Many devicemakers exporting to China will have to comply with new standards next year. China’s State Food and Drug Administration (SFDA) has released 96 new standards for devices, including 34 mandatory standards and 62 recommended ones. They will go into effect June 1, 2012. Some of the mandatory standards, labeled YY, replace outdated ones, according to Pacific Bridge Medical, a consulting firm for the Asian medical sector. The standards cover such areas as orthopedic transplant devices, dental root canal devices and sterile medical equipment packaging testing methods.
International Medical Device Regulatory Monitor