Aug 28, 2019

The National Medical Products Administration (NMPA), China’s medical device market regulator, has published official Unique Device Identification (UDI) requirements that will take effect October 1, 2019.

According to NMPA as well as Emergo by UL consultants in Beijing, the new rules lay out UDI responsibilities both for manufacturers as well as code agencies that will issue UDI labels for devices. UDIs in China will include product identification unique to particular devices as well as production identification data such as serial and batch numbers, production dates and manufacturing process information.

NMPA’s UDI implementation roadmap

Manufacturers that are either applying for Chinese market access or submitting modifications to their existing NMPA registrations must take the following steps:

  • Select a Chinese company as their code agency;
  • Create a product UDI based on code agency standards;
  • Submit UDI data into NMPA’s eRPS system for electronic registration management;
  • Select appropriate data carrier according to code agency standards;
  • Upload UDI and related data into the Chinese UDI database before commercializing a device;
  • Promptly update UDI data in the UDI database when product UDI or related information changes.

NMPA has also set the following rules for companies to qualify as code agencies under the new UDI system:

  • Qualifying companies must be based in China, maintain adequate quality management and operation systems, and meet Chinese data security requirements;
  • Agencies must provide their standards implementation processes to registrants and guide manufacturers’ implementation efforts;
  • Agencies must upload their coding standards to China’s UDI database and maintain that data;
  • Annual reports from code agencies should be submitted to NMPA by January 31 of each year.

Although NMPA does not specify rules for code agency UDI standards, the regulator suggests that agencies develop such standards based on International Medical Device Regulators Forum (IMDRF) and other international recommendations.

UDI implementation rules more specific to each NMPA medical device classification will be issued in the future, according to the agency. 

The new rules follow reports that NMPA is launching a UDI pilot program in coordination with other Chinese government agencies that will initially target high-risk devices.

Learn more about China NMPA medical device regulatory issues at Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Process chart: NMPA regulatory approval for medical devices
  • Whitepaper: China NMPA medical device registration