China CFDA Medical Device Registration Requirements

Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug Administration (CFDA). The CFDA has strict regulatory requirements, especially for foreign manufacturers who want to import their products to China. It's important to understand the requirements before you begin the registration process.

In this white paper, we'll answer your biggest questions about what it takes to start selling your medical device in China. You will learn:

  • steps in the registration process
  • an overview of the regulatory structure
  • how to classify your device
  • an overview of in-country testing and clinical requirements
  • what to do if your device is "novel" in China

You'll learn all this and more in this 8-page white paper.