Adoption of UDI by Select Countries: Similarities and Differences

To review the basics of UDI and building a UDI program, start by reading Part I of this two-part series.

Today, the world is attempting to align to a single approach for unique device identification (UDI). This rule requires medical device manufacturers to label their products through a UDI with human-readable and machine-readable forms of the device type and production variables, the UDI-Device Identifier (UDI-DI) and UDI-Production Identifier (UDI-PI), respectively. 

Looking for more insights into global UDI alignment? Author Mark Agostino presented the recent webinar, “Unique Device Identification | Aligning to a Single Approach.

UDI webinar banner - January 2022 - download

Failure to attain alignment limits the ability of global manufacturers and regulators to effectively react to product quality issues and identify postmarket surveillance trends. 

It is an important topic for the medical device industry and worthy of in-depth coverage and discussion. The following is a deep dive into the similarities and differences of UDI adoption by select countries. Specifically, what are these countries doing to implement UDI and align with current regulatory thinking on the topic, including:

  • Which countries follow the guidelines created by the International Medical Device Regulators Forum (IMDRF)?
  • What are the various issues with implementation they are dealing with?
  • How do the data attributes differ in various countries’ UDI databases?

At the AAMI/FDA/BSI Virtual International Conference on Medical Device Standards and Regulations, BSI Sector Lead-Medical Devices Lena Cordie-Bancroft answered these questions and more as part of her presentation on the implementation status of UDI for several countries.

Australia

One of the countries moving forward with UDI implementation is Australia,  Cordie-Bancroft noted.

As described in Figure 1, the Therapeutic Goods Amendment Act of Australia released in February 2021, implemented UDI in accordance with IMDRF guidelines. The Act was informed by work completed by the U.S. FDA and other regulatory authorities, along with the EU Medical Device Regulation (EU MDR). Cordie-Bancroft explained two public consultation sessions were held to solicit feedback on the governing regulation. 

Figure 1 Australia UDI
FIGURE 1 | Australia UDI

In addition, she emphasized the AusUDID (Australian UDI database) data elements will be similar to the EUDAMED and FDA requirements. She explained that “for a manufacturer`s sustainable global UDI system, you are able to link the data from the European Union, United States, Australia’s TGA, and various other countries.”

By recognizing the GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBA) issuing agencies, Australia is implementing a UDI system that not only works for that country but also aligns with other countries. The mutual recognition agreement between Australia and the European Union has furthered the synergy between the two countries, as demonstrated by the data elements in their respective UDI databases.

Brazil

Next, Cordie-Bancroft stated the publication of the UDI regulation by the Brazilian Health Regulatory Agency (ANVISA) was expected to happen by the end of 2021 (Figure 2). At this time, there is no confirmation that the ANVISA UDI regulation 1051/2021 has been published.

Figure 2 Brazil UDI
FIGURE 2 | Brazil UDI

The timeframe for compliance with this regulation is a function of the date of publication. The plan is to roll out UDI in Brazil over a six-year period from the point of publication, as shown in Figure 2.

One of the key points she describes in her presentation is that Brazil will follow the Global Medical Device Nomenclature (GMDN) code that aligns with the U.S. FDA but not the European Union, which uses a European Medical Device Nomenclature (EMDN) coding system.

Therefore, manufacturers need to be aware of this difference when comparing data in Brazil’s UDI database to UDI data from other countries. The challenge in the nomenclature for the coding of medical devices is that countries do not always use the same system. A country can choose to use:

  • GMDN or EMDN
  • A combination of GMDN and EMDN
  • A unique national system
  • No system at all

The alignment of the UDI approach needs to overcome this challenge. Particularly, manufacturers need to be cognizant of the fact that Brazil recognizes the GS1 and HIBCC issuing agencies, but not the ICCBBA issuing agency in developing their regulatory and production strategies.

Also,  Cordie-Bancroft pointed out custom-made devices and investigational devices will be exempt from UDI requirements under Brazilian regulation. Postmarket vigilance notifications will require UDI information in the reports.

In summary, Brazil is working to establish its own UDI database with aspects that align with other countries but, overall, its system is unique. Manufacturers need to keep these differences in mind when comparing UDI database information in Brazil.

China

“In addition to the standards, China has been doing a lot of work on UDI,” Cordie-Bancroft said. 

As shown in Figure 3, China implemented a UDI system in January 2021 for high-risk devices. This system covers devices manufactured after the date of implementation (devices manufactured before the date of implementation do not fall within the scope of China’s UDI requirement). Cordie-Bancroft highlights that this is a positive outcome for manufacturers since no rework of devices is required. 

Figure 3 China UDI
FIGURE 3 | China UDI

In China, all parties, including the public, will have access to the medical device identifier database. Also of note, China has four issuing agencies for UDI.

 Cordie-Bancroft points out GS1 China may differ from other GS1 agencies yet remains “compatible.” Compatibility helps interpret UDI data between different countries that use the GS1 issuing agency, and China does recognize other issuing agencies based in China. Furthermore, unlike the United States and European Union, China does not accredit the issuing agencies.

China established the infrastructure for a UDI program. However, it needs to expand the program to include medium and low-risk medical devices. It is important that manufacturers are aware of the potential difference in attributes of the data existing in China’s database.

European Union

UDI is currently a big topic for the European Union. Cordie-Bancroft’s first point, as shown in Figure 4, is that all devices need to have a Basic UDI and a UDI-DI assigned as of May 2021. The higher levels of packaging need to be assigned a UDI in accordance with the timeline requirements noted in the table.

Figure 4 EU UDI
FIGURE 4 | EU UDI

There are two modules within EU MDR 2017/745 that describe the regulatory requirements for UDI, effective October 2021:

  1. Article 27 indicates the requirements for the UDI system
  2. Article 28 indicates the requirements for the UDI database

In addition to the requirements stipulated in EU MDR, there are a number of Medical Device Coordination Group (MDCG) guidance documents on the topic of UDI. In particular, MDCG 2021-19 Guidance note integration of the UDI within an organization’s quality management system is very helpful for manufacturers intending to market devices in the European Union.

Cordie-Bancroft emphasized the necessity to “keep on top of the various MDCG guidance documents as they are very helpful and informative in walking through questions” related to UDI.

Japan

Japan continues to be at the forefront of traceability. As noted in Figure 5, Japan released the Pharmaceuticals and Medical Devices Act of 2019 based upon IMDRF requirements. Therefore, Japan’s UDI program possesses a number of similarities to the U.S. and EU programs. 

Figure 5 Japan UDI
FIGURE 5 | Japan UDI

Also, GS1 is the issuing agency for Japan. Thus, the data being collected in their UDI database aligns with other countries using GS1. As noted in the Act, UDI must be present on the packaging for all medical products.

Contact us to see how medical device manufacturers can pull actionable insights around UDI-related FDA 483 observations.

Redica Systems tour

Saudi Arabia

Cordie-Bancroft was pleased to introduce the discussion of UDI in Saudi Arabia, describing the Saudi Food and Drug Authority (SFDA) guidance as “very clean and easy to understand.” As noted in Figure 6, the guidance was updated in September 2020, while the SFDA database became effective in October 2020.

Figure 5 Saudi Arabia UDI
FIGURE 6 | Saudi Arabia UDI

The MDS-G34 guidance adopted many of the basic definitions from the EU MDR and U.S. FDA concerning data attributes. Cordie-Bancroft specifically pointed out the guidance states “the barcode shall be verified according to the appropriate ISO/IEC standard,” which supports an expectation that a barcode verification should be conducted for the medical device UDI. Also, Saudi Arabia recognizes the same issuing agencies as the United States and European Union.

Another key point of the guidance is that all healthcare systems within the Kingdom of Saudi Arabia need to incorporate UDI. This is a very proactive stance, going even further than the systems employed in the United States and European Union. 

In summary, the UDI system for Saudi Arabia aligns with aspects of those in the European Union and the United States. The SFDA has even taken an additional step to harmonize UDI utilization throughout its healthcare system.

United States

In comparison to other countries, the U.S. UDI system is advanced (Figure 7). By September 2022, all devices in the United States should have:

  • UDI in their labeling
  • Data submitted to the FDA’s Global Unique Device Identification Database (GUDID)
  • Direct parts with UDI marking, where applicable
Figure 7 U.S. UDI
FIGURE 7 | U.S. UDI

In summary, the UDI system for the United States continues to lead and set the standards for those in other countries.

Conclusion

The breadth of variability in the adoption of UDI and assimilation within the countries assessed by  Cordie-Bancroft in her presentation is evident. Manufacturers supplying regulated medical devices to the United States, European Union, China, Saudi Arabia, and Japan use the GS1 standards to implement the UDI requirements, however, regulations and practices vary.

While the options for selecting an issuing agency that is recognized are consistent across several countries, the selection of an issuing agency recognized by various countries is important for the countries you intend to market.

The multiple options for adoption of UDI that exist impact the information held in a UDI database. Because of this, manufacturers need to not only be aware of the differences that exist from country to country but also need to have a UDI program and quality management system agile enough to accommodate these potential variations.

Additional Resources

UDI Compliance for Medical Devices: Part I

Postmarket Medical Device Surveillance at CDRH: Part I

Postmarket Medical Device Surveillance at CDRH: Part II

EU MDR and Economic Operators for Medical Devices

Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar: Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Presented by Jerry Chapman on October 29, 2020

What you will learn:

  • A comparison of 483 observations in FY2019
  • Top 10 Russian Ministry of Health inspection findings
  • Top 10 FDA Warning Letter findings
  • Top MHRA inspection findings
Redica Systems Enforcement Analytics

Get help choosing the right CRO.

Enter your email address and someone will contact you shortly to customize your insights.

Experience the Power of Redica Systems

Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options.

INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Redica Systems Enforcement Analytics

Evaluate Your CDMOs

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Compare the inspection history of your CDMO sites.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Compare the enforcement history of your CDMOs.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Monitor compliance at your Clinical Investigator sites.

Enter your email address and someone will contact you shortly to get you started.

Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore enforcement trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore observations and trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to run your custom report.

Redica Systems Enforcement Analytics

Compare two companies of your choice.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Download the Special Report

Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Panel Discussion – Remote Audits

Panel Discussion opt in image

Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica_Vert_Periwinkle_RGB_Large

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need to prepare for your next inspection.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

Champion of Change - 3Cs to Success

Webinar: Champion of Change - 3Cs to Success

Presented by Steve Greer on June 23, 2020

What you will learn:

  • The 3C Model to become a champion of change
  • How to identify game-changing habits and the steps to implement them
  • Ways to develop greater purpose-centered leadership
  • How to generate awareness along with actions to create changes in how you think about challenges and change putting you on a path to lead change successfully in your organization
  •  

Download the Special Report

5 GMP Case Studies Report

What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

Download the Special Report

Quality Week report sidebar

What You Will Learn from This Report:

How a major pharmaceutical company designed a program to train future leaders in quality

An industry-led initiative to advance the state of quality in the pharma industry

A pharma GMP leader’s tips for supporting quality culture within an organization

An update on FDA’s Quality Maturity Model

Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

What you will learn:

  • Examples of essential laboratory actions to remain compliant during the pandemic
  • Recent data integrity non-compliance findings and trends
  • Essential strategies to find, understand, and leverage regulatory non-compliance data

Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
  • Best practices for quality culture, including case studies with lessons learned

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

Download the Special Report

Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

Download the Special Report

5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

Experience the Power of Redica Systems

Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

Index Information Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

Strengthen Datasets Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

Analyze & Interpret Patterns Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Download the 510(k) Sample

What You Will Learn from This Sample:

See how a 510(k) submission is structured

Find out what information to include

Review correspondence between sponsor and FDA

Redica Systems Enforcement Analytics

Unlimited Access to Reports and Data

Enter your email address and someone will contact you shortly.

A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity
Redica Systems Enforcement Analytics

Upgrade your CDMO management strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
  •  

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Let us know who you are and we’ll be in touch to answer all of your questions and get you started.

Redica Systems Enforcement Analytics

Keep up with the latest Regulatory Developments on Clinical Trials

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save your team valuable time when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save time and Resources when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Get immediate access to the news that matters to your sites.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

See how we can help you eliminate yet another spreadsheet.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Stay ahead of changing regulations.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO monitoring strategy.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.