From the foreskin ring to the strong pulse light hair removal instrument from the nasal clip to the snoring device to the tonic material
● Foreskin ring cutters, strong pulse light hair removal instruments, nasal crickets and snoring versions … At present, many medical devices can be purchased through e -commerce platforms, and many e -commerce companies have unknown products. Irregular issues such as qualifications and risk -free prompts
● Not all medical devices can be used by themselves. For self -use, its product instructions should comply with the special provisions of the medical device instructions and label management, and the special instructions for marking safe use. The product registration certificate or instruction manual indicates that “only medical institutions use”, etc. It is not recommended that consumers buy themselves
● The provider of the third -party platform of the medical device network transaction service shall monitor the sales behavior and information of the medical device on the platform, and find that there is an illegal violation of laws or other serious security risks in the discovery of the company. Report
A few days ago, a report aroused widespread concern in the society -a man in Shenzhen, Guangdong was busy at home due to the busy work and the online shopping foreskin. In an interview, the doctor said that improper cutting operation was risk of necrosis.
According to an interview with the “Rule of Law Daily”, the foreskin ring is a surgical device, which belongs to the second type of medical equipment, and is sold on major e -commerce platforms. Not only is the foreskin ring, at present, many medical devices can be purchased through e -commerce platforms, and many e -commerce companies have unknown the products sold as medical devices, no related business qualifications, and non -risk prompts.
What are the risks of medical devices that can be placed one -click, which legal regulations may be violated, and how can we regulate this field?
Just talk about operations convenient, no risk
Call the medical device as a beauty instrument
The reporter searched for a “foreskin ring” on an e -commerce platform, jumped out of a large number of related products, and the same “wolf and foreskin ring suture” purchased with the above men. When merchants promote these foreskin circles, they generally use promotional words such as “you can solve the foreskin”, “convenient operation”, “convenient operation”, “convenient operation”.
The reporter checked the “details” page of multiple products and found that the merchants did not explicitly indicate that the foreskin cycle was medical equipment, no risk prompts, and no relevant qualifications to operate such products. There is also a customer service when receiving the reporter’s consultation, which is denied that this is a medical device, so that the reporter can rest assured to buy and use it.
Seeing a well -selling foreskin ring, when the reporter consulted how to use customer service, the customer service replied: “This medical device is sold to the doctor, and it cannot be used by individuals.” And there is no prompt used by the doctor on this product page. Essence
Like the foreskin ring, there are medical devices such as nasal clip clipstomers and laser hair removal instruments.
The customer service of an online store told reporters: “The working principle of the nasal nasal stopper is to put the anthriggling device into the nasal cavity. After the airway is expanded, the airflow passes through the throat and soft palate to reduce the vibration and vortex of the suspended Yongchi. So as to reduce or eliminate snoring. “
The “details” page of this product does not have a medical device registration certificate number. The reporter asked the customer service, and the customer service also said that this is not a medical device.
In fact, the “Catalog of Medical Device” clearly states that through expansion of nasal cavity, upper and lower jaws, or correction of it, the stopper and ventilation nose stickers that improve the snoring status or expand the nostril belong to the second category of medical devices.
In the spring season, many merchants and Internet celebrity bloggers have begun to recommend netizens to buy semiconductor laser hair removal instruments, strong pulse light hair removal instruments. It is recommended by the ground, but few merchants and bloggers informed netizens: This is medical device.
The reporter’s inquiry “Medical Device Classification Catalog” learned that the semiconductor laser hair removal instrument is a laser therapy equipment and is the third category of medical equipment, and the strong pulse light hair removal instrument is the second type of medical equipment.
As early as May 2018, the State Drug Administration issued the “Notice of Defining the Classification of Strong Pulse Light Hair Products”, which stated that strong pulse light hair removal products were managed by the second category of medical equipment.
An e -commerce platform’s official flagship store is selling a household hair removal instrument. The product introduction states that the IPL pulse light technology is used. The customer service introduces the product to the FDA certification, that is, the US Food and Drug Administration Red Health. When the reporter was asked if the hair removal instrument was a medical device, the customer service said: “Not medical equipment, but a beauty instrument.”
“Beauty instruments.” This is the merchant almost consistently responded when the reporter consults the semiconductor laser hair removal instrument and a strong pulse light hair removal instrument and a strong pulse light removal instrument.
“Strong pulse light hair removal products are the second type of medical equipment according to the” Catalog of Medical Device Classification “. This is not a denying of a merchant. If there is no qualified enterprise to sell such products, the food and drug supervision and management department can sell or overshoot according to unlicensed or oversupply. The scope operation is punished, “said Deng Liqiang, deputy director of Beijing Huawei Law Firm.
High -risk instruments online sales
The store is unwilling to show a license certificate
Oral health is a thing that Volkswagen has been particularly concerned in recent years, and the high costs incurred by “watching teeth” have made many people discourage. In order to save money and save money, many consumers choose to buy tonic materials online at home.
The reporter searched for “replenishment” on the e -commerce platform, and a large amount of materials used for replenishment appeared. Merchants promote the safety and non -toxic of products, lasting stickiness, packets and simple operations, which can make consumers a “temporary replenishment expert”.
Taking the dental supplementary dental cavity materials sold by a medical device specialty store as an example of a medical device specialty store as an example, the price ranges between 24 yuan and 350 yuan. In the product “details” page, the merchant briefly introduces the steps of self -made tooth. It is to clean up teeth, harmonious materials, fill holes, and solidify. If you need to operate the video, you can contact the customer service.
The reporter consulted the customer service: “The main component of the material is glass ion Shuimin Ting, which is safe and harmless.” The reporter found on the official website of the State Drug Administration that glass ion door is a third category of medical devices.
It is reported that the current classification management of medical devices is divided into three categories: the first category is the low degree of risk, and the implementation of conventional management can ensure its safety and effective medical equipment. Its safety and effective medical devices; the third category is that it has high risks and requires special measures to strictly control management to ensure its safety and effective medical equipment.
According to the “Regulations on the Supervision and Administration of Medical Device”, if they are engaged in the operation of the third category of medical device, the operating enterprise shall apply to the municipal -level people’s government in which the municipal -level people’s government is in charge of the drug supervision and management department and submit relevant information. In other words, selling the third category of medical devices requires a business license.
The reporter did not find the relevant qualifications of the merchant on the online page of the specialty store, so he asked if the customer service had relevant qualifications and could it be provided? Customer service reporters “whether to buy materials to replenish their teeth”, and then ignored the reporters. There are comments in the product review area saying: “The praise is brushed out, and the quality is very poor.”
“Merchants announced the real product information when selling medical devices is the obligation stipulated in the” Measures for the Supervision and Administration of Medical Device Network Sales Supervision “. At the same time, the e -commerce law stipulates that if e -commerce operators send advertisements to consumers, they shall abide by the relevant provisions of the advertising law Otherwise, we must bear the corresponding responsibilities, “Deng Liqiang said.
The resident platform shall register the real name
Strictly implement administrative license filing
The reporter found in the investigation that most merchants did not show the sales qualifications of medical devices, and the information of related products was not complete.
According to the “Measures for the Supervision and Administration of Medical Device Network Sales”, enterprises engaged in online sales of medical device should display their medical device production and operation licenses or filing vouchers on their homepage. Certificate or filing voucher. The relevant display information should be clear and easy to identify. Among them, the number of medical device production and operation licenses or filing vouchers, medical device registration certificates or filing vouchers shall also be displayed in text.
In this regard, Professor Jie Zhiyong, a professor of China University of Political Science and Law, said that whether it is online or offline sales of medical devices, they should follow the relevant provisions such as the “Regulations on the Supervision and Administration of Medical Device” and the “Measures for the Supervision and Administration of Medical Device Management”. “Measures for the Supervision and Administration of Medical Devices” and relevant regulations of the e -commerce law. “If the merchant is not in place to publicize the registration information or the filing information, it is illegal.”
Deng Liqiang said that medical equipment is a special commodity. The purpose of producing and selling secondary and third categories of medical devices to obtain administrative licenses or filing is to protect consumers’ right to life and health, and it must be strictly implemented.
Regarding the obligations and responsibilities of the e -commerce platform, Dun Liqiang said that the provider of the third -party platform provider of the medical device network transaction service should monitor the sales behavior and information of the medical device on the platform. If an illegal act or other serious security hazards such as exaggerating publicity or other serious security hazards shall immediately stop online transaction services, and save relevant records to report to the provincial food and drug supervision and management department of the local area.
“As a third -party platform, real -name registration shall be registered when allowing medical device registered, recorder or medical device operating enterprise to settle in the platform, and review the instrumental information, and immediately report law enforcement agencies to find illegal acts.” Deng Liqiang said.
Not all equipment can be used by themselves
Interests can protect their rights in accordance with the law
Dazzling medical equipment on the Internet, what should consumers pay attention to and how to avoid risks?
Deng Liqiang gave two suggestions: First of all, consumers must pay attention to not all medical devices can be used by themselves. For self -use, its product instructions should comply with the special provisions of the medical device instructions and label management, and the special instructions for marking safe use. The product registration certificate or instructions indicate that “the use of only medical institutions”, “prohibited to be worn by non -prescription”, “should be used by professional training in specific environments” and other prompts. It is not recommended that consumers buy themselves.
Secondly, consumers must look at the “three certificates” for medical device online, that is, to see medical device product certificates. Medical device products must obtain medical device registration certificates or filing vouchers in accordance with the law. Consumers can log in to the website of the State Drug Administration website “Data Query” Inquiring about the relevant information of the medical device in the “Medical Device” column; depending on the production enterprise documents, the production of medical device production licenses and filing vouchers must be obtained; depending on the business documents, the third type of medical device operation needs to obtain medical device business license The second type of medical device operation requires obtaining a document for business filing.
If consumers buy unqualified medical devices, Dun Liqiang suggested that rights in accordance with the following ways to defend their rights according to law:
When buying medical equipment, you must ask for a shopping invoice. The formal invoice is a purchase voucher. It is very useful in product warranty and quality complaints. Enterprises that illegal sales often have no formal notes;
If you purchase unqualified medical devices without use or use it, it does not cause harm, you can directly find a merchant claim according to the Consumer Rights Protection Law, or you can protect your rights through the local consumer association;
If you purchase and use the medical device and cause damage, you need to save relevant evidence, such as medical records, invoices, disability reports, etc., it is best to have an appraisal report for use and damage, and choose a lawsuit to defend your rights.
“The fundamental purpose of formulating laws and regulations to manage medical device management activities is to ensure the legitimate rights and interests of consumers. Consumers should take the initiative to inquire about the relevant qualifications of the company. Only consumers and operators and regulators work together. Online shopping can develop healthily. “Deng Liqiang said. Comic/Gao Yue
On March 30, the State Drug Administration issued the “Announcement on Adjusting the” Part of the Catalog of Medical Device “(hereinafter referred to as the” Announcement “), which adjusted the content of the” Catalog of Medical Device “of 27 categories of medical devices. The adjustment content announced this time includes some medical cosmetic products, which are as follows:
1. RF therapy instrument and radio frequency skin therapy instrument, used to treat skin relaxation, reduce skin wrinkles, shrink pores, tighten, improve skin tissue, or treat acne, scars, or reduce fat (fat softening or decomposition), etc. Class III medical device supervision.
2. Facial planting lines, facial lifting lines, and facial cone tip lines are used to implant facial tissue to enhance the sagging tissue and correct wrinkles.
3. Injecting sodium hyaluronate solution is used for injection to the dermis layer. It mainly improves the skin condition through the moisturizing and hydrating effects of sodium hyaluronate and other materials.
The “Announcement” states that the above -mentioned medical beauty products are managed in accordance with the medical device and pointed out that except for radio frequency therapy and radio frequency skin therapy instruments, other products are implemented from the date of the release of the Announcement. From the date of implementation, products that have not obtained medical device registration certificates shall not be produced, imported and sold in accordance with the “Regulations on the Supervision and Administration of Medical Device”. (Reporter Han Dandong intern Guan Chuyu)
Source: Rule of Law Daily
Do you dare to use one -click medical equipment?