UDI World Overview

The UDI (Unique Device Identification) field is still evolving and more or less advanced depending on the country.
If you are in any way involved in the medical device business, it may be relevant for you to stay up to date with regulations and deadlines around the world.

That’s why Europe IT Consulting provides you with a global overview that reflects the status as of July 2023.

Country	Authority	Classification (low-high)	Stand of the UDI Link for more information
USA	FDA (Food and Drug Administration)	I, II, III	UDI implemented For products that require UDI labeling, legacy FDA identification numbers such as the National Health Related Item Code (NHRIC) and National Drug Code (NDC) may no longer be used on product labels or packaging. The product must be labeled with a UDI by September 24, 2023. – This does not apply to Class I devices with a Universal Product Code (UPC), as this can serve as a UDI. More information here.
EU	European Commission	I, II, III, A, B, C, D	UDI implemented Regulation (EU) 2023/607 extends the transitional provisions of the MDR to avoid medical device bottlenecks and give manufacturers more time to comply with MDR certification. The deadlines for the application of the UDI : May 26, 2021: Class III and implantable devices May 26, 2023 for class IIa and IIb devices May 26, 2025 for class I devices Dec. 31, 2027 for Class III and Class IIb implantable devices (except for certain devices for which the MDR provides exemptions) December 31, 2028 for other class IIb devices and class IIa, Im and Is devices. More Information here.
China	National Medical products Administration (NMPA)	I, II, III	UDI implemented The third set of UDI labeling requirements for medical devices in China will take effect on June 1, 2024, following the previous implementation of Class III devices. In addition, the UDI implementation program will be extended to selected Class II medical devices to further improve surveillance and management. More Information here.
United Kingdom	MHRA (Medicines & Healthcare products Regulatory Agency)	I, II, III	UDI not implemented Since May 26, 2021, the United Kingdom is considered a third country on the EU market. CE marking and certificates will be accepted for the UK market until June 30, 2023. More Information here.
Japan	Ministry of Health, Labor, and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA)	I, II, III, IV	UDI implemented The companies have to comply to the Pharmaceuticals and Medical Devices Act (PMD Act). Japan was one of the first countries to advocate for a standardized UDI, but is still struggling to align its requirements with UDI expectations on a global scale More Information here.
Singapur	HSA (Health Sciences Authority)	A (nicht steril), A (steril), B, C, D	UDI not implemented Currently, there are no UDI labeling or database registration requirements, but once the UDI goes into effect, the requirements must comply with HSA guidance and be implemented in a UDI issuing authority. Simplified registration process for products already approved in the U.S. and the European Union. More Information here.
Schweiz	Swissmedic	A, B, C, D	UDI implemented Considered a third country on the EU market since May 26, 2021. Severe and numerous consequences for manufacturers, importers and distributors, especially EU manufacturers. The following transition periods apply: Class D products: December 31, 2022 Class B and C products: March 31, 2023 Class A products: July 31, 2023
Saudi-Arabien	SFDA (Saudi Food and Drug Administration)	A, B, C, D	UDI implemented Import regulations will take effect at different times depending on the classification: Class D: September 1, 2023 Class B and C: September 1, 2023 Class A: September 1, 2024 More Information here.
Australien	TGA (Therapeutic Goods Administration)	I, IIa, IIb, III	UDI not implemented The Australian healthcare sector lags behind other sectors, particularly in the supply chain (data and business processes are poorly managed), causing a number of problems. The introduction of UDI is intended to be a catalyst for change in the healthcare sector. The AusUDID pre-production environment is currently being prepared, but the original launch date of July 1, 2023, has been postponed to a later date. The UDI policy and regulations are currently being drafted and have not yet been approved by the Australian government. More Information here.
Kanada	Health Canada	I, II, III, IV	UDI not implemented Health Canada has proposed a UDI framework that is aligned with the IMDRF international UDI guidelines. The proposal includes UDI labeling (except for Class I). Health Canada plans to either develop its own UDI database or adapt the existing Medical Devices Active License Listing (MDALL) to include UDI data with some additional data attributes More Information here.
Südkorea	Ministry of Food and Drug Safety (MFDS)	I, II, III, IV	UDI implemented Import regulations will come into force at different times depending on the classification (according to risk level). Class IV medical devices: July 1, 2020 Class III medical devices: July 1, 2021 Class II medical devices: July 1, 2022 Class I medical devices: July 1, 2023 More Information here.
Brasilien	ANVISA (Brazilian Health Regulatory Agency)	I, II, III, IV	UDI implemented ANVISA has set the following schedule for UDI data import: Class IV: June 2024 Class III: January 2025 Class II: January 2026 Class I: January 2028 More Information here.

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