Quick reference guide - global medical device UDI requirements and timelines

By
Bethaney Lentz
-
July 26, 2022
Quick reference guide - global medical device UDI requirements and timelines

This article was last updated July 26, 2022.

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.

There are two main components to UDI requirements, labeling and database registration. Despite efforts to harmonize both labeling and database requirements across markets, countries with UDI adoption plans have added market-specific requirements.

Quick Links to country-specific sections:

General UDI labeling requirements

There are two components to a medical device UDI: the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI). The UDI is presented as a barcode label (human and machine readable) on device packaging or on the device itself and acts as the access key to all device UDI attributes.

UDI-DI: This is the static portion of the UDI which identifies the manufacturer along with the specific device version. The UDI-DI (device identifier), also known as the Global Trade Item Number (GTIN) is assigned by an approved organization, such as GS1, and contains:

  • Company prefix
  • Manufacturers internal product code
  • Check character

The UDI-DI is the primary identifier to be used in looking up device attributes in country-specific databases and is assigned prior to placing a product on the market. Note that the device identifier is different for different packaging levels of the same device.

UDI-PI: This is the dynamic portion of the UDI which is assigned by the manufacturer and identifies one or more of the following:

  • Manufacturer’s lot or batch number
  • Serial number
  • Manufacturing date
  • Expiration date
  • Other attributes as defined by country-specific regulations 

The UDI-PI actual values do not appear in country-specific databases (with the exception of the EU vigilance database).

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. For additional country-specific details, check our Ultimate Guide to the EU MDR/IVDR UDI and the Ultimate Guide to the China NMPA UDI System.

Australia UDI requirements

The Australian Therapeutic Goods Administration (TGA) has set up a technical working group to define the specific UDI labeling and data requirements, with an expected date for the regulation in January, 2023. Mandatory compliance, however, will likely not go into effect until the following year. More details about the implementation timeline and progress of the project can be found on the Australian TGA website.

Australia compliance timeline
Activity Date
Sandpit (beta) version of Australian UDI database Jun 2022 - Dec 2022
Regulation goes into effect with voluntary compliance (Class II, III, AIMD high-risk devices) Jan 2023
Mandatory compliance for implantable devices (labeling and database registration) Jul 2024

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 database, and related compliance dates, are not yet available.

Brazil compliance timeline
Device risk class Compliance dates (labeling)
Class IV Jun 2024
Class III Jan 2025
Class II Jan 2026
Class I Jan 2028

* Use of UDI labels became mandatory with this regulation in January, 2022 for coronary artery stents, drug-eluting coronary artery stents, and implants for hip and knee arthroplasty.

For more information, see the ANVISA UDI guidelines.

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. It is expected that, like most countries, Canada will add a small number of additional UDI data attributes to be required.

China UDI requirements

China’s current requirements include UDI labeling for the more complex devices, with additional device classes pending. In addition to labeling requirements, China requires that the UDI be recorded as part of a medical device registration.

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

Additional information on China UDI requirements (link in Chinese) from China State Drug Administration and Rimsys Ultimate Guide to the China NMPA UDI System.

European Union UDI requirements

UDI compliance deadlines have been delayed in the European Union, but the first UDI labeling deadlines have just passed. While 3 of the 6 EUDAMED database modules are currently available for voluntary use, EUDAMED registration is not being mandated until all 6 modules are fully functional. Mandatory compliance for UDI data entry into the EUDAMED UDI module is estimated to be mid-2026.

The first compliance deadline for UDI labeling was May 26, 2022 with the rest of the device classes rolling out through May 26, 2027.

European compliance timeline
Device risk class Compliance date
III May 26, 2022
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

For additional information, see EU UDI system and requirements.

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 on devices and the specific information that the UDI needs to include 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.

Japan compliance timeline
Activity Year
Japan’s Ministry of Health, Labour and Welfare (MHLW) published “Guidelines for Placing Standard Codes (Barcode Marking) on Medical Devices.” This was successful in encouraging barcodes on device packaging, but direct marking on devices remained very limited. 2008
JFMDA (Japan Federation of Medical Device Associations) published “UDI Operation Manual for Medical Devices,” further encouraging direct marking of barcodes on specific types of medical devices. 2016
The Pharmaceuticals and Medical Devices Act, known as the PMD act, was amended to include, among other things, UDI labeling requirements for medical device packaging.
Effective Dec 2022 and with stepwise implementation according to the type of device, bar code labeling based on the international standards shall be required for immediate containers/wrappings/retail packages of medical devices. Concretely, 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. As more information becomes available we will continue to update.
2019

Saudi Arabia UDI requirements

Saudi Arabia has allowed voluntary UDI registration since October 1, 2020, but mandatory compliance for all device classes doesn't begin until September 1, 2022. These requirements apply to both labeling and database registration.

Medical devices imported before the compliance date can be distributed for up to 1 year after the compliance date without meeting UDI requirements. This exception does not apply to the Direct Marking (DM) requirement, which is a permanent marking of the UDI on the device itself.

All UDI Requirements:

  • Class D devices – 1 year after SAUDI-D is ready
  • Class B/C devices – 2 years after SAUDI-D is ready
  • Class A devices – 3 years after SAUDI-D is ready
  • For the Direct Mark requirements – 2 years after the applicable class compliance date
Saudi Arabia compliance timeline
Device risk class Compliance dates (labeling and registration)
Class D (high risk) Sep 1, 2023
Class B & C (medicum risk) Sep 1, 2023
Class A (low risk) Sep 1, 2024

For additional information, see the Saudi Arabia guidance on UDI requirements for medical devices.

Singapore UDI requirements

Singapore is not currently requiring compliance with UDI labeling or database registration regulations. When requirements do go into effect, 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. So, for example, a company with a high-risk implantable device that requires UDI labeling and registration in November, 2022 would be allowed to continue to market devices that are not UDI compliant through May 1, 2023 (allowing local stock depletion prior to the compliance date).

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

For more information, see the Guidance on Medical Device UDI system from Singapore Health Sciences Authority.

South Korea UDI requirements

South Korea has implemented UDI labeling and database registration requirements for most device classes, with just one class pending. 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. 

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.

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

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

Taiwan UDI requirements

Taiwan has begun a phased implementation of UDI, which includes both labeling and database reporting requirements.

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 is currently mandating 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 are consumer health products, before December 8, 2022. Implantable, life-supporting or life-sustaining devices, including Class I I/LS/LS devices, are already expected to comply with GUDID submission requirements. The US FDA requires that all UDI information be entered into the US-specific GUDID database.

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

For additional information, see the FDA UDI system and requirements.

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
South Korea IMDIS UDID 40 GS1, HIBCC, ICCBBA
Taiwan TUDID 23 GS1, HIBCC, ICCBBA
United States GUDID 64 GS1, HIBCC, ICCBBA

* 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.

Additional UDI resources

Our team recently 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.

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