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FAQ on Aesthetic Medicines | China CMDE

The aesthetic medicine market in China is booming with the market size growing from 64.8 billion yuan in 2015 to 176.9 billion yuan (about $27.47 billion) in 2019.1

Though the growth has been slowing down since 2018 due to oversupply and the ongoing COVID-19 pandemic, the market is predicted to recover and reach 311.5 billion yuan (about $48.25 billion) in revenue by 2023.

Facing such a niche, a swarm of aesthetic medical products rushed into the market. Some products, unqualified or improperly used, even caused medical accidents.

China's Regulatory Measures on Aesthetic Medicine

China authorities decided to crack down on illegal medical aesthetic services with a special work plan2 released in June, 2021. The plan stipulated that aesthetic medical business shall not use unqualified medicines, medical devices or disinfectant devices.

The National Medical Products Administration (NMPA) announced this September that it would enhance the regulation on injectable fillers for cosmetic surgery and light therapy devices for aesthetic practice.

NMPA also reminds that aesthetic medicine suppliers and therapy centers should purchase authorized medical devices legally, and keep the records of purchases and sales.3

NMPA's affiliated office Center for Medical Device Evaluation (CMDE) recently released FAQ about three hot aesthetic medical products—Thermage, hyaluronic acid and collagen.4 The FAQ specified the products' definitions, functions and how they are regulated by authorities, as an effort to help consumers understand more about aesthetic medicine.

1. Thermage

Thermage was initially the name of medical device company Thermage, Inc. and its product Thermage CPT System. After the product was introduced to China, Thermage spread wider and was even used to refer to radiofrequency (RF) devices in aesthetic practices.

Three types of RF devices vary in mechanisms for skin rejuvenation.

Three Types of Radiofrequency Devices for Aesthetic Practice in China

Type 1:

The RF devices harness certain-frequency electronic currents that can create heat through human tissues. Stimulated by heat, the skin can produce collagen, thus contributing to fewer skin wrinkles.

The temperature is controlled within an appropriate range through lowering current density with the expanded contact areas between the electrodes and the skin.

Type 2:

The RF devices use electrodes (usually microelectrode arrays) with smaller contact areas to create higher current density. The currents cause damage and peeling to stimulate the skin to rejuvenate with less wrinkles, acne and scars.

Type 3:

Besides the electrode arrays, the RF devices also use radiofrequency micro-needling. Through needling, the devices can transmit energy to deeper dermal layers to achieve better therapeutic effects.

Common cosmetic RF devices use bipolar or multipolar radiofrequency to transmit energy closer to the epidermis and superficial area adjacent to the epidermis.

If the devices use monopolar radiofrequency or add extra modulated pulses, the RF energy would possibly reach the deeper adipose tissue so that fat could be reduced. There were such devices applying for marketing authorization but were denied by NMPA.

Currently, the cosmetic RF devices with marketing authorization in China are only approved to treat skin wrinkles and atrophic scars.

2. Hyaluronic Acid

Hyaluronic acid (HA) usually exists as sodium hyaluronate, a kind of sodium salt. HA is distributed widely in human body parts such as joints and cartilages.

2.1 Classification of hyaluronic acid for medical use

Classification of Hyaluronic Acid for Medical Use in China

1. Register as drug products

Hyaluronic acid products with confirmed pharmacological effects, such as therapeutic effect on arthritis, xerophthalmia, skin ulcer, etc.

2. Register as Class III medical devices

Hyaluronic acid products for filling and increasing tissue volumes.

3. Register as medical devices, with classes depending on specific functions

Hyaluronic acid products that are adjuvants to ophthalmic surgeries, surgical anti-adhesion products, etc.

4. Others

Depending on the hyaluronic acid product's specific ingredients and mechanism of action.

Source: NMPA's Announcement on the Classification of Hyaluronic Acid Products5 and the Medical Device Classification Catalog in China6

2.2 Approved hyaluronic acid products

Hyaluronic acid product in China

Function

Approval

Ÿ    Cross-linked sodium hyaluronate as the main ingredient

 

Mostly with "Cross-linked Sodium Hyaluronate Gel for Injection" or "Modified Sodium Hyaluronate Gel for Injection" as a keyword in the product name.

Smooth wrinkles and fine lines.

Some products in the category are approved

Ÿ  Uncross-linked sodium hyaluronate as the main ingredient

Including the approved Sodium Hyaluronate Compound Solution for Injection (Registrant: IMEIK Technology Development Co., Ltd.)

Ÿ  Dermal filler products containing sodium hyaluronate as a complementary ingredient

Some products in the category are approved

Ÿ  Solution for injection using sodium hyaluronate as the main ingredient, which is only injected to the superficial layer of the dermis.

*Sodium hyaluronate has water-binding properties so surgeons use it to retain moisture in the skin.

Moisturizing facial skin.

None products in the category are approved

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3. Collagen

Collagen is the main structural protein in human tissues and organs. As a significant component of human bodies, collagen accounts for 30% to 40% of the whole-body protein content.

3.1 Manufacturing of collagen

Collagen products are mainly made from animal tissues or tissues (skin, placenta, etc.) from humans.

Recombinant collagen refers to collagen manufactured with recombinant DNA technology. Recombinant collagen's amino acid sequence can be designed and improved according to specific needs.

3.2 Approved collagen products

In aesthetic medicine, collagen is used as a filler injected into the face. It can render the skin plump and smooth, thus softening and removing the wrinkles.

Approved Collagen Products in China

Type

Name

Function

Collagen filler

Including "Collagen Implant", "Collagen Implant with Lidocaine", "Collagen Filler for Medical Use", "Type III Recombinant Freeze-dried Human Collagen Fiber", etc., as a keyword in the product name.

E.g., smoothing nasolabial folds or dynamic wrinkles on the forehead.

Dressing

Including "Collagen Dressing", etc., as a keyword in the product name.  

E.g., healing aid for laser wounds after surgery.

For any needs of registering aesthetic medicine products in China, send an email to contact@chemlinked.com. We would be glad to offer guidance.

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