Some online medical devices have inconsistent instructions for use, and the qualification certificate is not clear

　　Consumers "one-click order" to buy medical equipment online?

A little carelessness may encounter risks.

According to media reports, a man recently purchased a circumcision device online and was sent to the hospital for treatment due to improper operation of his lower body bleeding.

The reporter browsed many e-commerce companies and found that there are such products of different brands and different prices on the market, but the store owners have different attitudes about the use instructions and risk warnings of such medical device products.

In this regard, some people in the industry reminded that: there are irregular problems such as the lack of indication that the products sold on the e-commerce platform are medical devices, the lack of relevant business qualifications, and the absence of risk warnings. Consumers should be more vigilant when shopping online.

　　Text/Photo by Tu Duanyu Wenjing, an all-media reporter of Guangzhou Daily

　　Case: At-home surgical instruments have safety risks

　　A few days ago, a report aroused social concern - a man in Shenzhen, Guangdong, who was busy at work, purchased a circumcision device online to circumcise himself at home, and was sent to the doctor for treatment due to improper operation that caused continuous bleeding from the lower body.

The doctor reminds: improper operation of self-circumcision has the risk of necrosis.

Although this type of surgery is a minor operation in medicine, it does not mean that ordinary people can perform it at home. It has certain safety risks, and may be accompanied by bleeding, wound infection and appearance deformity. It is necessary to go to a regular hospital for professional treatment.

　　It is reported 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.

　　The reporter searched on mainstream e-commerce platforms such as Jingdong, Taobao, and Pinduoduo and found that the price of circumcision devices is mostly in the range of 100-300 yuan.

When the reporter consulted an online store, the customer service said: "There is no risk"; the customer service of another online store emphasized: "We have complete qualifications and can deliver goods at any time", but they did not show relevant qualification certificates.

An online shop page on the shopping platform stated: "This product is only for professional doctors and medical institutions, and ordinary individual consumers will not ship it if they are photographed."

The backstage of another online store also reminded that this product can only be operated by professional doctors, but when the reporter asked whether it could be shipped after taking pictures, the customer service said yes.

　　Investigation: Some pince-nosed anti-snoring devices, laser hair removal devices, etc. are not expressly identified as medical devices

　　The reporter browsed major e-commerce platforms and found that electronic sphygmomanometers, oximeters, oxygen generators, infrared physiotherapy lamps, snoring devices, and sputum suction devices are the main products of online shopping of medical devices.

But in fact, the "Medical Device Classification Catalog" clearly states that anti-snoring devices and ventilation nasal stickers that can improve snoring or dilate the nostrils by dilating the nasal cavity, the upper and lower jaws, or correcting them belong to the second category of medical devices.

　　The "Classification Catalog of Medical Devices" shows that semiconductor laser hair removal devices belong to laser treatment equipment and are the third type of medical devices, but intense pulsed light hair removal devices belong to the second type of medical devices.

In 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.

If an unqualified enterprise sells such products, the regulatory authorities can impose penalties as unlicensed sales or out-of-scope operations.

　　The reporter saw on Taobao that there are many household intense pulsed light hair removal devices on sale, including big brands such as Braun, Philips, and Mujin.

　　When the reporter asked the customer service of a flagship store of a brand, whether the product it was selling was a medical device, the customer service said that it was a household-type hair removal device.

It is reported that according to regulations, from January 1, 2023, intense pulsed light hair removal products shall not be produced, imported and sold without obtaining a medical device registration certificate in accordance with the law.

According to industry insiders, household hair removal devices are mainly sold online, and how to obtain a medical device registration certificate is an urgent problem for brand enterprises to solve.

　　State Food and Drug Administration: Some medical beauty products are managed as medical devices

　　Industry data show that the current consumption ratio of domestic medical devices to medical medical devices in my country is about 1:4, while the ratio in developed countries is generally about 1:1. There is a large market space for home medical devices. The scale of demand will continue to grow.

A person in charge of a chain pharmacy in Guangzhou told reporters: Household medical devices contributed 1/3 of the pharmacy's performance, and the best-selling devices include blood pressure monitors, blood sugar monitors, electronic thermometers, and foot physiotherapy devices.

　　In the face of endless chaos such as product abuse and out-of-scope use, my country is constantly strengthening supervision and clarifying the "concept" from the source.

Just recently, the State Drug Administration issued the "Announcement on Adjusting Some Contents of the "Medical Device Classification Catalog", 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, such as: radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus, which are clearly regulated in accordance with Class III medical devices; facial implant lines, facial lifting lines, etc., are subject to Class III medical devices. Supervision.

According to the "Regulations on the Supervision and Administration of Medical Devices", products that have not obtained a medical device registration certificate in accordance with the law will not be allowed to produce, import and sell.

　　Little knowledge: medical devices are divided into three categories according to risk

　　It is reported that my country currently implements classified management of medical devices according to the degree of risk.

Risks are grouped into three categories from low to high:

　　The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management;

　　The second category is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness;

　　The third category is 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.

It is the obligation stipulated in the "Measures for the Supervision and Administration of Online Sales of Medical Devices" for merchants to publish real product information when selling medical devices.