Global BackgroundThe Unique Device Identifier (UDI) is an essential tool for medical devices. It enhances clinical safety, provides a solid tracking system for corrective actions, and closely links the supply chain of medical devices to their production. While UDI's history goes back to 2007 that FDA Amendment Act set up regulatory basis for UDI, the first UDI-specific requirement was published by FDA in 2013 and implement a harmonized global platform has only recently been fully rolled out. Managing UDI for various markets is a complex task for many device manufacturers. While regulatory authorities try to establish a common basis, localized implementation is heavily influenced by each market's core legislation, policy, timeline, submission approach, and data management requirements.
China-Specific UDI RequirementsChina started its UDI journey later than the US and European Union but pushed forward its implementation quickly. In 2019, the National Medical Products Administration (NMPA) and the National Health Commission jointly issued the "Pilot Work Plan for the Unique Device Identification System of Medical Devices." Followed by "Rules for the Unique Device Identification System of Medical Devices" further specifies the implementation details. These working documents clarify that medical device registrants listed in the certificate are responsible for generating, assigning, and managing UDI’s, registering data in the UDI database, and ensuring data accuracy, integrity, and completeness.
The UDI system in China The UDI system in China consists of three main componentsUDI code, UDI data carrier, and UDI database. UDI code comprises a Device Identifier (DI) and a Production Identifier (PI). DI is a fixed code assigned to identify the manufacturer, medical device specifications, and packaging. PI contains variable information such as medical device serial numbers, production lot numbers, production dates, and expiration dates, all depending on the setup. UDI data carriers are the medium to store/transmit UDI data, such as one-dimensional barcodes, two-dimensional barcodes, radio-frequency identification tags (RFID), etc. The UDI database stores the identification of medical device products and related information.
From the implementation level, NMPA published the first batch of UDI-required products in 2021, covering 69 Class III medical devices categories. The second batch released in 2022 required all the remaining Class III medical devices, plus some in-vitro diagnostic reagents, to bear UDI on their labels. The third batch will include 103 types of class II disposable products in large sales volume, those enrolled in China centralized bulk procurement, and medical cosmetology-related products starting June 1st, 2024.
Recognized Agency in China
Currently, three agencies are recognized for issuing UDI in China: GS1, ZIIOT, and Ali Health. GS1 seems to be the only global market entry service provider for foreign device manufacturers. GS1 China recognize the UDI assigned and labelled from other GS1 Member Organizations, however, foreign registrants need to follow an extra step to populate the data locally.
Challenges for foreign registrants
Foreign registrants face several challenges when managing the local data portal. Before placing the product on the market, they must maintain two central systems: the NMPA UDI database UDID and the China GS1 database. Both websites are in Chinese only. As UDID is a new and evolving system, some foreigners do not fully understand how it works, what information needs to be submitted, and how to maintain it over time. Data attributes also vary, and one dataset may not fit various countries. The second challenge is to meet different implementation timelines across countries. China has required that all class III devices are assigned with and bear UDI on the label since 2021, and some class II devices shall bear UDI from June 1st, 2024. However, European
manufacturers' mandatory UDI and device registration dates depend on the EUDAMED access date and the product's MDR certification date. This issue may also impact product distribution in China if manufacturers are from other markets whose implementation time is later than that of China.
Last, foreign manufacturers need to stay informed about the latest developments from provincial regulatory departments and hospital-specific requirements involved in product sales. Given UDI's phased and incremental implementation in China, the progress and specific UDI implementation vary among provinces and cities.
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