The unique device identification (UDI) of specific categories of class III medical devices was implanted from 1st Jan 2021, while the UDI of other class III medical devices as well as IVDs were implanted from 1st June 2022, which were known as the second batch of the implementation of the UDI.
In order to put the <Notice by the General Office of the State Council of Issuing the Reform Plan for the Control of High-value Medical Supplies (国务院办公厅关于印发治理高值医用耗材改革方案的通知)> into effect thoroughly, the China NMPA decided to implement the UDI of specific categories of class II medical devices as the third batch of implementation of the UDI. The relevant issues are announced as follows:
- 1. Scope
The scope of the 3rd implementation is decided according to the risk of the device, e.g., single-use devices with high demand, products selected as centralized procurement, and aesthetic medical devices. For specified categories, please refer to the attachment.
- 2. Progress Arrangement
For the medical devices listed in the 3rd implementation, registrants should process the following tasks in time.
- (1) Giving UDI code:
Devices manufactured after 1st June 2024 shall be given a UDI. Devices listed in the 3rd implementation which are manufactured before the aforementioned date are acceptable without a UDI. The manufacturing date is subject to the device label.
- (2) Submitting the UDI to the registration system:
For devices registered after 1st June 2024, registrants shall submit the UDI of the smallest selling unit to the registration system. For devices registered or approved before, registrants shall submit the UDI when applying for renewal or amendment.
- (3) Submitting relevant information to the UDI database:
For devices manufactured after 1st June 2024, registrants shall submit the device label of the smallest selling unit and package of higher level based on the related standards or requirements as well as the related data to the UDI database before placing them on the market. This is intended to ensure the data is true, accurate, complete and traceable.
3. Relevant Requirements
● Registrants should build a traceability system based on the UDI to execute product recall, tracking, tracing, and other related work.
- ● Companies should apply the UDI in their business activities, such as entering and releasing from the warehouse with codes and tracing the product in circulation.
● Medical institutions should apply the UDI for clinical use, payment, settlement and reimbursement, realizing the traceability of products in clinical.
● Code issuing agencies should formulate standards and guidelines for the UDI, guide registrants to create and assign UDI, and verify the readability of the UDI in circulation.
● Provincial medical products administrations should strengthen the training for UDI-related work and improve the registration system when implementing the requirements.
NMPA Announcement on the Third Batch of Implementation of the UDI of Medical Devices (2023 No. 22)
● NMPA Announcement on the Third Batch of Implementation of the UDI of Medical Devices (2023 No. 22)