NMPA Continues UDI Implementation in China with Third Batch Release

Third Batch of UDI Implementation in China Includes Some Class II Devices

On February 17, 2023, the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration issued an announcement regarding the implementation of the third batch of unique device identification (UDI) of medical devices in China.

This announcement is aimed at further implementing the “Regulations on the Supervision and Administration of Medical Devices,” the “Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Treatment of High-value Medical Consumables,” and the key tasks of the State Council to deepen the reform of the medical and health system.

The following 103 types of class II medical devices belong to the third batch and will need to have UDI labeling by June 1, 2024.

Please contact Asia Actual today to learn more about your product’s UDI requirements or if you’re interested in entering the Chinese market.

Third Batch UDI Implementation Update: 103 Class II Medical Devices

According to the announcement, some class II medical devices, such as single-use products with large clinical demand, selected products in centralized procurement, and medical cosmetology-related products, have been determined as the third batch of medical device UDI implementation varieties. In total, there are 103 types of class II medical devices (see the full list below).

The schedule for the implementation of the third batch of UDI of medical devices is as follows:

1. Assignment of a unique identifier: Medical devices produced from June 1, 2024, shall have a UDI for medical devices, and the third batch of products with UDI that have been produced before may not have a UDI.
2. Submit to the unique identifier registration system: For those who apply for registration from June 1, 2024, the registration applicant shall submit the product identification of the smallest sales unit of the product in the registration management system.
3. UDI database submission: For medical devices produced from June 1, 2024: Before they go on the market, the registrant shall upload the product identification and related data of the minimum sales unit, as well as the higher-level packaging to the unique medical device identification database.

The announcement also includes relevant requirements for medical device registrants, operating companies, and medical institutions, such as establishing a sound traceability system based on the UDI and actively applying unique identifiers in their business activities and clinical practice.

This announcement by the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration regarding the implementation of the third batch of UDI of medical devices is a significant step towards strengthening the supervision and management of medical devices and promoting the development of the medical and health system.