The Rules for Unique Identification System for Medical Devices (hereinafter referred to as the Rules), released in August 2019 by China National Medical Products Administration (NMPA), has ushered in the stepwise implementation of Unique Identification system for medical devices.

GS1 China is a qualified issuing agency for UDI in China and GS1 standards meet the NMPA’s criteria for issuing UDIs. GS1 Member Organisations across the world will help manufacturers implement with the requirements of the NMPA UDI regulation, to support patient safety and supply chain security.

On October 14, 2019, NMPA issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices (hereinafter referred to as the Announcement), which clearly defines the scope, schedule and work requirements of unique identification for the first batch of medical devices. As per the Announcement, for medical devices listed in the first batch, the registrant shall follow the Rules, timely, orderly and effectively perform the coding of Unique Identification, and complete the submission of the registration system and database for unique identification.

On September 29, 2020, NMPA, National Health Commission and National Healthcare Security Administration issued the Announcement on Further Promoting the Pilot and Effective Implementation of Unique Identification for the First Batch of Medical Devices which extended the scope and redefined the schedule.