UDI Soon Required for All Class III Medical Devices and IVDs

On September 17, 2021, the NMPA (National Medical Products Administration) announced (No.114-2021) the plan for the implementation of UDI for the second batch of products.

The second batch of products consist of the remaining Class III medical devices and IVDs that weren’t covered in the first batch. The implementation of UDI plan for the first batch of products was first announced (No.72-2019) in October 15, 2019, and officially launched on January 1, 2021.

Highlights

According to Order 114, the Unique Identification Code requirements are:

• The UDI code must be labelled for all class III medical devices and IVDs manufactured on or after June 1, 2022.
• The UDI of the product’s smallest (innermost) packaging unit should be submitted to the UDI registration system for the applications of initial registrations, registration renewals and changes in licensing items submitted on or after June 1, 2022.
• For all class III medical devices and IVDs manufactured on or after June 1, 2022, the UDI of the product’s smallest (innermost) packaging unit should be uploaded to the UDI database before selling into the market.

By Dora Yang. Contact Cisema if you would like to learn more.