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Learn why UDI is relevant to regulatory affairs and how Rimsys can help medtech RA teams manage the growing complexities associated with UDI data.

Bethaney Lentz

March 11, 2024

4 min read

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:

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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.

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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 June 2024, an amendment to the regulation was published in RDC 884/2024. The updated timelines are published for each risk classes II, III, and IV below. The amendment had no impact on the timeline for class I devices.

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

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Brazil compliance timeline
Device risk class	Compliance dates (labeling)
Class IV	Jul 2025
Class III	Jan 2026
Class II	Jan 2027
Class I	Jan 2028

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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
South Korea	IMDIS UDID	40	GS1, HIBCC, ICCBBA
Taiwan	TUDID	23	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.

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Rimsys Announces Rimsys AI to Eliminate Repetitive Tasks and Enhance Decision-Making for MedTech Regulatory Teams

Rimsys, the leading Regulatory Information Management (RIM) platform for the MedTech industry, today announced the launch of Rimsys AI, a suite of embedded artificial intelligence (AI) agents.

Defining nonconformance

Very simply, a nonconformance occurs when a specification is not met. The FDA defines a specification in 21 CFR 820.3 as “any requirement with which a product, process, service, or other activity must conform,” and ISO 13485:2016 as a “need or expectation that is stated, generally implied, or obligatory.”

While managing nonconformance starts with fully defining specifications; it is the identification, tracking, and resolution of nonconformance that is a focus of medtech quality and regulatory teams and a requirement of both ISO 13485:2016 and the FDA’s 21 CFR Part 820 quality system regulation.

Identifying nonconformance occurrences

As part of a compliant quality system, medical device manufacturers should implement procedures to identify and address both major and minor non-conformances. Nonconformances may be identified through processes found in multiple subsystems that are part of an overall quality management system within the organization.

The systems and subsystems in which nonconformances are identified typically include:

ERP
Regulatory information management (RIM)
Product lifecycle management (PLM)
Document management
Customer service / customer management
Complaint handling
Device history records
Audit management
CAPA
Training/learning management
Calibration/preventative maintenance
Development change management

Evaluating nonconformance

Once a nonconformance is identified, it should be evaluated in a timely manner, and a determination made as to the disposition of any affected products. Requirements for additional investigation and reporting should also be identified. Based on the severity of the nonconformance and its effect on the safety and efficacy of devices being manufactured or already in the market, a CAPA (corrective/preventative action) record may need to be created. In the U.S., this is defined in the quality regulation 21 CFR Part 820.100.

To disposition a nonconformance, consider the following:

Will the existing system detect the nonconformance if it recurs in time for remediation?
How likely is it that this issue will recur?
What is the impact of the non-conformance (i.e., could it affect patient health)?

Issues that are more severe or are more likely to recur should trigger a more immediate and comprehensive response.

Nonconformances that are escalated and handled under CAPA are based on risk and can include those that have or could have an impact on a product or process that is:

Not easily corrected
Recurring
Severe

In addition, nonconformances that rise to the level of a CAPA require significant resources and typically result in a full project to identify root cause(s), containment, and corrective actions, and monitoring for effectiveness.

Nonconformances that don’t require a CAPA have simpler resolutions that include documenting actions taken to correct the issue (or justification for no action). If the issue is not recurring, there may be no other action required. For example, a nonconforming material received from a vendor may be a singular issue that was easily identified through existing inspection procedures and is not expected to recur. In this case, the material is returned to the vendor and no additional action is required.

Processes that are out of conformance are often resolved through improved documentation and/or additional user training. However, be sure that the true root cause of the nonconformance is identified as procedural nonconformances can signal additional issues.

Documenting nonconformances

An important part of nonconformance procedures is the nonconformance report (NCR) or other documentation procedures. Nonconformances are typically documented within the subsystem in which they were identified. Some organizations will have a nonconforming system in which issues originating from all subsystems are documented. Centralized nonconformance systems allow for trending and other analysis across all subsystems, the results of which may generate CAPAs.

The requirements for documenting a nonconformance may vary by subsystem. In general, however, nonconformance documentation records:

The requirement/specification that was not met.
The objective evidence supporting the determination.
The action that is being taken to address the nonconformity.

Nonconformances are a common point of focus during quality audits by regulatory bodies, including the FDA, and should follow a well-documented process. Auditors will often try to determine if the quality system is functioning effectively by looking at self-identified nonconformances and comparing them to externally reported nonconformances. This is to ensure that nonconforming products were not released, or that the appropriate actions were taken to resolve issues in the field.

The importance of nonconformance reports

Nonconformances related to distributed products of higher risk result in nonconformance reports issued to government authorities through vigilance reporting, medical device reporting, and field action/recall reports. For example, the FDA requires that a medical device report be submitted within 30 days of a serious adverse event (see 21 CFR Part 803 Subpart E). Strong reporting procedures for nonconformances of all types are important in identifying trends, addressing issues before they become critical, and as part of a complete quality management system.

A nonconformance reporting procedure is only part of a strong quality system. Read An overview of 21 CFR part 820 and ISO 13485 overview for more information on establishing quality systems for medtech companies.

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Why we developed Rimsys from the ground up

Wendy Levine

May 26, 2022

4 min read

Rimsys has had quite a year already! In early December, we closed on $16 million in Series A financing and since then we have been carefully growing the company to better serve our customers and the regulatory affairs community. We have almost doubled our employee count and redesigned the Rimsys system to deliver deeper functionality that is even easier to use. We had our first in-person employee meeting here in Pittsburgh at the end of April where we introduced our new mission statement, and we are all excited to be doing our part to improve global health!

All of these changes made us think back to the founding of Rimsys and how far we have come. So - I sat down with Rimsys Founder and CEO, James Gianoutsos, to talk about the genesis of the company and how he knew that a new type of system designed for medtech regulatory affairs professionals was needed, and needed to be built from the ground up.

Q: What was the biggest challenge you faced as a regulatory professional that led you to form Rimsys?

James: The biggest challenge I saw while working at Philips for many years was completely understanding the complexity and the nuances around everything regulatory from a product standpoint. This really came to light whenever we acquired products. Just seeing firsthand how inefficient and out of compliance these manufacturers really were, and how hard it was from an administrative standpoint just to get into compliance and then to stay compliant, was striking.

I was working with a smaller medical device company which had acquired products from Philips. Philips provided the company with a list (a color-coded Excel spreadsheet) of all of their products that the company had acquired along with the registration status of those products globally. After digging into the spreadsheet for several months, we found that about 50% of it was wrong, incomplete, or just completely missing. The company was trying to keep track of registration information, but the available tools were making it nearly impossible. I realized that this was the challenge, and that there really wasn’t a solution on the market that could solve that problem in an easy manner and in a medtech regulatory-focused way.

‍Q: There were solutions on the market that were geared more towards the pharmaceutical industry, correct?

‍James: Yes. So I did what every other regulatory professional did, which was to Google “regulatory software,” and I saw that there just really wasn’t anything on the market that fit our needs. The solutions on the market really were pharma-specific, even those that said they worked with medical devices. The workflows and regulatory requirements for medtech are very specific for each market, depending on the product type and risk class and so many other factors. To use a pharma system that was already on the market just wasn’t even an option because it was like comparing apples to oranges. It is completely different from the regulatory and workflow side of things.

‍Q: There are existing tools used by the regulatory community, such as quality management and document management systems. Did you envision the new RIM system integrating with existing tools, replacing them, or a little of both?

‍James: I never set out to replace those types of systems, no. In fact, I knew that existing system architecture and infrastructure couldn’t handle the specific medtech regulatory workflows but needed to connect to those systems. There have always been PLM (Product Lifecycle Management) systems that contain a company’s product master data, but those systems were never meant to be workflow-driven based on regulatory requirements. At the same time, they are critical for organizing and maintaining product-specific metadata. Then there are ERP systems, which are really about making sure companies have sales flags (i.e. regulatory blocks) in place, appropriate shipping codes, or selling status linked to product registration status. Regulatory professionals are concerned about answering two questions for ERP users; one, “does the product have a valid and current registration within the country or market,” and two, “if it is registered, are we selling and shipping into that market.” Lastly, quality/document management systems house critical documentation and records needed for registrations. The problem with these systems is that there are no regulatory workflows and no way to compile technical documentation, leaving the documents and records siloed from the regulatory filings.

To do the things that a regulatory affairs professional, in a critical regulatory department, does for their company, the system really had to be built from the ground up with all of these systems in mind. It had to be product-centric. It had to integrate with all these other sources of information, because there really wasn’t a common connection point between your products, your documentation, and the records that you needed to compile and how that relates to getting products on the market. We had no way to communicate to our other systems that a product is actually available for sale in that market or that it confidently can, or more importantly cannot, ship to that market.

‍Q: What was the most difficult piece of functionality to implement in Rimsys?

James: Well, at the time it kind of all seemed difficult! No, really the most difficult part was thinking thoughtfully and strategically about how data was going to be mapped and used in conjunction with other data elements, in order to make the system most helpful from a user perspective. We wanted to single-source information to enhance and streamline regulatory workflows, but then also make sure that it was as user friendly as possible. There are a lot of stakeholders that need information or have input into regulatory workflows. Quality assurance, marketing operations, R&D, engineering, sales - all of those specific stakeholders need to view information in a way that is understandable to them.

We worked hard to bring all that information, streamline complex regulatory workflows, and all of those internal and external data sources together in an understandable and user-friendly way.

Q: How important has the technology itself been in the creation of Rimsys?

James: Technology has been a huge advantage for us from day one. Our team had quality and regulatory backgrounds, so we knew what companies would expect from us. We knew we had to be 21 CFR Part 11 compliant. We knew we had to be ISO 27001 certified. We knew we had to have SOC2 Type 2 reports. We knew we had to integrate with a company’s existing IT infrastructure. We really had to build this thing from the ground up on a GxP compliant platform that we could build upon and expand, without having to go back and reinvent the wheel every time we added new functionality.

It’s continued to pay dividends for us because it was something that we thought about from the beginning and that gave us a lot of flexibility. We already had the system and infrastructure in place that we could then expand upon a lot more quickly than we would have been able to otherwise. It’s like the difference between building a house today and trying to remodel a house that was built in the year 1900. If you break down a wall in the older house, there might be so many hidden issues behind that wall - load bearing issues, knob and tube wiring, asbestos, etc. With new modern infrastructure, it is just night and day in terms of adapting quickly with changing regulations and a fast-paced market.

Q: Was there any specific technology you can talk about that became important to the development of Rimsys?

James: Our choice of technology was driven by our desire to build a system that was user friendly and built on a modern infrastructure that felt familiar to our users. So, we took a lot of the Google framework to build an application that didn’t look like enterprise software, but looked and felt more like a consumer product that is inviting, not overwhelming.

The other thing is that we built the system from day one to integrate because we knew we had to connect with a lot of different sources of information. We strategically built the system with API’s in mind.

Q: What is Rimsys doing differently than other software companies in the regulatory space?

James: We are creating a holistic solution, which is different from what is out there now. We know that registration management is just one key aspect of what regulatory affairs teams need. In order to create a proper regulatory system, we had to take into account all of the data and dependencies and build a system specifically for medtech regulatory teams and other key consumers of regulatory data. There has to be a single source of truth for this data, because otherwise it becomes a nightmare at the end of the day. Existing software solutions were siloed and purpose-built for other industry needs, such as eQMS, PLM and ERP. None of those systems can do what a holistic RIM platform can do. Because of the complex workflows, the regulatory needs are far too broad and interdependent, that data infrastructure is completely different, data sources are too numerous, and the systems offer limited support to bring everyone and everything together into a cohesive, streamlined, compliant and medtech-specific solution.

Another key component of what we are doing is to institutionalize regulatory knowledge and resources into Rimsys—this is at the heart of who we are and what we do. Having the only purpose-built, holistic RIM platform built by and for regulatory professionals specific for the medtech industry really couldn’t be done without internalizing that experience within our own team.

Q: What are you most proud of when it comes to Rimsys?

James: I think there are two things that immediately come to mind. Having our Rimsys 5 platform launch is really exciting. This is the fifth iteration of our platform, and we did it by listening to our customers and iterating over and over again to get it right. We had to go back to the drawing board a couple of times, not because what we had written wasn’t working, but because our customers that were using the system every day gave us better ways to do things. Rimsys 5 is a really proud moment because this is the platform that we are taking into the future, that will let us get to the next level where we are truly empowering regulatory professionals to make critical decisions and do the job that they are meant to do.

The ability for us to listen to our customers, take that feedback and move fast is the second thing I’d mention here. We know that this has to be a validated system, but we are able to make changes and add features in a way that is thoughtful and gets our customers what they need right away. Regulatory professionals are very particular. I know since I am one, and making sure they are comfortable using Rimsys from day 1 is critically important. Being a customer-centric company really makes our experience as a team extremely rewarding.

Q: Where is Rimsys going next? What are you most excited about?

I think I am most excited about Rimsys being an advocate for the medtech regulatory community and helping them wherever we can. Regulatory has a seat at the table now and it is a great feeling to see that we’re able to help these companies to streamline their workflows, accelerate time to delivery for life-saving products and maintain that compliance to keep those products on the market. Regulatory affairs is a mission critical department that the medtech industry cannot underestimate. It’s empowering because while we are helping our customers, they are helping us and every single one of our other customers through the journey of regulatory uncertainty that everyone is going through right now. It feels like a real partnership between us, our customers, and the industry as a whole and I am excited to see where that will take us.

I am also really excited about where we are going with regulatory intelligence. We are just scratching the surface of this now, but you will see regulatory intelligence data built into Rimsys and providing RA professionals with tools that can really provide a competitive advantage for their company. The release of Rimsys 5 platform (“Phase 1”) provides us that platform that will take us into “Phase 2” of Rimsys, with embedded intelligence that will further empower regulatory professionals to make decisive, correct and confident decisions for their products and their company.