Chindex Complains About Slow China Medical Device Approvals

| About: Chindex International, (CHDX)

Chindex International (NSDQ: CHDX) received SFDA approval for two medical devices: the daVinci S Surgical System and the AlexLaser. Although Chindex was pleased to receive the approvals, its announcement was full of complaints about the length of time required for the SFDA to process the applications.

The news release from Chindex contained words like “finally,” “many months,” “long-awaited” and “significant delays” as the company’s characterization of the process. Chindex stated it believes these delays are “unfortunately very common in the medical device approval process in China today.”

The daVinci S Surgical System is a robotic surgical assistance product that allows minimally invasive techniques to be used in more surgeries. Originally approved in the US in 2000, over 850 of the daVinci devices are in use worldwide, even though the price exceeds $1 million. The product is manufactured by Intuitive Surgical (NSDQ: ISRG). Chindex has installed four daVinci S systems in Hong Kong, and another machine has been in operation at the People’s Liberation Army General Hospital in Beijing as a reference and testing machine since January 2007. According to Chindex, the machine has been used to perform almost 100 robotic cardiac surgeries since its installation. Chindex will be the exclusive distributor of the machine in China and Hong Kong.

The AlexLaser, a Q-switched Alexandrite laser manufactured by Candela Corporation (NSDQ: CLZR) is used for tattoo and pigmentation removal. Chindex says that the market in China for this product is very large.

Chindex operates in China (including Hong Kong) through two divisions: medical device distribution and a chain of private primary care hospitals and ambulatory clinics called United Family Hospitals and Clinics.

Disclosure: none.