Tighter MedicalDevice Regulations On Dec. 27 last year, China’s State Food and Drug Adminis

Tighter MedicalDevice Regulations

On Dec. 27 last year, China’s State Food and Drug Administration announced 96 new industry standards concerning medical devices in China. Thirty-four of these new industry standards are mandatory, while the remaining 62 are recommended. The mandatory standards will be regulated beginning June 1, 2012. The recommended industry standards cover sterile medical equipment packaging testing methods, dental root canal devices and orthopedic transplant devices, among others.

With the increased focus on the quality and availability of urban and rural healthcare, there also is strong growth potential for high-end, advanced medical devices. This segment is dominated by foreign medical device companies. Demand also should increase for medical devices that detect or combat chronic diseases associated with changing lifestyle habits.

With increasing healthcare awareness in China, the country’s total healthcare market is expected to triple from the current estimate of more than $200 billion to more than $600 billion by 2020.