Avita Medical Ltd has secured regulatory approval for its ReCell Autologous Spray-On Skin from the Chinese State Food and Drug Administration (SFDA). ReCell has been issued an unrestricted import license. The SFDA is responsible for regulation and supervision of medical products and is the competent authority for drug regulation in mainland China.
Dr William Dolphin, CEO of Avita Medical, said, “China is a key market for the company’s products. ReCell addresses the growing demand for cosmetic surgery, scar revision and burns treatment. The product is being targeted to China’s burgeoning middle class, a rapidly growing segment of the country’s 1.3 billion people.”
“Helicon has done an excellent job of shepherding the ReCell application through the highly complex SFDA approval and registration process,” said Dr Dolphin. Avita Medical anticipates training Helicon representatives and meeting with key surgeons and influencers in the next few months. The company has held meetings with key surgeons in China including highly placed surgeons in military hospitals. During the early stages of market development Avita and Helicon will participate in conferences and workshops to maximise acceptance and uptake of the ReCell product.