A focused ultrasound stimulator, designed for cosmetic procedures, is the first aesthetic device to benefit from the Hainan policy to allow the use of unapproved but urgently-needed medical devices.
On January 5, 2020, Hainan Boao Super Hospital began the clinical use of The Ulthera System, an FDA-cleared, non-invasive procedure that lifts and tightens the skin on the neck, chin and brow, and improves lines and wrinkles. The first group of patients with slack skin received 90-minute lifting treatments on the face and chin at the Medical Beauty Center. The device, manufactured by Ulthera, Inc., has not been approved nationally, according to the NMPA device approval database.
Unapproved but urgently-needed medical devices can be used in Hainan province, the China State Council announced in April 2018. As of September 16, 271 medical devices went through the special pathway to be clinically used in Hainan, according to the State Council Information Office news briefing (Link in Chinese).
Cosmetic Devices in China
The “New Oxygen 2019 White Paper on Medical Aesthetics Industry” (link in Chinese) shows that the consumption of Chinese aesthetic treatment ranked first in the world last year, exceeding that of the United States and South Korea. Non-surgical facial rejuvenation projects such as thermal frequency tightening, photon skin rejuvenation, and thermal lifting have increased by 92.64%.
“Chinese beauty goers can now get safe and effective treatment for their skin lifting without going abroad,” says Zhang Xuejun, Director of Institute of Dermatology, Shanghai Fudan University and Professor of Dermatology Department, Boao Super Hospital. “Meanwhile, the clinical use of the Ulthera System helps Ulthera to collect Real-World Data (RWD) for market approval.”
Some cosmetic devices are classified as medical equipment for the first time, according to the First Batch of Medical Device Classification Results published in July 2019. Previously cataloged as Non-Medical Devices in 2014, ultrasonic skin treatment equipment, ultrasonic electrical stimulation devices, and electrotherapy ultrasound therapy devices are now designated as Class II Devices.
Conveniently located in the south tip of China, Hainan province, an island called the Hawaii of the East, is a popular tourist attraction for beachgoers, winter escapers and shoppers.
About 600,000 people report medical treatment abroad every year, spending over US $10 billion annually. To retain more of this medical revenue within China, the central government wants to use Hainan as a medical pilot zone, so the expanding middle and upper classes do not have to go oversea to get treatment.
Real-World Data in Hainan
Eight overseas manufacturers participated in the Hainan RWD program piloted since June 2019, including one represented by China Med Device, LLC. RWD offers an alternative to currently available clinical pathways such as clinical evaluation report and overseas clinical data. Hainan is the first province to pilot Real-World Data in China. For acceptance criteria and the usage of RWD in China, please click HERE.
As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China. NMPA issued the “Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)” on December 13, 2019.
The ability to start using devices in clinical settings prior to national NMPA approval is especially significant for manufacturers with high-priced devices, as RWD program participants can generate clinical data in the actual clinical environment with service fees, whereas traditional clinical trials need to be complimentary.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx, and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP, and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy, and distribution qualification.