Global UDI updates in recent months

Staying up to date with Unique Device Identification (UDI) regulations is crucial for global compliance. Various regulatory agencies, including the TGA, ANVISA, NMPA, and the European Commission, have recently introduced significant updates to UDI requirements. Our latest insights highlight key changes that could impact your compliance strategy.

Country	UDI Requirements	Recent Updates
Australia (TGA)	2022 Jun – AUSUDID sandpit (beta) general use, testing	On November 27, 2024, TGA deployed a significant enhancement package to the AusUDID Pre-Production environment. The Pre-Production version is now open again for sponsor use and feedback.Machine-to-Machine (M2M) submissions are still being tested.
Australia (TGA)	2023 Jan – Regulations and Guidance in effect	As of 12th December 2024, the Therapeutic Goods Administration (TGA) has published the draft guidance document titled Complying with the Unique Device Identification regulations for medical devices for external review.
Need expert support for UDI compliance? Ensure smooth implementation and adherence to the latest regulations explore our UDI Solutions.
Brazil	2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI data reported to RNI by healthcare provider	On January 10, 2022, Brazil’s National Health Surveillance Agency (ANVISA) implemented the Unique Device Identification (UDI) system through Resolution RDC 591/2021. This regulation mandates that certain high-risk medical devices, including coronary artery stents and hip and knee arthroplasty implants
Brazil	2021 Feb – UDI System Publication	ANVISA has revised its UDI regulations through RDC 884/2024, an amendment to RDC 591/2021, which became effective on June 1, 2024. This amendment revised specific provisions, including the deadlines and requirements for attributing and affixing UDI
China	GS1, ZIIOT and AHM.	GS1, ZIIOT and AliHealth.
European Union	Currently EUDAMED is voluntary, and its mandatory use date has been postponed multiple times.	The EUDAMED UDI/DEV module will become mandatory 6 months after its functionality is confirmed in the OJEU. EUDAMED UDI module has been available for voluntary use since October 2021. Devices already on the market must be registered within 12 months after the module’s functionality is confirmed. New devices (excluding custom-made, investigational, and performance study devices) must be registered in the UDI/DEV module before placing the first sales unit on the market after the mandatory use date

As UDI regulations continue to evolve worldwide, ensuring compliance with the latest updates is essential. Stay ahead of regulatory changes and streamline your UDI implementation with expert guidance. Contact us to navigate the complexities of UDI compliance efficiently.