The Chinese State Food and Drug Administration (SFDA) recently updated its website with 96 new industry standards affecting medical devices. Thirty-four of them are Mandatory Standards (labeled YY), whilst the remaining 62 are Recommended Standards (labeled YY/T). All will take effect on 1 June 2012. These are the first group of new standards since China began modifying regulations for its medical device industry in 2010.
In addition to many new standards, some of the mandatory standards are replacing obsolete ones. For example, YY 0054-2010 for haemodialysis equipment will replace YY 0054-2003, and YY 0333-2010 covering soft tissue dilation devices will replace YY 0333-2002.
Although the standards cover a range of devices and equipment, blood glucose meters are not listed, which triggered some disputes last year.
The new standards have been well received by medical device companies, and will help make Chinese device manufacturers more competitive with their international counterparts. However, chronic delays in updating standards remain a concern. Although it is improving, this has been a slow process historically. Delays in updating hinder innovation among domestic manufacturers and increase the potential for adverse events.
The full list of standards are listed on the SFDA website in Chinese. Global medtech consultancy Medtech Review LLC has made available the English translation of SFDA’s list of 34 new mandatory regulations on its website.
— Helen Zhang, Associate Editor, Chinese Medical Device Manufacturer