From circumcision devices to intense pulsed light hair removal devices, from pince-nez snoring devices to filling materials
Do you dare to use the medical equipment that you place an order with one click?
● Circumcision device, intense pulsed light hair removal device, pince-needle anti-snoring device... At present, many medical devices can be purchased through e-commerce platforms, and many e-commerce companies do not indicate that the products they sell are medical devices and have no related business. Irregular issues such as qualifications and risk-free reminders
● Not all medical devices can be used for personal use.
For self-use, the product instructions shall comply with the relevant regulations on medical device instructions and label management, and special instructions for safe use shall be marked.
The product registration certificate or instruction manual states "for use by medical institutions only", etc. It is not recommended for consumers to purchase for their own use
● Third-party platform providers of medical device online transaction services should monitor the sales behavior and information of medical devices on the platform, and if they find that the settled enterprises have violations of laws and regulations or other serious security risks, they should immediately stop the online transaction services and report to the law enforcement department. Report
□ Our reporter Han Dandong
□ Our intern Guan Chuyu
A few days ago, a report attracted widespread attention from the society. A man in Shenzhen, Guangdong, was busy with work and purchased a circumcision device online to circumcise himself at home. Due to improper operation, he was sent to the doctor for treatment.
When interviewed, doctors said that improper circumcision has the risk of necrosis.
A reporter from the "Rules of Law Daily" interviewed and learned that the circumcision device is a surgical device, which belongs to the second category of medical devices and is sold on major e-commerce platforms.
Not only circumcision devices, but at present, many medical devices can be purchased through e-commerce platforms, and many e-commerce companies have irregularities such as not indicating that the products they sell are medical devices, no relevant business qualifications, and no risk warnings.
What are the risks of medical devices that can be ordered with one click, what legal regulations might they violate, and how to regulate this field?
Only talk about convenience, not risk
Call medical equipment a beauty instrument
The reporter searched for "circumcision" on an e-commerce platform, and jumped out a large number of related products, as well as the same "wolf and circumcision suture" purchased by the above-mentioned man.
When merchants promote these circumcisions, they generally use slogans such as "the foreskin can be solved without cumbersome surgery", "easy to operate", and "no pain and no feeling when operating by yourself".
The reporter checked the "details" pages of multiple products and found that the merchants did not expressly indicate that the circumcision device is a medical device, nor did they have any risk warnings, nor did they show the relevant qualifications for operating such products.
There are also customer service who denied that it was a medical device when they were consulted by reporters, so that reporters could buy and use with confidence.
Seeing a circumcision device that sells well, when the reporter asked the customer service how to use it, the customer service replied: "This medical device is sold to doctors and cannot be used by individuals." There is no hint on the product page for doctors to use .
Like the circumcision device, which sells well on the Internet, there are also medical devices such as pince-nose anti-snoring device and laser hair removal device.
The customer service of an online shop told reporters: "The working principle of the pince-nephin anti-snoring device is to put the anti-snoring device into the nasal cavity. After the airway is expanded, the airflow passes through the throat and soft palate to make the vibration and vortex generated by the uvula to reduce breathing blockage. Thereby reducing or eliminating snoring."
There is no medical device registration certificate number on the "details" page of the product. The reporter asked the customer service about this, and the customer service also said: This is not a medical device.
In fact, the "Classification Catalog of Medical Devices" makes it clear that anti-snoring devices and ventilation nasal stickers that can improve snoring or dilate the nostrils by expanding the nasal cavity, the upper and lower jaws, or correcting them belong to the second category of medical devices.
In the spring season, many merchants and Internet celebrity bloggers began to recommend netizens to buy semiconductor laser hair removal devices and intense pulsed light hair removal devices. They are meticulous in terms of price, hair removal cycle, hair removal technology, gear function and use experience of the hair removal device. It is highly recommended, but few businesses and bloggers tell netizens: This is a medical device.
The reporter inquired about the "Classified Catalogue of Medical Devices" and learned that the semiconductor laser hair removal device belongs to the laser treatment equipment, which is the third type of medical device, while the intense pulsed light hair removal device is the second type of medical device.
As early as May 2018, the State Drug Administration issued the "Notice on the Classification and Definition of Intense Pulse Light Hair Removal Products", indicating that intense pulse light hair removal products are managed as second-class medical devices.
The official flagship store of a brand on an e-commerce platform is selling a home hair removal device. The product introduction says that it uses IPL pulsed light technology.
When asked by reporters whether the hair removal device is a medical device, the customer service said: "It's not a medical device, it's a beauty device."
"Beauty equipment." This is the almost unanimous reply of the merchants when the reporter inquired about the semiconductor laser hair removal device and the intense pulsed light hair removal device on multiple e-commerce platforms.
"Intense pulsed light hair removal products are Class II medical devices according to the "Classification Catalog of Medical Devices", which cannot be denied by merchants. If unqualified companies sell such products, the food and drug administration can sell them as unlicensed or over-the-counter products. Scope management will be punished.” said Deng Liqiang, deputy director of Beijing Huawei Law Firm.
Online sales of higher risk devices
The store is reluctant to show the permit
Oral health has been a matter of particular concern to the public in recent years, and the high cost of "visiting the teeth" has discouraged many people.
For convenience and saving money, many consumers choose to buy filling materials online to fill their teeth at home.
The reporter searched for "filling teeth" on the e-commerce platform, and a large number of materials for filling teeth appeared.
Merchants advertise that the products are safe, non-toxic, lasting, and easy to operate, allowing consumers to become "temporary filling experts".
Take the dental filling material matching set sold by a medical equipment store on an e-commerce platform as an example. It is cleaning teeth, blending materials, filling cavities and solidification.
If you need to operate the video, you can contact customer service.
The reporter consulted the customer service and learned: "The main component of this material is glass ionomer cement, which is safe and harmless." The reporter inquired on the official website of the State Drug Administration and learned that glass ionomer cement belongs to the third category of medical devices.
It is reported that at present, medical devices are subject to classified management and are divided into three categories: the first category is medical devices with low risk, and routine management can ensure their safety and effectiveness; the second category is moderate risk, which requires strict control and management to ensure Its safe and effective medical devices; the third category is the medical devices with higher risks that require special measures to be strictly controlled and managed to ensure their safety and effectiveness.
According to the "Regulations on the Supervision and Administration of Medical Devices", if engaging in the business of Class III medical devices, the business enterprise shall apply for a business license and submit relevant materials to the department in charge of drug supervision and administration of the people's government of the city divided into districts where it is located.
That is to say, the sale of Class III medical devices requires a business license.
The reporter did not find the relevant qualifications of the merchant on the online page of the franchise store, so he asked the customer service if they had relevant qualifications and whether they could provide them?
The customer service asked the reporter, "Did you come to buy materials to fill the teeth?", and then ignored the reporter.
A comment in the product comment area said: "The praise is brushed out, and the quality is very poor."
"It is the obligation of merchants to publish real product information when selling medical devices. The "Measures for the Supervision and Administration of Online Sales of Medical Devices" stipulates. At the same time, the E-commerce Law stipulates that e-commerce operators who send advertisements to consumers shall abide by the relevant provisions of the Advertising Law. Otherwise, you will bear the corresponding responsibility." Deng Liqiang said.
The platform should be registered with real name
Strictly implement administrative license filing
During the investigation, the reporter found that most businesses did not display the sales qualifications of medical devices, and the information on related products was incomplete.
According to the "Measures for the Supervision and Administration of Online Sales of Medical Devices", an enterprise engaged in online sales of medical devices shall display its medical device production and operation license or filing certificate in a prominent position on its main page, and the product page shall display the medical device registration of the product. certificate or record certificate.
The relevant display information should be clear and easy to identify.
Among them, the number of the medical device production and operation license or filing certificate, medical device registration certificate or filing certificate shall also be displayed in text form.
In this regard, Xie Zhiyong, a professor at China University of Political Science and Law, said that whether online or offline sales of medical devices should follow relevant regulations such as the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Operations, and online sales should also comply with "Measures for the Supervision and Administration of Medical Devices Network", E-commerce Law and other relevant regulations.
"If the business does not publicize the registration information or filing information in place, it is an illegal act."
Deng Liqiang said that medical devices are special commodities, and the purpose of obtaining administrative licenses or filings for the production and sale of Class II and Class III medical devices is to protect consumers' right to life and health, which must be strictly implemented.
Regarding the obligations and responsibilities of the e-commerce platform, Deng Liqiang said that third-party platform providers of medical device online transaction services should monitor the sales behavior and information of medical devices on the platform, and found that the settled enterprises have operations beyond the scope, publishing false information, etc. Those who violate laws and regulations such as exaggerated propaganda or have other serious security risks shall immediately stop online transaction services for them, keep relevant records, and report to the local provincial food and drug supervision and administration department.
"As a third-party platform, when allowing medical device registrants, filers or medical device operating companies to enter the platform, real-name registration should be carried out, and device information should be reviewed, and any illegal acts should be reported to the law enforcement agencies immediately." Deng Liqiang said.
Not all equipment is available for personal use
Rights infringed can be protected according to law
With the dazzling online sales of medical devices, what should consumers pay attention to and how to avoid risks?
Deng Liqiang gave two suggestions: First, consumers must pay attention that not all medical devices can be used for their own use.
For self-use, the product instructions shall comply with the relevant regulations on medical device instructions and label management, and special instructions for safe use shall be marked.
If the product registration certificate or instruction manual states "only for use in medical institutions", "prohibited to wear without a prescription" and "should be used by professionally trained personnel in a specific environment", it is not recommended for consumers to purchase and use.
Secondly, consumers must look at the "three certificates" when purchasing medical devices online, that is, medical device product certificates. Medical device products must obtain a medical device registration certificate or filing certificate in accordance with the law. Consumers can log on to the website of the State Drug Administration. In the "Medical Devices" column, you can inquire about the relevant information of medical devices; look at the production enterprise certificate, the production of medical devices requires a medical device production license and a record certificate; look at the operating enterprise certificate, the third-class medical device operation requires a medical device business license , the second-class medical device business needs to obtain a business record certificate.
If consumers buy unqualified medical devices, Deng Liqiang suggests protecting their rights in accordance with the law in the following ways:
Be sure to ask for a shopping receipt when purchasing medical equipment.
The official invoice is the proof of purchase, which is very useful in product warranty and quality complaints. Enterprises that sell illegally often do not have official invoices;
If you purchase a substandard medical device and do not use it or use it without causing harm, you can directly file a claim with the merchant according to the Consumer Rights Protection Law, or you can protect your rights through the local consumer association;
If you buy and use the medical device and cause injury, you must save relevant evidence, such as medical records, invoices, disability reports, etc.
"The fundamental purpose of the state to formulate laws and regulations to manage medical device business activities is to ensure the legitimate rights and interests of consumers. Before purchasing related products, consumers should take the initiative to inquire about the relevant qualifications of enterprises. Only consumers, operators and regulators work together to Only online shopping can develop healthily." Deng Liqiang said.
News link
On March 30, the State Drug Administration issued the "Announcement on Adjusting Some Contents of the "Medical Device Classification Catalog" (hereinafter referred to as the "Announcement"), adjusting the contents of the "Medical Device Classification Catalog" for 27 types of medical devices.
The adjustment content announced this time includes some medical beauty products, as follows:
1. Radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus are used to treat sagging skin, reduce skin wrinkles, shrink pores, tighten and enhance skin tissue, or treat acne, scars, or reduce fat (fat softening or decomposition), etc. Class III medical device supervision.
2. Facial implantation thread, facial lifting thread, and facial cone threading thread are used to implant facial tissue to lift sagging tissue and correct wrinkles, all of which are regulated in accordance with Class III medical devices.
3. Sodium hyaluronate solution for injection is used for injection into the dermis layer, mainly through the moisturizing and hydrating functions of the contained sodium hyaluronate and other materials to improve the skin condition. These are clearly regulated in accordance with Class III medical devices.
The "Announcement" clarifies that the above-mentioned medical beauty products are managed in accordance with medical devices, and it is pointed out that except for the radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus, other products are implemented from the date of the "Announcement".
From the date of implementation, according to the "Regulations on the Supervision and Administration of Medical Devices", products that have not obtained a medical device registration certificate according to law shall not be produced, imported or sold.