Align Technology has received regulatory approval from the Chinese State Food and Drug Administration to market and sell the Invisalign system as a class II medical device for the treatment of malocclusion, the company announced.
Align also received its License of Medical Device Operation Enterprise (Enterprise License) from the Shanghai Food and Drug Administration, which allows the company to distribute Invisalign in China. Align expects to begin commercial availability of Invisalign in the second half of 2011.
"This is a significant milestone and we are very excited about the opportunity and growth potential for Invisalign in China," said Richard Twomey, Align vice president of international, in a press release. "With rising income levels, increased spending on discretionary items such as high-end luxury goods, and heightened focus on health and aesthetics, China is poised to be one of the fastest-growing markets for orthodontics in the foreseeable future."
Over the past decade, the Chinese orthodontic market has grown steadily as the importance of dental health and personal appearance has increased among the general population of 1.4 billion, Align noted. Today, China is estimated to have nearly half a million new orthodontic case starts each year, with a higher percentage of complex class II and III malocclusion cases than in Western countries. Most orthodontic treatment is done within government-owned hospitals in major metropolitan cities; however, rising consumer demand has led to accelerated growth of private dental clinics, according to Align.
"With over 1.3 million patients treated worldwide, Invisalign is a cutting-edge treatment technology that has been used by many doctors to treat a very broad range of malocclusion," said Yanheng Zhou, chair of the orthodontics department at Peking University School of Stomatology. "The time is right for Invisalign in mainland China."
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