China: Announcement of The Third Batch of China UDI Implementation Date

ARQon
Mar 14, 2023
2 min read

The National Medical Product Administration of China (NMPA) and the National Health Commission have announced the implementation of Unique Device Identification system (UDI) for medical devices in China. The main purpose is to identify medical devices through manufacturing, distribution and usage in China. UDI consists of Device Identification (DI), which includes license holder, model and packaging information and Production Identification (PI) includes production process, serial number, batch number, production date and expiration date.

NMPA released the first group of Unique Device Identification System (UDI) which includes the equipment for surgical, implant, imaging and blood transfusion on July 2019 as the first trial and feedback were collected on September 2019. Later, the NMPA announced the implementation date of the first batch of medical devices was 1st January 2021 and the second batch followed on 1st June 2022.

Recently, NMPA announced the third batch of China UDI for medical devices will be implemented on 1st June 2024. For continuous improvement and better management of medical devices and in vitro diagnosis systems, the third batch will cover certain medical devices classified as Class II. The products involved are:

Large clinical demand for single-use products
Medical insurance centralized products
Medical products related to cosmetology
Surgical instruments (active/passive)
Medical imaging equipment

There is 3 important requirement information for the manufacturers to alert which are the requirement of UDI labeling, the requirement of UDI database and the requirement of processing certificates.

The requirement of UDI labeling: NMPA approval is needed for UDI of any products produced on or after 1st June 2024.
The requirement of UDI database: UDI Code must be uploaded into UDI database after receiving approval. For medical devices recorded under Medical Insurance Medical Consumable database, UDI Code must be attached to the record, update the classification and code field in the database.
The requirement of processing certificates: covering on registration, changing and renewal of medical device certificates.