New Regulations for Unique Medical Device Identification in China Took Effect on 1 June 2024

Starting from June 1, 2024, medical devices listed in the third batch implementation product catalogue in China must complete registration and obtain a Unique Device Identification (UDI) in accordance with the new regulations, according to the National Medical Products Administration (NMPA) Announcement No. 22 of 2023.

Implementation of the UDI System

The Unique Device Identification (UDI) System Rules, which were established by the NMPA on October 1, 2019, aim to standardise the construction of UDIs and strengthen the lifecycle management of medical devices. Each device receives a unique identification code, and registrants must create, maintain, and assign the UDI for devices, upload data, and use the UDI to improve the overall lifecycle management of devices.

First and Second Batch

On January 1, 2021, NMPA decided to implement the UDI system for the first batch of 69 Class III medical devices, and on June 1, 2022, following the implementation for the second batch of other Class III medical devices (including in vitro diagnostic reagents), Order No. 22 of 2023 announced the third batch of products to adopt the UDI system.

Details of the Third Batch

This third batch includes high-demand single-use products, items selected for centralized procurement, and medical aesthetic products, totaling 103 types in 15 categories. The detailed catalogue can be found on the official announcement page here.

Compliance Requirements

The new regulations took effect on June 1, 2024. From that date, new registration applicants are required to submit product identifiers for the smallest sales unit in the registration system. For devices registered before June 1, 2024, registrants must provide these identifiers when renewing or amending their registrations.