Food and Drug Administration: "Shuiguang Needle" is planned to be supervised by Class III medical devices

On November 9, the Medical Device Standards Management Center of the State Drug Administration issued a notice on the solicitation of the "Medical Device Classification Catalogue" (adjustment opinions)
.

It is reported that the adjustment opinions are based on the "Dynamic Adjustment Work Procedures for Medical Device Classification Catalogue" and related requirements.
The Medical Device Standards Management Center of the State Drug Administration organized the medical device classification technical committee to study and form it .
Regarding the adjustment of the regulatory category of some medical beauty products, the notice shows that the sodium hyaluronate solution for injection is composed of a syringe and a filling material pre-installed in the syringe (usually sodium hyaluronate as the main component), and the product is used for injection To the dermis of the face, the skin condition is improved mainly through the moisturizing and hydrating effects of materials such as sodium hyaluronate, and it is planned to be supervised in accordance with Class III devices .
The sub-category is 13-passive implant devices, 09-plastic and general surgical implants, and the secondary product category is 02 plastic injection fillers .

Sodium hyaluronate has strong hydrophilicity, and the medical beauty industry often uses it to "lock water".
For example, a solution with sodium hyaluronate as the main component is injected into the superficial dermis of the face to improve the skin condition-"water light needle" "

According to the "Questions and Answers for Medical Aesthetics Related Products" previously released by the Medical Device Standards Management Center of the National Medical Products Administration, currently approved filler products with sodium hyaluronate as the main ingredient in my country are mainly:

1) Based on cross-linked sodium hyaluronate: "cross-linked sodium hyaluronate gel for injection", "modified sodium hyaluronate gel for injection";

2) With non-crosslinked sodium hyaluronate as the main component: "sodium hyaluronate composite solution for injection";

3) And those containing sodium hyaluronate: "Medical hydroxypropyl methyl cellulose-sodium hyaluronate solution", "Medical sodium hyaluronate-hydroxypropyl methyl cellulose gel", "Medical containing polyethylene sodium hyaluronate gel microspheres alcohol - hydroxypropylmethylcellulose hydrogel "," containing L-lactic acid - glycol copolymer microspheres of crosslinked sodium hyaluronate gel "and the like

The scope of application approved for the above products is mostly used to correct moderate to severe nasolabial folds, a few are used to correct forehead wrinkles, and a very few are used for lip augmentation, rhinoplasty, mid-face injection and filling, and correction of neck or hand wrinkles

At the same time, the answer to the question emphasized that, as of now, there is no legal "water light needle" implant that has been approved for listing under the supervision of medical devices

In addition, this adjustment opinion also adjusted the supervision of other parts of the medical aesthetics product category, including:

Radio frequency treatment equipment, radio frequency skin treatment equipment, if the product uses radio frequency energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.
), it will cause pathological/physiological changes in human tissues and cells to tighten loose skin and reduce skin Wrinkles and folds, improvement of skin appearance, etc.
, are planned to be supervised in accordance with Class III devices
.
The sub-category is 09-Physiotherapy Equipment, the first-level product category is 07-High-frequency treatment equipment, and the second-level product category is 01-RF hyperthermia equipment;

High-frequency electric field skin heat therapy equipment, radio frequency therapy equipment, if the products are used for non-traumatic superficial treatment of face, body, neck, etc.
, it is planned to be supervised in accordance with Class II devices
.
The sub-category is 09-Physiotherapy Equipment, the first-level product category is 07-High-frequency treatment equipment, and the second-level product category is 02 Radio-frequency superficial treatment equipment;

An example of the product name of the newly-added facial implant thread is planned to be supervised in accordance with Class III devices
.
The sub-category is 13-passive implant devices, 09-plastic and general surgical implants, and the secondary product category is 01-plastic filling materials