Update on Global UDI Requirements
The global implementation of UDI brings numerous benefits to various stakeholders, including:
- Improved Patient Safety.
- Streamlined Regulatory Compliance
- Enhanced Supply Chain Management
- Facilitated Post-market Surveillance
Global Implementation of UDI
The adoption of UDI is becoming increasingly important on a global scale. Various countries are in different stages of implementing UDI regulations, aligning with local requirements and international standards such as those set by the International Medical Device Regulators Forum (IMDRF). Below is a summary of countries that have implemented or are in the process of implementing UDI
| Country/Region | UDI database | Timelines | UDI status |
|---|---|---|---|
| United States (FDA) | GUDID (Global Unique Device Identification Database) | Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements.This includes the prohibition of using legacy FDA identification numbers (NHRIC and NDC numbers) on device labels.The enforcement policy regarding the use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers applies only to devices labeled before September 24, 2023 | Implemented |
| European Union (EC) | EUDAMED (European Databank on Medical Devices) | The obligation to submit UDI data to the EUDAMED database takes effect 24 months after the system is fully functional. Timelines for placing UDI carriers and direct marking on device labels vary by class, with deadlines ranging from May 2021 to May 2027, depending on the device type and classification under MDR and IVDR regulations | Implemented |
| China (NMPA) | NMPA (National Medical Products Administration) Medical Device Unique Identiication database | China’s UDI system is being introduced in stages,starting with Class III devices on January 1, 2021, and expanding to include Class II devices by June 1, 2024, with full implementation for Class I devices by 2026. | Implemented |
| Japan (PMDA) | UDID (Unique Device Identification Database) | As of Dec 2022 According to the type of device, barcode labelling based on the international standards is required for immediate containers/wrappings/retail packages of medical devices | Implemented |
| Brazil (ANVISA) | Brazil’s UDI database development is still in progress | ANVISA recently updated its UDI regulations with RDC 884/2024, which came into force on June 1, 2024 and UDI will be implemented for Class IV devices by July 10, 2025; Class III devices by January 10, 2026; Class II devices by January 10, 2027; and Class I devices by January 10, 2028. | Implemented |
| Singapore (HSA) | Singapore Medical Device Register | Phase 1 by November 1, 2022, for high-risk devices, Phase 2 by November 1, 2024, for Class D devices, Phase 3 by November 1, 2026, for Class C devices, and Phase 4 by November 1, 2028, for Class B devices. All devices must display UDI by the compliance dates, with a six-month grace period to deplete any medical devices that they may have imported before the compliance date and that are still in their current supply chain. | Implemented |
| Saudi arabia (SFDA) | Saudi Arabia UDI Database – (Saudi-DI) | September 2023 for medium-risk (Class B & C) high-risk (Class D) devices and September 2024 for Low-risk (Class A) devices. The optional registration for all device types began on October 1, 2020, following the launch of the UDI database (Saudi-DI). | Implemented |
| South Korea (MFDS) | Integrated Medical Device Information System (IMDIS) | July 1, 2019, for Class 4 devices, and expanded to Class 3 devices by July 1, 2020, Class 2 devices by July 1, 2021, and Class 1 devices by July 1, 2022. | Implemented |
| Taiwan (TFDA) | Taiwan UDID (TUDID) | Class III implantable devices require UDI by June 1, 2021; Class III devices by June 1, 2022; and Class II devices by June 1, 2023. | Implemented |
| UK (MHRA) | MHRA plans to develop its own UDI database | MHRA announced a roadmap for future medical device regulations, with stakeholder discussions on unique device identification (UDI) set for the second half of the year 2024. | Under process |
| Canada (Health Canada) | Health Canada is reviewing the possibility of setting up a UDI database. | Health Canada is studying the feasibility of implementing a UDI system for medical devices, in line with global standards. | Under process |
| Australia (TGA) | Australian UDI Database (AusUDID) | Australia is currently in the process of finalizing the UDI regulations and collaborating with sponsors regarding UDI requirements.TGA will announce the implementation timeframes and compliance dates once they are confirmed. | Under process |
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