Medical dressings to sell as masks? "Mechanical brand" product market chaos investigation

Original title: Medical dressings when beauty masks are sold online at will

The reporter investigated the chaos in the market of "mechanical brand" products

● With the rise of e-commerce platforms and live broadcast sales, "mechanical brand" products such as "mechanical font number" masks applied to the face and beautiful pupils worn on the eyes have become increasingly popular in the live broadcast room, which is favored by consumers. But many consumers don't know it's a medical device

● The "mechanical brand" mask is a medical dressing and belongs to the category of medical devices. The naming of medical dressings managed according to medical devices shall comply with the requirements of the "Rules for the Naming of Generic Names of Medical Devices", and shall not contain promotional words such as "beauty" and "health care", and shall not contain exaggerated scope of application or other misleading and deceptive content

● As an advertiser, the platform should pay attention to the fact that the operation of medical devices cannot be falsely publicized or excessively publicized, otherwise it will bear the relevant legal responsibilities for medical treatment and advertising

"This 'mechanical' mask has a better beauty effect than ordinary masks, with a soothing, restorative 'medical aesthetic' effect." On a short video platform, a beauty anchor is "touting" a mask in the live broadcast, saying that it can be used every day, and the price is similar to that of ordinary masks.

The "Rule of Law Daily" reporter noted that after 1 minute of this mask on the shelves, 300 items were robbed. In the message area, almost no one questioned the "machine size", and more people paid attention to the use effect.

The so-called "mechanical brand number" refers to the medical device filing name, and the "mechanical brand number" product refers to the medical device that can ensure its safety and effectiveness by implementing the national conventional management.

In recent years, with the rise of e-commerce platforms and live broadcast sales, "mechanical brand" products such as "mechanical number" masks applied to the face and beautiful pupils worn on the eyes have become increasingly popular in the live broadcast room, which is favored by consumers. However, the reporter's investigation found that many consumers who purchased "mechanical brand" products did not know that they belonged to medical devices and could not be used at will in daily life; some merchants also sold them at will without business qualifications, resulting in frequent chaos in the "mechanical brand" product market.

Mechanical products are medical devices

But many consumers don't know it

Ms. Wu from Jinhua, Zhejiang Province, has been using a medical beauty mask, but she does not feel that this mask is different from other masks, but the appearance is different from other masks - this "mechanical" mask packaging reads "medical sodium hyaluronate repair patch".

"The merchant advertised that this was a 'mechanical brand' mask, but I really didn't know that it was actually a medical device." Ms. Wu said.

Like Ms. Wu, Ms. Li from Yancheng, Jiangsu Province, is also keen to use the "mechanical brand" mask, because she learned from the merchant that this mask "can remove acne, eliminate acne marks, tighten pores, anti-aging, repair sensitive skin..." And these restorative functions are "just needed" for Ms. Li. But she has always thought that this is a "medical beauty mask" and has not equated it with medical devices at all.

The reporter searched for "mechanical mask" on the e-commerce platform and found that most merchants used keywords such as "facial repair film mechanical size" and "beauty mask mechanical size" to describe such products.

As early as January 2020, the then State Drug Administration issued an announcement on "Cosmetics Science Popularization: Vigilance Against mask consumption traps", saying that there is no so-called "mechanical mask" concept.

The announcement pointed out that the "mechanical brand" mask is a medical dressing and belongs to the category of medical devices. The naming of medical dressings managed according to medical devices shall comply with the requirements of the "Rules for the Naming of Generic Names of Medical Devices", and shall not contain promotional words such as "beauty" and "health care", and shall not contain exaggerated scope of application or other misleading and deceptive content. "Mechanical mask" is a concept created by merchants in order to sell, and medical device products cannot use "mask" as their name.

The reporter found that in addition to the "mechanical mask", the three types of products that are hyped up by merchants, such as beauty pupils, medical beauty creams and humanoid collagen, also belong to medical devices. Another name for them is contact lenses, liquid dressings, soluble collagen.

After learning that the beautiful pupil she often uses is actually a contact lens of the cornea, Ms. Wang from Shanghai finally understands the reason why her eyes are often inflamed. She had been buying a foreign brand of beauty pupils before, after using it for a period of time, her eyes were often inflamed, and after going to the hospital for examination, she learned that the cornea was scratched by the beautiful pupil.

In fact, the State Administration for Market Supervision and Administration has long defined color contact lenses as three types of medical devices, and users should first conduct eye examinations, go to optical stores with relevant qualifications to buy large brands and regular color contact lenses, and use them under the guidance of professionals.

Because she did not understand these regulations, Ms. Wang used the beauty pupil as a cosmetic, and often purchased it through e-commerce platforms or offline optical stores, so that the cause of the eye injury is not clear.

There are many ways to sell online

The authenticity of business qualifications raises questions

The reporter searched for keywords such as "medical beauty mask" and "machine name" on some mainstream e-commerce platforms, and found that the pop-up commodity interfaces were all products released by online pharmacies and medical device franchise stores, and these stores also had words such as "through the State Food and Drug Administration filing license certification". However, in some Apps of Tieba and life interactive platforms, when searching for the above keywords, the reporter found some "cat greasy".

The reporter clicked on an "affordable beauty pupil" experience sticker in an App, the content seems to be the blogger's evaluation, and the top of the comment area is the purchase method attached to the blogger, if you want to buy this affordable beauty pupil, you have to privately send a message to the blogger and add its contact information. Below the comment area, there are more than 100 messages, most of which are messages from consumers vying to add blogger contact information, seeking to buy and use feelings.

After the private message blogger, the reporter added the blogger's contact information, and found that the blogger's circle of friends was full of articles similar to affordable beauty pupils, and the copywriting was also roughly similar. The blogger in each copywriting has specially reminded that the beauty pupil is purchased through Japan, South Korea and other places, the supply is in short supply, want to buy quickly.

When asked if he had marketing qualifications, the blogger sent a picture with a coded medical device business license, and the company name, residence, business premises, warehouse address and other information were marked with thick mosaics.

In another store circle of friends called "Good Thing Amway Official", the reporter found that the beauty products it sold also contained medical masks, beauty pupils and other medical devices. After talking, I learned that it was an agent rather than a dealer, and that it was directly picked up from the manufacturer by the upper family, and that it did not have business qualifications.

When the reporter indicated the purchase intention, the other party sent a link, click to enter the interface is very simple, even the product introduction, some of the product names with pinyin instead, the price is also much cheaper than the official website price. The reporter then asked the store whether these products were purchased from regular manufacturers, and then was "blocked" by the store.

Refer to medical devices as cosmetics

The merchant's move is illegal

According to Zheng Ning, director of the Law Department of the School of Cultural Industry Management of the Communication University of China, China applies two sets of regulatory systems for medical devices and cosmetics, and the Regulations on the Supervision and Administration of Medical Devices and the Regulations on the Supervision and Administration of Cosmetics are applied respectively. Merchant sales should be in line with the business scope of the enterprise.

Wang Yue, a professor at the Department of Medical Ethics and Law at Peking University, told reporters that medical devices are divided into one, two and three categories according to the risks of products. Medical device business according to the different types of products, the implementation of classification management, the operation of a class of medical devices do not require license and filing, the operation of the second class of medical devices to implement record management, the operation of the third class of medical devices to implement licensing management.

"After obtaining the medical device business filing certificate, the enterprise can sell the second class of medical devices within the approved scope; after obtaining the medical device business license, the enterprise can sell the third class of medical devices within the approved scope." Wang Yue said.

According to the "Regulations on the Supervision and Administration of Medical Devices", if the merchant is not qualified to sell, the department responsible for drug supervision and management and the competent health department shall order corrections and give a warning according to their respective duties; if they refuse to make corrections, they shall be fined between 10,000 yuan and 100,000 yuan; if the circumstances are serious, they shall be ordered to stop production and business until the original licensing department revokes the medical device registration certificate, medical device production license, and medical device business license, and the legal representative and main responsible person of the illegal unit. The directly responsible supervisor and other responsible personnel shall be fined between 10,000 yuan and 30,000 yuan.

"The naming of medical dressings managed according to medical devices shall comply with the requirements of the "Naming Rules for Generic Names of Medical Devices", and shall not contain promotional words such as 'beauty' and 'health care', and shall not contain exaggerated scope of application or other misleading and deceptive content." If a merchant declares a medical device to be cosmetic, it is illegal. Zheng Ning said.

Zheng Ning believes that e-commerce platform operators that provide services for online transactions of medical devices should register the real-name medical device operators entering the network, review their business licenses, filings, and the registration and filing of the medical device products they operate, and manage their business behavior. Where e-commerce platform operators discover that online medical device operators have violated the provisions of these Regulations, they shall promptly stop and immediately report to the department responsible for drug supervision and management of the districted municipal people's government where the medical device operator is located;

Deng Liqiang, deputy director of Beijing Huawei Law Firm and executive director of the China Health Law Society, reminded that the platform, as an advertiser, should pay attention to the fact that the operation of medical devices cannot be falsely publicized or excessively publicized, otherwise it will bear the legal responsibilities related to medical treatment and advertising.

"In addition to administrative penalties, criminal liability should also be pursued for violators of fictitious advertising content." Relevant platforms should establish a reward reporting mechanism to encourage the public to crack down on false businesses. Government departments should educate consumers to understand which business advertisements are false propaganda and protect them from illegal medical advertisements. Wang Yue said.

For consumers, Deng Liqiang proposed that medical devices will only be used when medical institutions carry out some special treatment of patients, and it is not recommended that consumers use them outside of medical purposes.

"Medical devices often need to be guided by qualified doctors and used in accordance with the correct dosage, can not be used as daily skin care products for a long time, do not buy 'mechanical brand' cosmetics online, if you encounter disputes, you can complain to the Consumer Association." Zheng Ning said.

Source: Rule of Law Daily