The State Food and Drug Administration regulates the chaos in the medical beauty market to clear the "edge ball" water light needle

　　The State Food and Drug Administration regulates the chaos in the medical aesthetics market and clarifies that water-light acupuncture is managed as a Class III medical device

　　Can the new regulations clear the "edge ball" water light needle

　　In the future, if there is a medical beauty agency that sells a product that is not a Class III medical device as a "water light needle", then the agency can directly block it.

A reporter from Beijing Youth Daily learned that the State Food and Drug Administration issued an announcement on "adjusting some of the contents of the "Medical Device Classification Catalog", and "Shuiguang Needle" is clearly regulated in accordance with Class III medical devices.

　　investigation

　　Water light needle micro-rectification fire

　　The market is "mixed"

　　"One injection of water light is equivalent to applying 1,000 masks" "Aunt becomes a girl, with only a mixed water light injection in the middle" "One injection can solve N kinds of moisturizing, shrinking pores, diluting fine lines, whitening and removing freckles, etc. Question" "Lunch beauty, minimally invasive without knife"...

　　The moisturizing and skin care effect of Shuiguang Acupuncture has been popularized by various Internet celebrities, and it has become a hot-selling item in the non-surgical "light medical beauty" market, attracting thousands of women to be obsessed with it.

The injection operation of Shuiguang Needle is very convenient, and the whole process only takes 1-2 hours. It seems to be an "efficient and safe" entry-level medical aesthetic project.

On Xiaohongshu, there are more than 100,000 herbal notes related to "Shuiguang Needle" and "Shuiguang Needle Medical Beauty".

　　At present, the price of a dose of water light needles on the market ranges from several hundred to several thousand, or even tens of thousands of yuan.

Tianfeng Securities pointed out that from the perspective of classification, the scale of non-surgical medical aesthetics in my country is rapidly expanding, and the proportion remains at about 70%, which is higher than the global average.

　　Such a huge market, but very chaotic.

According to the "2020 China Medical Beauty Industry Insights White Paper" data, the current injection rate in the medical beauty market is only 33.3%, that is, out of every three injections, two are illegal injections such as parallel imports and fakes.

　　chaos

　　Medical dressings and cosmetics are on the scene

　　"Shuiguang needle" market chaos

　　A reporter from Beiqing Daily inquired about some medical beauty platforms and found that the types of Shuiguang injection used on the platform are far more than the "sodium hyaluronate for injection" that has been approved as a "class III medical device". .

Not only that, the Beiqing Daily reporter noticed that some products with the status of "Class III medical devices" have their approved indications but are irrelevant.

　　For example, a water light needle named "Zhuweike", whose product name is "Medical Sodium Hyaluronate Gel", has also obtained the level of "Class III medical device", but its registration scope is "auxiliary use". For the prevention and reduction of postoperative adhesions in abdominal (pelvic) surgery".

　　The "true identity" of more water-light needles is actually medical dressings, the kind that cannot be used for injections, and some even only have the record number of cosmetics.

　　A reporter from Beiqing Daily noticed that a human-like collagen bio-repair dressing called "Kelijin" is a Class II medical device and has been approved as a product for healing damaged wounds, but it is used as a water light needle in some medical and beauty institutions. injection.

The product of "Evolution" water light collagen is called yeast recombinant collagen liquid dressing, and it is also a class II medical device, which has been approved for "adjuvant treatment of skin diseases caused by damaged skin barrier function, improvement of dermatitis, eczema, etc. pruritus", etc., and is not approved for injection.

In September 2020, it was reported that a Yueyang woman was disfigured by acupuncture, and the agency injected her with "Feymand Youth Essence Enhanced" and "L-VC".

Among them, "Fiemande" belongs to cosmetics, while "Levo-VC" does not have any Chinese logo on the box.

　　Not only that, but on some e-commerce platforms, there are hundreds of cosmetic products with the identity of "water light needle" that are actually essences, creams, and masks.

However, as a medical beauty project, the three words "water light needle" cannot pass the cosmetic filing.

According to industry insiders, calling cosmetics "water light needles" is nothing more than a gimmick made by businesses to increase sales.

　　Supervision

　　Clarify the identity of "water light needle"

　　Clear "Edgeball" behavior

　　A few days ago, the State Food and Drug Administration issued a notice on "adjustment of some contents of the "Medical Device Classification Catalog", and the 27 categories of medical device classification catalogs have been readjusted.

Among them, in particular, major adjustments have been made to the catalogue of some medical and cosmetic products.

The "Catalogue" clarifies that the sodium hyaluronate solution for injection, which is the main component of "Shuiguang Needle", is used for injection into the dermis, and it mainly improves the skin condition through the moisturizing and hydrating functions of the contained sodium hyaluronate and other materials. In accordance with the supervision of Class III medical devices.

　　Previously, on November 9, 2021, the Medical Device Standards Management Center of the State Drug Administration issued a notice on soliciting opinions on the adjustment of the "Medical Device Classification Catalog", which further clarified that the water light needle is classified as a Class III device for supervision.

　　Analysts believe that the adjustment of some contents of the "Medical Device Classification Catalog" will have a significant impact on the medical beauty industry.

The most obvious is to strictly control the use of non-compliant products by institutions.

And through the classification of medical devices, the "edge ball" behavior in the market is gradually eliminated.

　　According to the "Regulations on the Supervision and Administration of Medical Devices", enterprises engaged in the operation of Class III medical devices are subject to business license management. The requirements for bacteria preservation will also be much higher than those of Class I and Class II medical devices.

　　This group of articles / reporter Zhang Xin

　　Key words

　　water light needle

　　The so-called water light acupuncture uses a negative pressure needle to inject hyaluronic acid (hyaluronic acid), collagen and other substances into the dermis of the skin to make the skin firm and elastic.

According to the Medical Device Technology Review Center of the State Food and Drug Administration, water light acupuncture is a therapy that injects a solution with sodium hyaluronate as the main component into the superficial dermis of the face to improve the skin condition.

As a skin-breaking injection project, water-light acupuncture products should first pass the Class III medical device certification of the State Drug Administration before they can be produced and sold.

　　However, it takes a long time to apply for a Class III business license for medical devices and requires a lot of experiments, and requires the production company to have a quality management organization or full-time quality management personnel that is suitable for the business scale and business scope, which makes many businesses opportunistic.