Medical Aesthetics – Welcome to the Chinese Market

Regulatory Upgrades in China: The Medical Aesthetics Industry Enters an Era of Compliant Development in 2022

Cracking down on chaos in the medical aesthetics industry

In 2020 and 2021, Chinese authorities, including the National Health Commission and other departments, initiated stringent measures to regulate the medical aesthetics industry. MORE

Standardizing industrial standards

In 2022, China’s National Medical Products Administration introduced several draft revisions to tighten regulations on medical devices, focusing on managing non-compliant products like hyaluronic acid needles, radiofrequency instruments, and thread embedding under stricter supervision. MORE

Raising the threshold for surgeries

In efforts to regulate the medical aesthetics industry in China, significant measures were implemented from 2020 to 2022. MORE

Strictly regulating marketing channels

China has taken significant steps to regulate the medical aesthetics advertising industry from 2021 to 2022. New guidelines were introduced to target misleading advertisements, prevent the exploitation of patients’ images and names, and control the portrayal of ‘doctors’ and ‘experts’ in such ads. MORE

Medical Aesthetic Products in the Chinese Market

Photonic Medical Aesthetic Products

Ultrasonic Aesthetic
No NMPA Approved Class III Ultrasonic Aesthetic Products in the Chinese Market

RadioFrequency
China’s Regulatory Change will Resuffle the Market in China for RF Products

Intensed Pulsed Light (IPL)
Huge Demands in China, Distinc Price Advantage of Domestic Chinese Brands

Laser Technology
Rising Popularity in Hair Removal

Hyluronic Acid
Hyaluronic acid fillers are one of the most popular injectable aesthetic treatments in China.

Botulinum Toxin
In Mainland China, the state’s regulatory bodies maintain stringent control over botulinum toxin products, setting high barriers for market entry.

Regenerative Materials
Regenerative filler products are classified as collagen stimulants, which, when injected into subcutaneous tissues, stimulate the body’s own fibroblasts and collagen response.

Active Materials
Active materials are based on non-crosslinked sodium hyaluronate, compounded with a variety of nutrients.

Medical Aesthetic Products’ Instant Market Access to China – Hainan Boao Lecheng Medical Tourism Pilot Zone

“Exclusive to China, the Hainan Boao Lecheng Medical Tourism Pilot Zone (the Pilot Zone) offers a unique Urgent Use Program, allowing international medical device manufacturers to trial China-not-yet-approved innovative devices on Chinese patients. Here, manufacturers can collect clinical evidence, generate sales revenues, showcase advancements, and benefit from Hainan’s commercial and regulatory advantages.”

Commercial & Regultory Benefits of the Hainan Pathway

Commerical Benefits

Building relationships with Chinese medical institutions, practitioners, and stakeholders
Increaded brand visibility
Real-World feedback to improve device and training
Potential tax or economic incentives
Gateway to broader Chinese market

Regulatory Benefits

Accelerated market entry
Pre-Sub consultation
Real-world study
Clinical data on Chinese population

Examples of Medical Aesthetic Products Landing to the Hainan Boao Lecheng Medical Tourism Pilot Zone via the Urgent Use Program

Micro-Focused Ultrasound Treatment Instrument
Lidocaine-Containing Cross-linked Hyaluronic Acid Sodium Gel for Injection
MemoryGel Xtra Artificial Breast Implant
Legend Pro+ Radiofrequency Treatment Instrument
PiQo4 Laser Treatment Instrument
HAIRCARE
Injectable Facial Repair Material (CYTOCARE)

AestheFill Tissue Repair Material (AestheFill)
Deneb Sterile Absorbable Hyaluronic Acid Subcutaneous Filler
Injectable Sodium Hyaluronate Composite Solution
Injectable Sodium Hyaluronate Solution
Injectable Cross-linked Sodium Hyaluronate Gel
Lidocaine-Containing Cross-linked Sodium Hyaluronate Gel for Injection
Poly-L-Lactic Acid Collagen Stimulator

Medical Aesthetics — Welcome to the Chinese Market