Quick reference guide - global medical device UDI requirements and timelines

Bethaney Lentz
March 11, 2024
Quick reference guide - global medical device UDI requirements and timelines

This article was last updated March 12, 2024.

What is UDI?

Unique device identifiers (UDI) are now a requirement for medical devices marketed in the US, and are being phased in by the EU and other countries. UDI systems are intended to benefit healthcare providers, manufacturers, authorized health authorities, hospitals and institutions, and individual consumers by providing:

  • Faster discovery of possible flawed medical device information by health authorities.
  • Quicker access to recall information, and visibility into current inventory.
  • A reduction in medical errors through consistently documented product expiration dates.
  • Identification of any counterfeit products being used in healthcare facilities.
  • Assurances that information regarding an implanted device is safely retained and traceable.

UDI timeframes and deadlines vary by market and product, and have been revised multiple times in some countries. This article details the UDI deadlines for the countries which have announced specific programs, and is current as of the date of this article. Note that these dates can change as participating countries adjust their plans. We will continue to update this as more information becomes available.

Quick Links to country-specific sections:

Australia UDI requirements

The Australian Therapeutic Goods Administration (TGA) announced that mandatory compliance will be progressively phased by device classification, starting with high-risk and implantable medical devices, followed by lower risk class devices over subsequent years. Mandatory compliance will likely not go into effect until the Medical Device Regulations is updated in 2024.

Sponsors and manufacturers can choose to voluntarily comply with the UDI requirements from the date the UDI regulations take effect. Mandatory compliance will commence at a minimum of 12 months from the date the regulations take effect. The reporting database for UDI (AusUDID) is also still in the production phase.

Australia compliance timeline
Activity Date
Sandpit (beta) version of Australian UDI database Current
Regulation goes into effect with voluntary compliance (Class II, III, AIMD high-risk devices) TBD
Mandatory compliance for implantable devices (labeling and database registration) TBD

Brazil UDI requirements

On January 10, 2022, RDC 591/2021, the regulation that requires UDI labeling and database registration for devices regulated by the Brazilian Health Regulatory Agency ANVISA, came into effect. The regulation calls for rolling implementation based on risk class and the establishment of a Brazil UDI database.

In the case of reusable devices for which the UDI information is placed directly on the product, an additional two years have been added to the transition periods below. Details of the UDI reporting database, and related compliance dates, are not yet available. Additional information can be found here: ANVISA UDI guidelines

Brazil compliance timeline
Device risk class Compliance dates (labeling)
Class IV Jun 2023
Class III Jan 2024
Class II Jan 2025
Class I Jan 2027

Canada UDI requirements

Health Canada has proposed a UDI framework based closely on the international UDI guidance from the IMDRF. The current proposal involves requiring UDI labeling for all devices, with the exception of Class I low-risk devices. Health Canada intends to either develop a UDI database or modify the existing Medical Devices Active License Listing database (MDALL) to accommodate UDI data.

China UDI requirements

In addition to labeling requirements, China requires that the UDI be recorded in the China National UDI Database as part of the medical device registration. Additional information on China UDI requirements (link in Chinese) from the China State Drug Agency and  Rimsys Ultimate Guide to the China NMPA UDI System.

China compliance timeline
Device risk class Compliance date (labeling and registration)
Class III (subgroup) Jan 2021
Class III (remaining devices) Jun 2022
Class II Jun 2024 (estimated)
Class I Oct 2026 (estimated)

European Union UDI requirements

According to the initial provisions of the European MDR and IVDR regulation, industry use of EUDAMED may not be mandated until all modules are declared fully functional. In the last several months, the MDR/IVDR amendment proposal (23/01/2024) was released to suggest a gradual implementation of individual EUDAMED modules once each has been audited and declared functional. This proposal has been issued with a goal to speed up launch of the modules of EUDAMED as each is finalized to allow for industry implementation and adoption without additional, undue delay. The UDI module of EUDAMED is available for voluntary use currently and, with the provisions of the proposed amendment, could be mandatory use for industry in late-2025 with an expected transition period beginning at the time the UDI module is ready. Additional information on EU UDI system and requirements: EU UDI system and requirements.

European Union compliance timeline
Device risk class Compliance date (labeling)
Class III and Class II implantables Dec 31, 2027
Class IIa and IIb May 26, 2023
Class I May 26, 2025
Class III - reusable May 26, 2023
Class IIa and IIb - reusable May 26, 2025
Class I - reusable May 26, 2027
Class D (IVD) May 26, 2023
Class B and C (IVD) May 26, 2025
Class A (IVD) May 26, 2027

India UDI requirements

At the end of 2021, the Indian Ministry of Health and Family Welfare delayed the implementation of UDI requirements in India and no new deadline has yet been put in place. Originally, Rule 46 of Medical Device Rule 2017 was set to require UDI labeling by January 1, 2022 for medical devices approved for manufacture, sale, distribution, or import in India. Details on how the UDI needs to be displayed and the specific information that needs to be included have not yet been released.

Japan UDI requirements

Japan was an early promoter of standardized barcodes, but is still working towards harmonizing their requirements with global UDI expectations.

As of Dec 2022,  according to the type of device, bar code labeling based on the international standards is required for immediate containers/wrappings/retail packages of medical devices. It is expected that barcodes would be displayed on every pharmaceutical and medical device in unit of use for patients. Also, safety measures using bar code labeling at clinical settings shall be promoted, as well as registration of production information in the database by MAHs.

Saudi Arabia UDI requirements

Saudi Arabia has allowed voluntary UDI registration since October 1, 2020, but mandatory compliance for class B, C and D devices went into effect September 1, 2023. These requirements apply to both labeling and database (SaudiDI) registration.

Medical devices imported before the compliance date may be distributed without UDI information until one year after the date of full enforceability. This exception does not apply, however, to the Direct Marking (DM) requirement, which is a permanent marking of the UDI on the device itself. For additional information, refer to the Saudi Arabia guidance document.

Saudi Arabia compliance timeline
Device risk class Compliance dates (labeling and registration)
Class D (high risk) Sep 1, 2023
Class B & C (medium risk) Sep 1, 2023
Class A (low risk) Sep 1, 2023

Singapore UDI requirements

Singapore is requiring compliance with UDI labeling or database registration regulations based upon classification and a phased in approach. Singapore will accept UDI labels for devices already marketed in the U.S. and the EU, otherwise the UDI will need to comply with all of Singapore’s HSA guidelines, including partnering with an HSA-designated UDI issuing entity. Singapore is also allowing companies a 6-month grace period for medical devices imported before the November deadlines listed below.

Guidance on Medical Device UDI system (GN-32-R2)

Singapore compliance timeline
Device risk class Compliance dates (labeling and registration)
High-risk implantable Nov 2022
Class D Nov 2024
Class C Nov 2026
Class B (medium risk) Nov 2028
Class A Not required, voluntary

South Korea UDI requirements

UDI compliance is mandatory and was implemented by Article 20 of Medical Device Act (No. 14330) and Article 54-2 of Enforcement Regulations of Medical Device Act (No. 1512). Note that South Korean regulations refer to “Integrated Medical Device Information System,” or IMDIS, which is their UDI database and “Medical Device Standard Code,” which is the UDI code itself. As part of the introduction of UDI, South Korea has also mandated that manufacturers provide a device monthly supply history report, required 1 year from the UDI compliance dates.

South Korean regulations:  Guidelines for generating UDIs, Medical Device Act No. 14330 and the Regulation on KGMP No 2016-156 (links in Korean).

South Korea compliance timeline
Device risk class Compliance dates (Labeling and registration)
Class IV (high risk) Jul 2019
Class III (serious risk) Jul 2020
Class II (potential risk) Jul 2021
Class I (lower risk) Jul 2022

Taiwan UDI requirements

Taiwan has already implemented UDI regulations, which includes both labeling and database reporting requirements. The UDI reporting database is referred to as Taiwan UDID (TUDID) and has 23 required data elements. If medical materials meet one of the following conditions, however, then they could be exempt from UDI: Customized medical devices, special medical equipment for export and non-implantable medical device components in the medical device package and in vitro diagnostic medical device package for single use only and not used separately and sold. Read more in the Guidance document from Taiwan FDA.

Taiwan compliance timeline
Device risk class Compliance dates (labeling and registration)
Class III – implantable Jun 2021
Class III – medical devices Jun 2022
Class II Jun 2023

United States UDI requirements

The United States mandates compliance with both labeling and database requirements for all devices. The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices (I/LS/LS), regardless of whether they were consumer health products, before December 8, 2022.

Implantable, life-supporting or life-sustaining devices, including Class I I/LS/LS devices, should also be complying with GUDID submission requirements. The US FDA requires that all UDI information be entered into the US-specific GUDID database. For additional information, see the FDA UDI system and requirements.

United States compliance timeline
Device risk class Compliance dates (labeling and registration)
Class III Sept 24, 2014
Class II Sept 24, 2016
Class II - reusable Sept 24, 2018
Class I Sept 24, 2018
Class I - reusable Dec 8, 2022

Country-specific UDI databases

Each country has their own UDI database and varying requirements for the data stored in those databases. There is overlap in the data required among the various UDI databases, but each country also has unique data they require.  

In addition, countries require that UDI-DI information be provided by “issuing entities.”  Note that with the exception of China, all countries accept GS1, HIBCC, and ICCBA as issuing entities.

UDI databases
Country Database Data attributes * Accepted issuing entities
Australia AusUDID tbd** tbd**
Brazil to be established 21 GS1, HIBCC, ICCBBA
China CUDID 51 GS1 China, ZIIOT, Ali Health
European Union EUDAMED 130 GS1, HIBCC, ICCBBA, IFA
Saudi Arabia Saudi-DI 35 GS1, HIBCC, ICCBBA
Singapore SMDR 13 GS1, HIBCC, ICCBBA
United States GUDID 64 GS1, HIBCC, ICCBBA

Note: * Data attributes are approximations based on country UDI requirements and include mandatory, optional, mandatory if applicable, and country database auto generated elements.

** Expected to be similar to US GUDID requirements.

Keeping pace with UDI regulations

Keeping track of country-specific UDI requirements, implementation timelines, and affected devices can be a big challenge to RA teams—especially because the information is scattered across many sources and hard to find. In this guide, we have consolidated timeline information and device class requirements across multiple countries. While we make every effort to provide accurate and up to date information, it's always advised to check the government website for the country in question.

Additional UDI resources

Our team discussed country-specific UDI requirements and strategies that regulatory affairs teams can use to better manage UDI data in an in-depth webinar. For additional information on UDI requirements, you can watch the webinar replay here, or review our Ultimate Guide to the EU MDR/IVDR UDI and the Ultimate Guide to the China NMPA UDI System.

Similar posts

Evolving global cybersecurity regulations: Challenges and opportunities for medtech teams
Evolving global cybersecurity regulations: Challenges and opportunities for medtech teams
Key steps to help you streamline regulatory process management
Key steps to help you streamline regulatory process management
Rimsys UDI Overview
Rimsys UDI Overview