Late last year, China’s NMPA outlined the need for some Class 2 products to get UDIs. The third group of products that need UDIs is over 140 products including devices like vascular suture devices, peritoneal dialysis equipment, ophthalmic instruments, blood cell analysis instruments, etc. For companies seeking device approval from June 1, 2024, the device maker should present the identification of the smallest sales unit to the registration management system. For devices approved before June 1, 2024, the device maker should submit the product identification code of its minimum sales unit to the management system once the product registration is changed or renewed.
In China, unique device identification includes both the production identification/evidence (PI) and device identification/evidence (DI). The first batch of devices requiring UDIs were implantable products in 2019.