Jul 18, 2019

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.

UDI implementation timeframes

NMPA plans a 12-month timeframe for running the UDI pilot.:

  • By the end of July 2019, parameters of the program as well as participating entities will be identified;
  • From August to November 2019, verification of created and assigned UDI data will occur;
  • Between December 2019 and February 2020, regulators will verify standards for uploading, downloading and interface standards applicable to the UDI database;
  • From March 2020 to June 2020, inter-departmental connectivity and extended applications of UDI data will be verified;
  • In July 2020, regulators will make improvements to the UDI implementation plan as needed, and plan to begin enforcing UDI requirements.

Additional details on NMPA’s UDI pilot will be covered in future posts.

Learn more about Chinese medical device regulations at Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Chinese medical device clinical and testing assessments
  • Regulatory process chart: China NMPA registration requirements