China – Chinese regulators preparing medical device UDI pilot

The National Medical Products Administration (NMPA), China’s medical device market regulator, has begun laying the groundwork for a Unique Device Identification (UDI) pilot program scheduled to run through July 2020.

NMPA will carry out the pilot (link in Chinese) in collaboration with the National Health Care Security Administration (NHCSA) as well as the National Institutes of Medical Device Standards Management. The pilot will prioritize higher-risk devices including cardiac and craniocerebral implants and prostheses, but all device types will eventually be involved, according to Emergo by UL consultants in Beijing.

Roles and responsibilities of UDI pilot participants

NMPA has identified three groups of pilot participants, and assigned responsibilities to each group:

  • Medical device manufacturers will create UDI numbers according to UDI system rules and standards, assign UDIs to their products, and upload UDI information to a UDI database (link in Chinese) under development. Manufacturers will also develop UDI application methods to support device traceability as well as appropriate operational specifications.
  • Distributors will set up workflows for application of UDI to commercial operations, verify parallel operations for multiple codes, and determine docking operation processes for UDI data and business systems.
  • Users will manage docking of UDI data to medical business systems, as well as develop and examine connections between UDI, medical device and clinical applications…