New China QMS Regulations to be Released This Year

A quality management system (QMS) long has been an element in Chinese medical device manufacturing. In fact, the official industry standard for quality management, which was released in 2003, is titled “Medical Devices: Quality Management Systems—Requirements for Regulatory Purposes” (YY/T 0287-2003). This standard followed many of the requirements from ISO 13485:2003. Despite the good intentions of the standard, however, the implementation and supervision of the directive was grossly lacking. Financial greed and desire for quick growth drove many companies to ignore basic quality controls of their operations and products. What resulted from such neglect were numerous high-profile adverse events in China in the drug and medical device markets in 2006 and 2007, which prompted the government to “clean house” at the SFDA and remove key officials.

The positive result of the SFDA shake-up was that QMS finally gained the spotlight that it deserves. The increased recognition also is aided by drafts of new QMS regulations. In 2006, SFDA released a set of newly drafted guidelines on quality management, including the “Code for Quality Management System of Medical Device Manufacturers,” which is in trial phase. Besides the general guidelines for all medical device companies, SFDA also drafted two additional QMS regulations specifically designed for sterile and implantable product manufacturers. In the same year, SFDA launched a trial implementation of these QMS regulations by selecting 51 of 110 implantable and sterile product manufacturers to implement and verify their quality system management procedures. The trial program was completed in late 2006. More revisions of the regulations were made in 2007 and 2008. These new QMS regulations are expected to be released officially this year.