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Can the home beauty device industry revive after a two-year extension of the new regulations?

Can the home beauty device industry revive after a two-year extension of the new regulations?

Can the home beauty device industry revive after a two-year extension of the new regulations?

2024-10-31 16:21 https://www.huxiu.com/article/3242362.html
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Home Beauty Device Industry | New Regulations Delayed

Can the home beauty device industry revive after a two-year extension of the new regulations?

Economic Observer

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This article is from the WeChat official account: Economic Observer (ID: eeo com cn). The author is Xie Chuchu. The title is from Visual China.


The home beauty device industry has gained another two-year window period.

In March 2022, the National Medical Products Administration adjusted the content of the "Classification Catalog of Medical Devices", clarifying that radiofrequency therapy devices and radiofrequency skin therapy devices were included in the three categories of medical device catalog management. At that time, all household beauty devices on the market were managed according to the standards for small household appliances, but the standards were not mandatory. Since then, many top brands have started preparing for the registration of Class III medical devices in order to continue selling RF products. According to the new policy, manufacturers are not allowed to sell beauty devices if they are unable to obtain a Class III medical device registration certificate. The new policy will be implemented on April 1, 2024.

As the time limit approaches, there has been a big sale in the beauty device market, with products originally priced at over 3000 yuan reduced to a few hundred yuan, and manufacturers have also taken down RF products. The rapidly growing home beauty device industry has entered the regulatory era from the era of savage growth.

But just as brands are rushing to regain their sales qualifications and adjust their business direction, they have regained the policy window period. On July 8th, the National Medical Products Administration issued a notice on further clarifying the requirements for radiofrequency therapy equipment products. Starting from April 1st, 2026, products such as radiofrequency therapy equipment and radiofrequency skin therapy equipment in the 09-07-02 radiofrequency therapy (non ablation) equipment attachment of the "Notice on Adjusting Part of the Classification Catalogue of Medical Devices" (No. 30 of 2022) that have not obtained a medical device registration certificate in accordance with the law shall not be produced, imported, or sold.

On July 10th, the relevant person in charge of Miguang brand told the Economic Observer that "we are still understanding the specific details of the policy with the relevant departments, and the specific response strategies are not coming out so quickly. Recently, the bosses and colleagues in the product development department are also discussing it." An unnamed head beauty device brand leader said that the new announcement is "very sudden" for all brands.

Chen Liang, a senior beauty device industry expert and former brand manager of TriPollar in China, told Economic Observer that the delay of the new regulations means that the market regulatory authorities have given RF beauty device brands an extra two years of breathing space to prepare for medical device registration. But he believes that obtaining certification may not be the top priority for brands at present. Against the backdrop of overall declining consumer power, the top priority for brands is to "survive the cold winter".

Delay

Regarding the sudden delay of the new regulations, the head of the aforementioned beauty device brand stated that the vast majority of brands, including themselves, are still in the stage of understanding the news and cannot provide precise information on whether to re-launch RF products. "Most companies' business layouts (reports) have been disrupted."

The relevant person in charge of Miguang brand said that according to the documents released by the National Medical Products Administration, reselling RF products should be allowed, but what are the specific requirements? What is the difference from the previous regulations? We are still learning about it. The company is still studying the follow-up arrangements for whether to re-launch RF products.

In its interpretation of the announcement on the extension of the new regulations, the National Medical Products Administration stated that at present, the registration applicants for handheld radiofrequency therapy devices and radiofrequency skin therapy devices are mostly home appliance enterprises. Due to multiple factors such as the epidemic and the implementation of relevant standards, the time for product inspection and clinical trials has been extended, and the preparation and supplement of product registration and application materials still need some time.

On the basis of fully listening to the opinions of industry organizations and enterprises, combined with the actual research and development of products, and taking into account the safety of public use of medical devices and the needs of orderly industrial development, the National Medical Products Administration has issued Announcement No. 84, clarifying that from April 1, 2026, products such as radiofrequency therapy devices and radiofrequency skin therapy devices in the 09-07-02 radiofrequency therapy (non ablation) equipment attached to Announcement No. 30 that have not obtained a medical device registration certificate in accordance with the law shall not be produced, imported, or sold.

The announcement of the extension of the new regulations also shows: "For those who have obtained the registration certificate for Class II medical devices, the original registration certificate will continue to be valid during the validity period. If the original registration certificate expires before April 1, 2026, the registrant can apply for an extension of the original registration certificate to the original approval department, and the maximum extension period shall not exceed March 31, 2026." However, according to industry insiders, there are very few household beauty devices with Class II medical device registration certificates, usually large medical beauty equipment.

Previously, the new regulations were planned to be implemented from April 1, 2024, and many beauty device brands began clearance sales before this restriction time. A consumer once said that since the end of 2023, the price of Chupu products has "dropped". The original price of the beauty instrument of 3999 yuan is 2199 yuan in the official flagship store, while in the Tiktok promotion, the product is only 699 yuan. In February 2024, Chupu appeared the rumor of "running away" because the official flagship store of Tmall closed and the official WeChat official account was renamed. On February 27th, Chupu responded that this was mainly due to the company changing its general agent in China.

According to the Publicity of Clinical Trial Filing of International Cooperation on Human Genetic Resources in China released by the government affairs service platform of the Ministry of Science and Technology, four household beauty instrument brands, Miguang, Yameng, Huazhi and OGP Shiziji, were put on clinical trial filing in March and April 2023. As of now, no household beauty device brand has obtained a Class III medical device registration certificate.

Plan

On April 1, 2024, the new regulations were officially implemented, and RF home beauty devices had already been taken down one after another. Brands need to obtain certificates to resume work.

The person in charge of the Miguang brand stated that one of the most important goals of the company at present is to obtain a Class III medical device registration certificate for RF products, and the extension of the new regulations will not affect this goal. It also stated that according to the official progress announcement, Miguang is likely to be the first brand to obtain RF certification.

At present, household beauty devices can be divided into radio frequency, microcurrent, laser, and LED (light emitting diode) categories according to technical principles, among which radio frequency is a more important type. Industry insiders explain that RF products entered the market relatively early, with mature technology and sufficient clinical data and research support. There are also many manufacturers launching RF products, and users have a high awareness and acceptance of RF devices. As a result, the market share of RF products is relatively large.

After the announcement of the extension of the new regulations, Economic Observer reporters searched for "RF beauty devices" on Taobao and found that RF products have not yet been relisted.

The brand leader of the above-mentioned head beauty device explained that RF beauty devices were originally used in offline beauty salons and have very high energy, while household beauty devices cannot compare with the energy released by offline beauty salon instruments due to their limited area. After the new regulations were introduced, household beauty devices cannot be sold without reaching radio frequency energy. Currently, most of the household beauty devices on the market belong to microcurrent beauty devices.

The person in charge of the Miguang brand stated that obtaining the RF beauty device certificate is a very important goal for the company, but it is not the only key goal. In addition to beauty devices, Miguang also has other categories such as mirrors, hair removal devices, and skincare products, which existed before the policy was announced.

He added that Micron's philosophy has always been "precision skincare", which is a comprehensive solution that combines energy and ingredients. In addition to radio frequency, the energy here also involves light, heat, EMS (micro current), ultrasound, etc. Light corresponds to phototherapy masks/large row lights, light, heat, and EMS correspond to water cannons, and ultrasound and EMS correspond to ultrasound eggs. The products corresponding to different energy layouts were also planned before the policy was announced. "The strategy and specific strategies for the next step are still under discussion, but the long-term strategy of providing precise skincare solutions based on energy and ingredients will not change."

Compete

After international brands such as Yameng and Chupu entered the Chinese market in 2014, the Chinese home beauty device market experienced rapid growth. Even in 2023 after the introduction of the new regulations, the sales and sales growth of this category will still be rapid during the "Double 11" promotion period on the Tiktok platform, but the transaction price will decline year-on-year. According to statistics from third-party organizations, online sales of beauty devices in the first quarter of 2024 decreased by 32% year-on-year.

Chen Liang believes that obtaining certification may not necessarily be the most important goal for brands at present, 'survival' is the key. At present, the competition in the field of home beauty devices is very fierce, and the key factor is the relatively low technological barrier.

The currently popular products on the market, such as "collagen cannon", "big iron", and "big row lamp", use technology principles different from radio frequency.

According to the relevant person in charge of Miguang brand, "Collagen Cannon" is a technical concept proposed by Miguang, which belongs to a new use mode of RF (from sliding use with gel to sealing use with lattice facial mask). Later, other brands followed this category. Generally, "collagen gun" refers to "RF instrument used with grid facial mask for sealing". The "Big Iron" is a product launched by Jimeng, which initially belonged to the category of radiofrequency devices. Because the head looks like an iron, it was called the "Big Iron". Later, other brands also began to launch "Big Iron" beauty devices without radiofrequency. The "large row lights" use the more mainstream LED light source. Both Jimeng and Xiyou brands have launched the "Da Pai Deng" beauty device.

After experiencing low prices and large inventory, Chupu's products have returned to high prices. In March 2024, Chupu launched a new product called "Plastic Gold Carving Knife" with a price of 6999 yuan, which is generally higher than the industry average. As for why the pricing is so high, Chupu customer service personnel said that the product adopts integrated sound, light and electricity technology, involving E-choTech echo technology, LED red light technology, and full current technology, which is more comprehensive and efficient in technology. But Chen Liang said that the barriers to entry for these technologies are not high.

He stated that the beauty device market, like other non essential consumer goods industries, has experienced a decline in scale, with multiple brands facing operational pressure and even experiencing widespread losses. Although LED beauty devices are a new direction, LED itself has extremely low technical barriers, serious homogenization, and significant "involution". The future market opportunity lies in cost-effective products with precise effects and lower prices.

Internet celebrity brand Miguang has also been rumored to be bankrupt recently. On July 7th, Miguang responded that the company's business operations are stable and there are no operational issues; The company's routine organizational adjustments related to business restructuring have no impact on products, services, business cooperation, etc., and all business activities are progressing in an orderly manner. As for the specific routine organizational adjustments, as of the time of writing, Miguang has not provided a response.

This article is from the WeChat official account: Economic Observer (ID: eeo com cn), written by Xie Chuchu

This content is the author's independent viewpoint and does not represent the stance of Tiger Sniff. Reproduction without permission is not allowed. Please contact for authorization matters hezuo@huxiu.com. If you have any objections or complaints about this article, please contact tougao@huxiu.com.

新规延期两年,家用美容仪行业能“回春”吗?

经济观察报

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本文来自微信公众号:经济观察报(ID:eeo-com-cn),作者:谢楚楚,题图来自:视觉中国


家用美容仪行业又多了两年窗口期。

2022年3月,国家药监局调整《医疗器械分类目录》内容,明确射频治疗仪、射频皮肤治疗仪类产品纳入三类医疗器械目录管理,当时市面上所有家用美容仪均按照小家电标准进行管理,但标准不具有强制性。从那时起,不少头部品牌为继续销售射频类产品已开始筹备三类医疗器械的备案。按照新政策,厂家若无法获得三类医疗器械注册证,就不得出售美容仪。新政实施时间为2024年4月1日。

随着限令时间逼近,美容仪市场出现了大甩卖现象,原价3000多元的产品降至几百元,厂家也纷纷下架射频类产品。快速增长的家用美容仪行业从野蛮生长时代进入了监管时代。

但正当品牌们为重新获得销售资格、调整业务方向而奔波时,它们又重新获得了政策窗口期。7月8日,国家药监局发布的《关于进一步明确射频治疗仪类产品有关要求的公告》显示,自2026年4月1日起,《关于调整〈医疗器械分类目录〉部分内容的公告》(2022年第30号)附件中09-07-02射频治疗(非消融)设备中的射频治疗仪、射频皮肤治疗仪类产品,未依法取得医疗器械注册证的,不得生产、进口和销售。

对于新规实施又多了两年窗口期一事,7月10日,觅光品牌相关负责人对经济观察报表示:“我们还在和相关部门了解政策具体的细节,具体应对策略没有那么快出来。最近老板们和产品研发部门的同事也在研讨中。”一位不愿具名的头部美容仪品牌负责人称,新公告对所有品牌来说都“很突然”。

资深美容仪行业专家、前TriPollar初普中国区品牌主理人陈亮对经济观察报表示,新规延期意味着市场主管部门多给了射频美容仪品牌两年喘息机会,以筹备医疗器械注册。但他认为,拿证未必是品牌们当前的首要任务,在消费能力整体下滑的背景下,各品牌的**要务是“活过寒冬”。

延期

对于新规的突然延期,上述头部美容仪品牌负责人表示,包括自己在内的绝大部分品牌均还处于对消息的了解阶段,无法给出是否重新上线射频类产品的确切信息,“大部分企业的业务布局(节奏)都被打乱了”。

觅光品牌相关负责人称,从国家药监局发布的文件看,射频类产品重新售卖应该是被获许的,但具体有哪些要求?和之前的规定有什么区别?目前还在了解中。而关于是否重新上线射频类产品的后续安排,该公司还在研究中。

国家药监局在对新规延期公告的解读中称:现阶段,手持式射频治疗仪、射频皮肤治疗仪的注册申请人多为家电企业,受疫情、有关标准实施等多重因素影响,产品检验、临床试验时间拉长,产品注册申报准备和资料补充还需一定的时间。

在充分听取行业组织及企业意见基础上,结合产品研发实际,统筹考虑公众用械安全和产业有序发展需要,国家药监局发布84号公告,明确30号公告附件中09-07-02射频治疗(非消融)设备中的射频治疗仪、射频皮肤治疗仪类产品,自2026年4月1日起,未依法取得医疗器械注册证的,不得生产、进口和销售。

新规延期公告还显示:“已取得第二类医疗器械注册证的,原注册证在有效期内继续有效。原注册证在2026年4月1日前到期的,注册人可向原审批部门提出原注册证延期申请,延长期限最长不得超过2026年3月31日。”但据业内人士透露,目前拥有二类医疗器械注册证的家用美容仪产品极少,一般为大型医美设备。

此前新规计划实施的时间是从2024年4月1日开始的,不少美容仪品牌在此限令时间前夕开始了清仓大甩卖。有消费者曾表示,从2023年年末开始,初普产品的价格出现“跳水”,原价3999元的美容仪在官方旗舰店卖2199元,而在抖音促销活动中,该产品仅卖699元。2024年2月,初普因天猫官方旗舰店关店、官方微信公众号更名而出现“跑路”传闻。2月27日,初普回应称,这主要是由于该公司更换了中国区总代理商。

根据科学技术部政务服务平台公布的《中国人类遗传资源国际合作临床试验备案情况公示》,觅光、雅萌、花至和OGP时光肌四个家用美容仪品牌在2023年3月、4月进行了临床试验备案。截至目前,尚未有家用美容仪品牌拿到三类医疗器械注册证。

规划

2024年4月1日,新规正式实施,射频类家用美容仪在此之前已纷纷下架,品牌们需拿证重新上岗。

觅光品牌相关负责人表示,当前该公司最重要的目标之一是拿到射频类产品三类医疗器械注册证,新规的延期并不会影响这一目标。其还称,根据官方公布的进度,觅光很有可能是**家拿到射频类证书的品牌。

目前家用美容仪按技术原理可分为射频类、微电流类、激光类和LED(发光二极管)类等,其中,射频类是较为重要的一种。有业内人士解释,射频类产品进入市场比较早,技术成熟,有足够的临床数据、论文支撑,也有较多厂商推出射频类产品,用户对射频仪的认知和接受度比较高。由此,射频类产品的市场份额相对较大。

在新规延期消息发布后,经济观察报记者在淘宝网搜索“射频美容仪”后发现,射频类产品尚未重新上架。

上述头部美容仪品牌负责人解释,射频类美容仪最初由线下美容院使用,能量非常大,而家用美容仪由于面积限制,无法与线下美容院仪器释放的能量相比。新规出台后,家用美容仪没有达到射频能量就不能售卖,目前市面上大部分在售的家用美容仪器都属于微电流美容仪。

觅光品牌相关负责人表示,拿到射频美容仪证是该公司非常重要的目标,但并不是**重点目标。除了美容仪,觅光还有镜子、脱毛仪、护肤品等其余品类,这些品类在政策公布前就已经存在。

他补充道,觅光一直的理念是“精准护肤”,也就是能量和成分结合的综合解决方案。除了射频之外,这里的能量还涉及光、热、EMS(微电流)、超声等,光对应光疗面罩/大排灯,光、热和EMS对应水光炮,超声和EMS对应超声蛋。不同能量布局对应的产品,这也是在政策公布之前就开始的规划,“关于下一步的战略、具体策略还在讨论中,但做能量+成分的精准护肤解决方案这个长期战略是不会变的”。

竞争

雅萌、初普等国际品牌于2014年进入中国市场后,中国家用美容仪市场获得了快速增长。甚至在新规出台后的2023年,该品类在抖音平台“双十一大促”期间的销售额、销量增速依旧迅猛,不过,其成交价格同比出现下降。根据第三方机构统计数据,2024年**季度美容仪品类线上销量同比下降32%。

陈亮认为,拿证未必是品牌们当下最重要的目标,“活下来”才是。目前家用美容仪赛道竞争十分激烈,其关键因素在于技术壁垒相对较低。

目前市面上较为热门的产品“胶原炮”“大熨斗”“大排灯”,采用了区别于射频的技术原理。

据觅光品牌相关负责人介绍,“胶原炮”是觅光提出的技术概念,属于射频的一种新使用方式(从搭配凝胶滑动使用,改成搭配格子面膜盖章使用),后来其他品牌跟进了这一品类。一般情况下,“胶原炮”指的是“搭配格子面膜盖章使用的射频仪”。“大熨斗”是极萌推出的产品,一开始也属于射频仪,因为头大像一个熨斗,被叫做“大熨斗”,后续其他品牌也开始陆续推出不含射频的“大熨斗”美容仪。“大排灯”则采用的是较为主流的LED光源。极萌和昔又两个品牌均推出了“大排灯”美容仪。

初普的产品经历了低价大清仓后,又恢复了高价。2024年3月,初普推出的新品“塑颜金刻刀”,售价为6999元,普遍高于行业平均水平。对于为何定价如此之高,初普客服人员表示,该产品采用了声光电一体技术,涉及E-choTech回声技术、LED红光技术、全电流技术,技术更全面、更多效。但陈亮称,这些技术的壁垒并不高。

他表示,美容仪市场与其他非必需消费品行业一样,规模下滑,多家品牌存在经营压力,甚至出现了大面积亏损。LED美容仪虽然是一个新的方向,但LED本身技术壁垒极低,同质化严重,“内卷”相当严重。未来的市场机会则在于效果确切、价格更低的高性价比产品。

网红品牌觅光也于近期陷入“破产”传言。7月7日,觅光回应称,该公司业务运行稳健,并无任何经营问题;该公司与业务调整相关的常规组织调整,对产品、服务、商务合作等均无任何影响,各项业务均有序推进。而对于具体是怎样的常规组织调整,截至发稿,觅光方面并未作回复。

本文来自微信公众号:经济观察报(ID:eeo-com-cn),作者:谢楚楚

本内容为作者独立观点,不代表虎嗅立场。未经允许不得转载,授权事宜请联系hezuo@huxiu.com。如对本稿件有异议或投诉,请联系tougao@huxiu.com。

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