Align Technology has received regulatory approval from the Chinese State Food and Drug Administration (SFDA) to market and sell the Invisalign system as a Class II medical device for the treatment of malocclusion (misalignment of teeth).
Align has 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.
Align International vice president Richard Twomey said that this is a significant milestone and they are very excited about the opportunity and growth potential for Invisalign in China.
“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,” Twomey said.