UDI first-batch implementation

On 17 September 2019, the National Medical Products Administration (NMPA) circulated a call for comments on the “Notice to matters related to the first batch implementation of UDI for medical devices”1. The deadline for comments is 25 September 2019.

Following the publication of the regulations for the UDI-system on 27 August 2019, the draft notice specifies the first step in the step-by-step implementation plan for UDI in China. It includes a product catalogue for the first batch of products requiring UDI, covering certain high-risk, class III devices.