Do it yourself？ Be careful about online shopping for medical devices.

　　Household medical devices sell well and become one of the pillars of pharmacy performance.

　　Consumers "place an order with one click" to purchase medical devices online? A little carelessness may lead to risks. According to media reports, a man recently bought a circumcision device online, and he was eventually sent to hospital for treatment because of his improper operation. The reporter visited a number of e-commerce companies and found that there are different brands and different prices of such products on sale in the market, but the stores have different attitudes towards the instructions and risk warnings of such medical device products. In this regard, some insiders reminded that the e-commerce platform has irregular problems such as unclear products for medical devices, no relevant business qualifications and risk-free tips. Consumers should be more vigilant when shopping online.

　　Text/Figure Guangzhou Daily All-Media Reporter Tu Duanyu Wenjing

　　Case: There are safety risks in surgical instruments at home.

　　A few days ago, a report aroused social concern — — A man in Shenzhen, Guangdong Province, was busy with his work. He circumcised himself at home by online shopping, and was sent to hospital for treatment because of improper operation, which caused bleeding in his lower body. The doctor reminds: Improper self-circumcision has the risk of necrosis. Although this kind of surgery is minor in medicine, it does not mean that ordinary people can do it at home. It has certain safety risks and may be accompanied by bleeding, wound infection and abnormal appearance. It is necessary to go to a regular hospital for professional treatment.

　　It is reported that the circumcision device is a surgical instrument, which belongs to the second category of medical devices and is sold on all major e-commerce platforms.

　　Reporters in JD.COM, Taobao, Pinduoduo and other mainstream e-commerce platforms found that the price of circumcision is mostly in the range of 100~300 yuan. When the reporter consulted an online shop, the customer service said: "There is no risk"; The customer service of another online shop stressed: "We are fully qualified and can deliver goods at any time", but it did not show relevant qualification certificates. The page of an online shop on the shopping platform indicates: "This product is only used by professional doctors and medical institutions, and ordinary individual consumers do not deliver it." The customer service told reporters that it is necessary to have a doctor’s license to deliver it. The backstage of another online shop also reminded that this product can only be operated by professional doctors, but when the reporter asked if it could be shipped after being photographed, the customer service said yes.

　　Investigation: Some nose-clip snorers and laser hair removal devices are not clearly defined as medical devices.

　　The reporter browsed the major e-commerce platforms and found that electronic sphygmomanometer, oximeter, oxygen generator, infrared physiotherapy lamp, snorer and sputum aspirator are the main products of online shopping medical devices. In fact, however, the Catalogue of Medical Devices clearly states that snorers, ventilation nasal patches and so on, which can improve snoring or dilate nostrils by dilating nasal cavity, maxilla and mandible or correcting them, belong to the second category of medical devices.

　　The Catalogue of Medical Devices shows that the semiconductor laser hair removal instrument belongs to laser therapy equipment and is the third kind of medical devices, but the intense pulsed light hair removal instrument belongs to the second kind of medical devices. In 2018, National Medical Products Administration issued the Notice on Classification and Definition of High-intensity Pulsed Light Hair Removal Products, indicating that high-intensity pulsed light hair removal products are managed according to Class II medical devices. If an unqualified enterprise sells such products, the regulatory authorities may punish it for unlicensed sales or out-of-range operations.

　　The reporter saw in Taobao that there are many kinds of household intense pulsed light hair removal instruments on sale, including Braun, Philips, Mujin and other big brands.

　　When the reporter asked the customer service of a brand flagship store whether the products on sale belonged to medical devices, the customer service said that this was a household depilation instrument. It is reported that according to the regulations, since January 1, 2023, products of intense pulsed light hair removal may not be produced, imported or sold without obtaining the medical device registration certificate according to law. Some insiders said that home hair removal instruments are mainly sold online, and how to obtain the registration certificate of medical devices is an urgent problem for brand enterprises.

　　National Medical Products Administration: Some medical beauty products are managed by medical devices.

　　According to industry data, the consumption ratio of household medical devices and medical devices in China is about 1: 4 at present, while it is generally about 1: 1 in developed countries. There is a large market space for household medical devices, and the demand scale of household medical devices will continue to grow in the future. A person in charge of a chain pharmacy in Guangzhou told the reporter that household medical devices contributed one-third of the pharmacy’s performance, including blood pressure detectors, blood sugar detectors, electronic thermometers, foot physiotherapy devices and so on.

　　In the face of endless chaos such as product abuse and out-of-range use, China is constantly strengthening supervision and clarifying the "concept" from the source. Just recently, National Medical Products Administration issued the Announcement on Adjusting Some Contents of the Classified Catalogue of Medical Devices to adjust the contents of the Classified Catalogue of Medical Devices for 27 types of medical devices. The adjustment contents announced this time include some medical beauty products, such as RF therapeutic devices and RF skin therapeutic devices, which are clearly regulated according to Class III medical devices; Facial embedding line and facial lifting line shall be supervised according to Class III medical devices. According to the Regulations on the Supervision and Administration of Medical Devices, products that have not obtained the registration certificate of medical devices according to law will not be allowed to be produced, imported or sold.

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

　　It is reported that at present, China implements classified management of medical devices according to the degree of risk. Risks are divided into three categories from low to high:

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

　　The second category is medical devices with moderate risks that need strict control and management to ensure their safety and effectiveness;

　　The third category is medical devices with high risks and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.

　　According to the Regulation on the Supervision and Administration of Medical Devices, those who engage in the operation of Class III medical devices shall apply for a business license and submit relevant materials to the department in charge of drug supervision and administration of the local municipal people’s government with districts. It is the obligation stipulated in the Measures for the Supervision and Administration of Online Sales of Medical Devices to publish true product information when selling medical devices.