New Industry Standards for Medical Devices in China

On December 27, 2010, China’s State Food and Drug Administration (SFDA) website was updated with an announcement on 96 new industry standards that will affect medical devices in China. 34 of these new industry standards are mandatory (labeled YY) while the remaining 62 are recommended (labeled YY/T). The mandatory standards will be regulated beginning June 1, 2012.

Several of the mandatory industry standards are replacing other standards. For example, YY 0054-2010 for hemodialysis equipment will be replacing YY 0054-2003, and YY 0333-2010covering soft tissue dilation devices will replace YY 0333-2002. However, many others are new, such as YY 0804-2010 for medical fluid metastatis.

The recommended industry standards cover sterile medical equipment packaging testing methods, dental root canal devices, orthopedic transplant devices, and more.

For the full list of new industry standards in China, please visit (Chinese only).