China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their] Good Manufacturing Practice for Medical Devices compris[ing] [of] 84 articles in 13 chapters, which requires medical device manufacturers to set up and improve the quality management system in accordance with this GMP, and specifies relevant requirements on organization and personnel, premises and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales services, control of nonconforming products, adverse event monitoring, analysis and improvement etc.”

Why BBA

http://eng.sfda.gov.cn/WS03/CL0770/98157.html

China has a new medical device classification catalog: what you need to know