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From April 1, radio frequency beauty devices will usher in strict supervision with a new identity

author:Shandong hot search

During this time, radio frequency beauty devices have a "price reduction tide". What used to cost thousands of dollars is now only a few hundred dollars.

"The world is crazy, the collective price of RF beauty devices has plunged!"

"I bought it for 5000 (yuan), I haven't used it a few times, the price has plunged to 699 (yuan) or even 599 (yuan), I will dive if you dive again!"

"The price reduction has been too big recently, it's simply the floor price!"

From April 1, radio frequency beauty devices will usher in strict supervision with a new identity

Opening the e-commerce platform, the reporter found that on the sales page of the official flagship store of many well-known beauty instruments, the products that were once thousands or even tens of thousands of yuan are now discounted, and some have even fallen below 500 yuan, which not only makes consumers who have purchased it call "heartbreak", but also makes beauty instrument lovers who have been waiting and watching because of the price indulge in "picking up leaks", setting off a trend of "copying the bottom" of beauty instruments on the whole network. And all of this stems from the "Announcement on Adjusting Part of the Classification Catalogue of Medical Devices" (hereinafter referred to as Announcement No. 30) issued by the State Food and Drug Administration in March 2022.

Announcement No. 30 clarifies that radiofrequency therapy devices and radiofrequency skin therapy devices are subject to the management of Class III medical devices, and from April 1, 2024, such products shall not be produced, imported and sold without obtaining a medical device registration certificate in accordance with the law.

Therefore, since many RF beauty devices do not have the registration certificate of Class III medical devices, if you don't want to smash the goods in your hands, you can only clear the inventory as soon as possible before April 1.

Looking back over the years, all the beauty instrument brands have occupied the makeup table of the Chinese people by virtue of their strong marketing. However, behind the consumption of beauty instruments, false product publicity and quality problems occur from time to time. For example, the first-generation Stop Eye home radiofrequency beauty device of Chupu brand has been recalled due to the potential safety hazard of skin burns in extreme cases.

From April 1, radio frequency beauty devices will usher in strict supervision with a new identity
Prior to the implementation of Announcement 30, household RF beauty devices have been managed in accordance with the market standards of "small household appliances", and the relevant standards mainly focus on safety, and there are no relevant standards for the verification of the claimed beauty effects and the quality and safety testing on the skin. The new regulations upgrade the home beauty device from "personal care appliances" to "medical devices", which not only delineates a new runway for it, but also is equivalent to putting the radio frequency beauty device with a high risk factor into the "cage" of supervision - through the strict medical "ID card" and the "entry threshold", the beauty instrument is "washed by big waves".

Announcement No. 30 requires the relevant registrants and manufacturers of radiofrequency therapy devices and radiofrequency skin therapy devices to comprehensively strengthen the quality management of the whole life cycle of products, ensure the safety and effectiveness of marketed products, and take the initiative to report the relevant situation to the provincial drug regulatory department where the imported products are located (where the imported products are located). Up to now, a total of 25 radiofrequency therapy devices and radiofrequency skin therapy products have obtained medical device registration certificates, which can meet the needs of medical cosmetology. The State Food and Drug Administration will strengthen the guidance related to registration and better guide relevant enterprises to carry out the work related to the registration of medical devices.

From April 1, radio frequency beauty devices will usher in strict supervision with a new identity

According to Announcement No. 30, the working principle of radiofrequency therapy devices and radiofrequency skin therapy devices is generally to act radiofrequency energy on human skin and subcutaneous tissues through therapeutic electrodes, so that human tissues and cells undergo pathological/physiological changes, and are used to treat skin laxity, reduce skin wrinkles, shrink pores, tighten and lift skin tissues, or treat acne and scars, or reduce fat (fat softening or decomposition).

For example, radiofrequency beauty products that are expected to be used to "lighten wrinkles (such as forehead lines, crow's feet, etc.), reduce fine lines, remove wrinkles around the eyes, improve sagging and sagging, lift apple muscles, lift facial contours, tighten contours, tighten skin, lift and shape, and shrink pores" should be managed as Class III medical devices. RF products that do not meet the definition of medical devices are not managed as medical devices. For example, RF products whose intended use does not involve the circumstances specified in Announcement 30 and are only used for "non-invasive skin penetration promotion of essence (not used for drugs and medical device penetration), promotion of essence absorption, skin surface cleansing, warm massage, physical massage, skin relaxation, exfoliation" or similar purposes do not meet the definition of medical devices, are not managed as medical devices, and do not need to obtain a medical device registration certificate.

From April 1, radio frequency beauty devices will usher in strict supervision with a new identity

For products that have been purchased before April 1 and have not obtained a medical device registration certificate, consumers can continue to use them. However, from April 1, the relevant users are not allowed to purchase and use radio frequency therapy devices and radio frequency skin therapy devices that have not obtained medical device registration certificates in accordance with the law. In addition, production and operation enterprises can continue to provide after-sales service to users or consumers in accordance with relevant contracts or service agreements, and products produced before April 1, 2024 can be used for complete machine replacement.

(Dazhong Daily, Dazhong News client reporter Wang Heying)

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