Medical device registration requirements in China

China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s medical device regulator, National Medical Products Administration (NMPA), indicates that medical device approvals decreased by 38% in 2018 compared to 2017, possibly as a result of the depth and breadth of medical device regulatory changes underway in China. Manufacturers who are considering accessing this market will benefit from understanding the ever-changing regulatory landscape in the country.

In this free webinar, market experts Janet Zhang and Annika Chen will discuss key medical device registration requirements in China, including:

  • The history and regulatory structure of the NMPA, formerly known as the China Food and Drug Administration (CFDA)
  • The regulatory pathway for market access
  • Recent initiatives to ease regulatory requirements for foreign manufacturers of medical devices
  • Details on implementation of the NMPA’s new electronic medical device registration management (eRPS) system
  • New Unique Device Identifier (UDI) requirements
  • And more

Dec 12, 2019