceleration key.

At the same time, due to the large number of patch mask brands in the market, the medical dressing market is gradually concentrating on the head brand. According to the data of punctuation medicine, "chuangfukang" under chuang'er biology and similar brands "fuerjia", "Rongsheng", "Kefu" and "kefumei" jointly occupy nearly 70% of the market share of patch medical skin repair dressings in China. Among them, fuerjia, kefumei and other brands have made full use of the e-commerce model to cultivate a large number of consumers, and have a high market share in the network channels. With the accelerated iteration of industrial technology update, it can be predicted that the market competition of patch medical skin repair dressing will further intensify.

From the regulatory signals released by relevant departments, it is not difficult to see that in the future, we will strengthen the punishment of violations of "machinery brand" products and further standardize the market order of medical devices. Only by taking the road of standardized development can medical dressing enterprises stand firm in the increasingly fierce market competition.

[source] China Medical Journal

The translational medicine branch of the National Health Industry Enterprise Management Association (hereinafter referred to as the branch) is a branch of the National Health Industry Enterprise Management Association (hereinafter referred to as the general association). The National Health Industry Enterprise Management Association is a national first-class social organization with industry management functions under the leadership of the Ministry of civil affairs, the working committees of central and state organs and the guidance of the National Health Commission. It is a national and industrial social organization voluntarily formed by medical, service, scientific research, management units, experts, entrepreneurs and other personnel engaged in mass health related. It is a non-profit social organization. The purpose of the association is to "protect health, develop industry, innovate in good faith and serve the society", promote the development of health industry enterprises and serve the national economic construction and people's health. Cctmis (branch of translational medicine industry of National Health Industry Enterprise Management Association) is committed to building a platform of "industry university research medicine and collaborative innovation". At present, the association has 40 collaborative groups classified according to diseases and more than 4000 members, of which more than half are clinical expert doctors!

Post time: Jan-25-2022