CFDA Announces New and Updated Requirements for Medical Device Quality Management

In January, 2017 the China Food and Drug Administration (CFDA) released a new industry standards report on quality management for medical devices. The new and updated requirements are intended to emphasize the importance of adhering to CFDA regulations. The quality management system standard has been redefined to apply to medical device companies at all stages of the life cycle chain. Additionally, there are new, more intense requirements based on risk analysis and management, medical device supply chain and procurement, and post-market surveillance. The CFDA completely revised its Good Manufacturing Practices (GMP) requirements for medical devices in 2014. In the past, GMP inspections in Chinese medical device manufacturing facilities have revealed major quality issues, including data falsification, defective manufacturing, and non-compliance with regulations.