National Medical Products Administration standardizes the chaos in the medical and beauty market, and clarifies the management of water needles according to Class III medical devices.
In the future, if a medical and beauty institution comes up with a product that is not a class III medical device and sells it to you as a "water needle", then this institution can directly pull the black. The Beijing Youth Daily reporter learned that National Medical Products Administration issued a notice on adjusting some contents of the Classification Catalogue of Medical Devices, and "Shuiguangzhen" was clearly regulated according to Class III medical devices.
survey
Water-light needle slightly corrects the fire.
The market is "mixed"
"Playing a water-light needle is equivalent to applying 1000 masks", "Aunt turns into a girl, only separated by a mixed water-light injection", "One needle can solve N kinds of problems such as hydrating and moisturizing, shrinking pores, lightening fine lines, whitening and removing spots" and "lunch beauty, minimally invasive without moving the knife" … …
The hydrating and skin care effect of Shuiguangzhen has been aroused by various road networks, and it has become a hot item in the non-surgical "Light medical cosmetology" 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 beauty project. In Little Red Book, there are as many as 100,000 notes on planting grass related to "Shuiguangzhen" and "Shuiguangzhen Medical Beauty".
At present, the price of a dose of water-light needle ranges from hundreds to thousands, or even tens of thousands of yuan. TF Securities pointed out that from the classification point of view, the scale of non-surgical medical beauty in China has expanded rapidly, while the proportion has remained at around 70%, which is higher than the global average. It is estimated that the scale of young medical beauty industry will exceed 200 billion yuan in 2023.
Such a huge market is very chaotic. According to the data of "White Paper on Insights into Medical Beauty Industry in China in 2020", at present, the genuine rate of injections circulating 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 one after another.
"Shuiguangzhen" market is chaotic
When the reporter of Beiqing Daily inquired about some medical beauty platforms, it was found that the types of water-light needles used on the platforms were far more than the "sodium hyaluronate for injection" that had been approved as "Class III medical devices". Not only that, the reporter of Beiqing Daily noticed that some products with the status of "Class III medical devices" have been approved for indications that are irrelevant.
For example, a water-light needle named "Shu Wei Ke", the product name is "Medical Sodium Hyaluronate Gel", and it has also obtained the level of "Class III Medical Device", but its registered application scope is "Auxiliary for preventing and reducing postoperative adhesion of abdominal (pelvic) cavity surgery".
The "true identity" of more water needles is actually a medical dressing, which can’t be used for injection, and some even only have the record number of cosmetics.
The reporter of Beiqing Daily noticed that a kind of human collagen bio-repair dressing named "Kelijin" is a Class II medical device, and it has been approved as a product for healing damaged wounds, but it has been used as a water needle injection in some medical and aesthetic institutions. The product of "Yifuquan" water-light collagen is called yeast recombinant collagen liquid dressing, which is also a class II medical device. It has been approved for "adjuvant treatment of skin diseases caused by impaired skin barrier function and improvement of skin itching caused by dermatitis and eczema", etc., and has not been approved for injection. In September, 2020, it was reported that a Yueyang woman was disfigured when she was given a water-light needle, and the organization injected her with "Femander Youth Essence Enhanced" and "levorotatory VC". Among them, "Feimande" belongs to cosmetics, while the box of "levorotatory VC" does not have any Chinese logo.
Not only that, on some e-commerce platforms, there are hundreds of cosmetics that are actually essence, cream and mask with the identity of "water needle". However, as a medical beauty project, the word "Shuiguangzhen" cannot be put on record through cosmetics. According to insiders, calling cosmetics "water needle" is nothing more than a gimmick made by merchants to improve sales.
Supervision
Clarify the identity of "Shuiguangzhen"
Clear the "edge ball" behavior
A few days ago, National Medical Products Administration issued an announcement on adjusting some contents of the Classification Catalogue of Medical Devices, which readjusted the classification catalogue of 27 types of medical devices. Among them, especially the catalogue of some medical beauty products has been greatly adjusted. According to the Catalogue, sodium hyaluronate solution for injection, which is the main component of "water-light needle", is used to inject into the dermis, and the skin condition is improved mainly through the moisturizing and hydrating effects of materials such as sodium hyaluronate, and it is regulated according to Class III medical devices.
Previously, on November 9, 2021, National Medical Products Administration Medical Device Standard Management Center issued a notice on soliciting opinions on the adjustment of the Classification Catalogue of Medical Devices, which further clarified that Shuiguang needles were classified as Class III devices for supervision.
Analysts believe that the adjustment of some contents of the Catalogue of Medical Devices will have a significant impact on the medical and beauty industry. The most obvious is to strictly control the use of non-compliant products by institutions. 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, and business units need to hold a Medical Device Operation Record Certificate or a Medical Device Operation License, and the requirements for production technology and aseptic preservation will be much higher than those for Class I and Class II medical devices.
This group/reporter zhangxin
Photo courtesy/vision china Coordinator/Yu Meiying
keyword
Shuiguangzhen
The so-called water-light needle is to inject hyaluronic acid (hyaluronic acid), collagen and other substances into the dermis of the skin by using negative pressure needle to make the skin firm and elastic. National Medical Products Administration Medical Device Technology Evaluation Center once said that water-light acupuncture is a kind of therapy that injects sodium hyaluronate as the main component into the superficial layer of facial dermis to improve the skin condition. As a skin-breaking injection project, water-light needles should be certified as Class III medical devices in National Medical Products Administration before they can be produced and sold.
However, it takes a long time to apply for Class III business license of medical devices and a lot of experiments are needed, and the production company is required to have a quality management organization or full-time quality management personnel suitable for the scale and scope of business, which makes many businesses opportunistic.