Watch the archived free webcast "How to Achieve Compliance with IEC 62304 for Medical Device Software Development." Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development.
Manufacturers who want to export medical products to China must seek the approval of the China Food and Drug Administration (CFDA). Here is an overview of the process and recent changes in China’s regulatory landscape.