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Quick reference guide - global medical device UDI requirements and timelines

Bethaney Lentz

February 10, 2025

4 min read

This article was last updated on February 10, 2025.

What is UDI?

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 timelines and deadlines vary by market, classification risk, 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 (draft or implemented) and is current as of the date of this article.

*Note: these dates can change as participating countries adjust their plans. We do our best to update this as more information becomes available.
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‍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).

Australia UDI requirements

Australian UDIGuidelines
Reporting Database: AusUDID (pre-production)

The Australian government for medical devices, the TGA, has not launched any official regulations or timeline for mandatory UDI labeling. They do provide a wealth of information on their website that is worth reviewing. In the meantime, however, they are hoping for a Q1 2025 implementation. The AusUDID Pre-Production environment is available for sponsors and manufacturers of medical devices supplied in Australia. It is a test environment that allows testing of data submission, prior to submission to the AusUDID Production environment. Any sponsor or manufacturer with an active TBS account can access the database.

Brazil UDI requirements

ANVISA UDI guidelines
Reporting database:TBD

RDC No. 591/2021 is the regulations guideline for the identification of medical devices regulated by ANVISA, implementing the Unique Identification of Medical Devices (UDI) system. In July 2024, ANVISA finalized amendment RDC No. 884/2024 which implemented various adjustments to RDC 591/2021. The biggest take-away regarding UDI is the extension of one year on the implementation deadlines.

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

Canada UDI requirements

Health Canada website
Reporting Database: N/A
Position paper on the current state of UDI implementation
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Medtech Canada strongly supports the global initiative led by regulators under the guidance of the International Medical Devices Regulators Forum (IMDRF), which aims to standardize the identification of medical devices by requiring that certain medical devices carry an internationally recognized UDI. Currently, there is no process in place for UDI in Canada.

China UDI requirements

China (NMPA) website
Reporting Database: China National UDI Database
Announcement No 22 of 2023

On January 1, 2021, the NMPA implemented the UDI system for its first batch of medical devices, including 69 Class III devices. The following year, June 1, 2022, followed the implementation for the second batch of other Class III medical devices (including IVD reagents). Then in 2023, Order No. 22 announced the third batch of products to adopt the UDI system.

As of June 1, 2024, medical devices listed in the third batch implementation product catalog must have already had UDI implemented. According to the degree of risk and regulatory needs, some Class II medical devices in the third batch included high-demand single-use products, items selected for centralized procurement, and medical aesthetic products, totaling 103 types in 15 categories.

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

European Union UDI Information
Reporting Database: EUDAMED
Rimsys Updated EUDAMED Timeline Blog Post

The UDI & Devices module is expected to be declared fully functional by the end of Q2 2025 and mandatory for industry use on January 1, 2026. The EU continues to strongly recommend to the industry to establish its solution and to submit data on a voluntary basis.

European compliance timeline
Device risk class	Compliance date
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

Medical Devices Rules, 2017
Legal Metrology Act, 2009

Reporting Database: N/A

Rule 46 of Medical Device Rule 2017 was set to require UDI labeling by January 1, 2022. However, details on how the UDI needs to be implemented have not yet been released but India's labeling and traceability requirements must be met as per CDSCO regulations.

In addition to the Medical Device Rule 2017, the Legal Metrology Act, 2009 focuses on standardizing weights and measures and ensures that packaged commodities, including medical devices, are labeled with accurate and clear information.

Japan UDI requirements

Law to Ensure Quality, Efficacy and Safety of Pharmaceuticals, Medical Device, and Similar Products

Reporting Database: N/A

There are two regulatory authorities responsible for regulation of medical devices in Japan: The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). The MHLW is responsible for the administrative actions such as guidance and approval, and judgment on whether or not a product is considered a medical device. The PMDA undertakes product review and post-market safety measures.

As of Dec 2022, bar code labeling based on international standards is required for immediate containers/wrappings/retail packages of medical devices. It is expected for barcodes to be displayed on every medical device in unit of use for patients. Japan was an early promoter of standardized barcodes and is still working towards harmonizing the requirements with global UDI expectations.

The Pharmaceuticals and Medical Devices Act (PMD Act) translates in Japanese meaning "Law to Ensure Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, and Similar Products," but is often shortened to Act on Pharmaceuticals and Medical Devices or just PMD Act.

Saudi Arabia UDI requirements

Requirements for Unique Device Identification (UDI for Medical Devices)
Reporting Database: Saudi-DI

The SFDA requires compliance with the Unique Device Identification (UDI) regulations on all medical device companies in Saudi Arabia for all classifications. Medical device classifications include: devices, IVD, non-medical IVD, chemical for medical use, distillation device, general lab use, HCT/Ps product and radiation devices.

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, 2024

Singapore UDI requirements

Guidance for UDI Implementation
Reporting Databases: Singapore Medical Device Register (SMDR) - For risk class B or higher, Class A Medical Device Database - Risk class A only

Singapore is now requiring compliance with UDI labeling and database registration. They will accept UDI labels for devices already marketed in the U.S. and the EU without any need for modification. However, if they are not marketed in either country, then they are required to implement via Singapore UDI regulations.

Companies are given an additional 6 months from the compliance date to deplete the respective medical devices that have been imported prior to the compliance date and exist in their current supply chain.

Note:

• UDIs will not be required for medical devices for clinical research, investigational testing or clinical trial and custom-made medical devices

• Medical devices authorized for supply via Special Access Routes (GN26, GN27, GN29) are required to comply with UDI requirement on a risk-calibrated approach

Singapore compliance timeline
Device risk class	Compliance dates (labeling and registration)
High-risk implantable	Nov 2022
Class D, General medical devices and IVDs	Nov 1, 2024
Class C, General medical devices and IVDs	Nov 1, 2026
Class B, General medical devices and IVDs	Nov 1, 2028
Class A, General medical devices and IVDs	Not required, voluntary

South Korea UDI requirements

Act on In Vitro Diagnostic Medical Devices
Act on Medical Devices
Reporting Database: South Korean Integrated Medical Device Information System (IMDIS)

South Korea has already implemented UDI regulations by Article 20-23 of the Medical Device Act (No. 14330) and Article 54-2 of Enforcement Regulations of Medical Device Act (No. 1512).

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

Guidance document from Taiwan FDA
Reporting Database: TUDID

Taiwan has previously implemented UDI regulations, which include labeling and database reporting requirements.

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

United States UDI requirements

FDA website for UDI
Reporting database: GUDID database

The United States has previously implemented UDI regulations, which includes labeling and database reporting 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

* 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 simply 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

Looking for more information? You can visit our EUDAMED resource center, where you will find videos and resources to help you plan for UDI requirements in Europe. In addition, you may enjoy our blog post that outlines our views on the recent EUDAMED timeline updates.

For a broader introduction to UDI, see our Rimsys UDI Overview blog post.

If you're looking for an automated, integrated solution to help you meet changing regulations and manage your global UDI program, request a custom Rimsys demo!

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Registration deadlines don't have to be a risk. See how centralized data, automated alerts, and standardized workflows keep global registrations on track

How to Prevent Registration Deadline Misses in 2026

Bethaney Lentz

August 4, 2026

4 min read

A missed registration deadline can halt sales, trigger regulatory penalties, and damage your organization's credibility with health authorities. For MedTech regulatory affairs teams managing hundreds or thousands of product registrations across dozens of markets, preventing deadline misses requires more than calendar reminders. It demands structured data, clear workflows, and real-time visibility into expiration timelines.

This guide explains why registration compliance deadlines are missed and how your team can prevent delays through stronger data control, workflow visibility, and process standardization.

Key Takeaways: How to Prevent Registration Deadline Misses in 2026

Registration deadline misses typically stem from fragmented data, unclear ownership, and siloed communication between teams.

Proactive renewal management requires real-time visibility into expiration dates across your entire global product portfolio.

Standardized workflows with assigned accountability eliminate the confusion that leads to overlooked deadlines.

Rimsys centralizes registration data and automates renewal alerts, reducing the risk of missed deadlines by up to 90%.

Investing in a purpose-built RIM platform protects revenue continuity and maintains uninterrupted market access.

Why Do MedTech Teams Miss Registration Compliance Deadlines?

Registration deadline misses occur because the operating model cannot scale with growing portfolio complexity. Understanding root causes is the first step toward prevention.

Fragmented Data Across Systems and Regions

Many organizations track registrations using disconnected regional trackers, shared drives, and individual team member records. When product data lives in multiple locations, no single source of truth exists. This fragmentation makes it difficult to identify upcoming expirations before they become urgent.

A registration that expires in Brazil may be tracked in one system while the same product's EU approval is monitored elsewhere. Without connection between these records, teams lack portfolio-wide visibility into renewal timelines.

Unclear Ownership and Accountability

When responsibilities are distributed across regional leads, in-country partners, and distributors without clear accountability structures, deadlines fall through the cracks. Team members may assume someone else is handling a renewal, leading to inaction until the deadline passes.

Organizations with high turnover face additional risk. When key personnel leave, institutional knowledge about pending renewals often leaves with them.

Reactive Tracking Instead of Proactive Management

Calendar-based reminders and email notifications are inherently reactive. By the time a reminder appears, teams may not have enough runway to gather required documentation, coordinate with authorities, or address unexpected complications.

Effective deadline management requires proactive monitoring that surfaces upcoming expirations months in advance, not days before they occur.

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What Happens When Registration Deadlines Are Missed?

The consequences of missed registration deadlines extend beyond administrative inconvenience. They create tangible business disruptions that affect revenue, reputation, and regulatory standing.

Loss of Market Access and Revenue Disruption

An expired registration means your product cannot legally be sold in that market. Regulatory teams must halt shipments, distribution partners cannot fulfill orders, and revenue stops flowing. For high-volume products or critical markets, even brief interruptions to the supply chain can translate to significant financial impact.

Re-registering a lapsed product often takes longer than a standard renewal. Your team may face additional scrutiny, updated documentation requirements, or queue delays that extend the time to market restoration.

Regulatory Penalties and Increased Scrutiny

Health authorities track compliance history. Missed deadlines signal operational weaknesses that can trigger increased inspection frequency, additional documentation requests, or enhanced scrutiny on future submissions. Building trust with regulators takes years; eroding it takes one avoidable miss.

Damage to Distributor and Partner Relationships

In-country partners and distributors depend on your organization to maintain valid registrations. When market access lapses, partners bear the burden of explaining delays to healthcare providers and end customers. Repeated misses can damage long-term business relationships and competitive positioning.

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How to Identify Products at Risk of Deadline Misses

Prevention starts with identifying which registrations are most vulnerable. A systematic risk assessment helps teams prioritize attention and allocate resources effectively.

Create a Consolidated Registration Inventory

Bring all registration data into a single view. Include product identifiers, registration numbers, approval dates, expiration dates, responsible parties, and market-specific requirements. This inventory becomes your foundation for risk assessment.

Rimsys Registration Software centralizes this data automatically, linking registrations to products, submissions, and regulatory intelligence in one structured system.

Segment by Expiration Timeline and Complexity

Not all renewals carry equal risk. Categorize registrations by time remaining until expiration and by the complexity of renewal requirements. Products expiring within the next 90 days with extensive documentation needs should receive immediate attention.

Consider country-specific factors. Some markets require local testing, updated clinical data, or notified body involvement. These requirements extend lead times and increase the risk of delays.

Assess Documentation Readiness

For each at-risk registration, evaluate whether required documentation is current and accessible. Outdated technical files, missing test reports, or incomplete labeling information create bottlenecks that delay renewal submissions.

Documentation gaps discovered weeks before a deadline often cannot be addressed in time. Early assessment ensures enough runway to resolve issues.

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Building a Proactive Renewal Management System

Moving from reactive tracking to proactive management requires intentional process design. The following components form the foundation of an effective renewal management system.

Establish Clear Ownership for Every Registration

Assign a single accountable owner for each registration. This person is responsible for monitoring expiration timelines, coordinating renewal activities, and escalating issues that require additional support.

Ownership should be documented within your registration management system, not stored in separate organizational charts or email threads. When someone leaves the organization, ownership transfer becomes straightforward.

Define Standard Lead Times by Market and Product Type

Different markets have different renewal timelines. EU MDR renewals involve notified body coordination. FDA establishment registrations follow annual cycles. ANVISA submissions may require specific local documentation.

Document the standard lead time needed for each market and product type. Use these lead times to trigger renewal workflows well before deadlines approach.

Implement Automated Expiration Monitoring

Replace manual calendar tracking with automated monitoring that surfaces upcoming expirations across your entire portfolio. Alerts should trigger at multiple intervals, such as 180 days, 90 days, 60 days, and 30 days before expiration.

Automated monitoring ensures that no registration is overlooked, regardless of portfolio size or team bandwidth. Rimsys Global Regulatory Compliance capabilities include lifecycle tracking and automated alerts that reduce missed renewal risk.

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Standardizing Workflows to Prevent Oversight

Consistent workflows eliminate the variability that leads to deadlines. When every renewal follows the same structured process, teams can identify and address deviations before they cause problems.

Create Renewal Workflow Templates

Define the steps required for each type of renewal. Include documentation gathering, internal review, submission preparation, authority submission, and post-submission tracking. Assign responsible parties and expected durations for each step.

Templates ensure that new team members can execute renewals correctly without relying on undocumented institutional knowledge.

Build Escalation Paths for Delayed Activities

Not every renewal proceeds according to plan. Documentation may be delayed. Authority responses may take longer than expected. Partners may fail to submit required local information.

Define clear escalation paths that activate when activities fall behind schedule. Escalation should be automatic and visible, not dependent on individual team members raising concerns manually.

Conduct Regular Pipeline Reviews

Schedule recurring reviews of your renewal pipeline. During these reviews, examine registrations approaching expiration, identify any blocked activities, and confirm that responsible parties are on track.

Pipeline reviews surface potential issues early, when corrective action is still possible. They also reinforce accountability by making renewal status visible to leadership.

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How Data Control Reduces Deadline Risk

Strong data control is the foundation of reliable deadline management. When registration data is accurate, current, and accessible, teams make better decisions and avoid preventable misses.

Maintain a Single Source of Truth

Eliminate competing data sources by establishing one authoritative system for registration information. All team members, partners, and stakeholders should access the same data, ensuring consistency and reducing confusion.

A single source of truth means that when someone asks about a product's registration status in a specific market, the answer is immediate and reliable. No cross-referencing multiple trackers. No waiting for colleagues to respond to email inquiries.

Connect Registration Data to Product and Submission Records

Registrations do not exist in isolation. They connect to specific products, rely on previous submissions, and may be affected by regulatory changes or product modifications. Systems that link these data types enable more accurate impact analysis.

When a product design change occurs, connected data helps teams identify which registrations may need updated. When regulations evolve, linked intelligence shows which markets and products are affected.

Ensure Version Control and Audit Readiness

Regulatory authorities expect organizations to demonstrate controlled processes. Maintain version history for all registration-related documentation. Track who made changes, when changes occurred, and what was modified.

Audit readiness built into daily operations means less scrambling when inspections occur. It also shows the historical context needed to understand how registration status evolved over time.

Leveraging Technology for Visibility and Automation ‍

Technology plays a critical role in scaling deadline management across large portfolios. Purpose-built regulatory information management platforms offer capabilities that generic tools cannot match.

Dashboard Visibility Across Global Markets

Executive and operational dashboards display at-a-glance visibility into registration status across your entire portfolio. Filter by market, product line, expiration timeline, or responsible party, to focus on relevant subsets.

Dashboard visibility enables leadership to ask and answer questions quickly:

How many registrations will expire in the next quarter?

Which markets have the highest concentration of upcoming renewals?

Are any renewals currently blocked?

Automated Alerts and Notifications

Configure alerts that notify responsible parties when action is required. Notifications should be specific, actionable, and timely. Rather than generic reminders, alerts should identify the specific registration, required action, and deadline.

Effective notification systems reduce the cognitive burden on team members. Instead of tracking deadlines mentally, they receive prompts when attention is needed.

Reporting for Continuous Improvement

Track metrics that indicate process health. Monitor the number of registrations renewed on time, average lead time utilization, and frequency of expedited renewals. Use these metrics to identify process weaknesses and drive improvement.

Organizations that measure renewal performance can demonstrate compliance maturity to regulators, partners, and investors. Metrics also help justify investments in process improvement.

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How Rimsys Helps Prevent Registration Deadline Misses

Rimsys is the first and only holistic Regulatory Information Management software purpose-built for MedTech. It centralizes registrations, submissions, regulatory intelligence, and UDI data in one connected platform, giving teams the visibility and automation needed to prevent deadline misses.

Centralized Global Registration Tracking

Rimsys maintains a structured, product-centric data model that connects registrations to products, markets, and submissions. Teams gain real-time visibility into where every product can be sold, which registrations are pending, and which are approaching expiration.

Six of the world's top 12 MedTech manufacturers trust Rimsys to manage global regulatory operations, achieving up to 90% reduction in reporting effort and elimination of manual tracking risk.

Automated Lifecycle Alerts

Rimsys monitors registration lifecycles and automatically alerts teams to upcoming expirations, renewals, and information requests. Automated alerts ensure that no registration is overlooked, regardless of the portfolio size.

With Rimsys AI, teams can accelerate regulatory work through AI-assisted workflows that reduce repetitive tasks while keeping human judgment in control.

Connected Regulatory Intelligence

Registration deadlines do not exist in isolation from regulatory change. New requirements can affect renewal timelines, documentation needs, or market access conditions.

Rimsys connects registration data to regulatory intelligence and impact assessment workflows, helping teams understand how changes affect their portfolio before deadlines become urgent.

Creating a Culture of Deadline Accountability

Technology and process alone do not prevent deadline misses. Organizations must also cultivate a culture where deadline accountability is valued and reinforced.

Make Renewal Performance Visible

Share renewal metrics with teams and leadership regularly. Celebrate on-time renewals and analyze near-misses to identify improvement opportunities. Visibility creates accountability without requiring punitive measures.

Invest in Team Training and Development

Ensure that team members understand the importance of deadline management and have the skills to execute renewal workflows effectively. Training should cover both procedural requirements and the business impact of missed deadlines.

Support Cross-Functional Collaboration

Registrations often require input from quality, engineering, labeling, and commercial teams. Foster collaboration across functions to ensure that dependencies are identified early and addressed proactively.

When regulatory affairs teams operate in silos, they lack the information needed to anticipate complications. Cross-functional visibility enables earlier intervention.

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In Conclusion: How to Prevent Registration Deadline Misses

Preventing registration deadline misses requires intentional effort across three dimensions: data control, workflow visibility, and process standardization. Organizations that invest in these areas protect revenue continuity, maintain regulatory standing, and preserve partner relationships.

The complexity of global regulatory operations is not slowing down. As portfolios expand and requirements evolve, teams need infrastructure that scales. Rimsys transforms regulatory operations from administrative tracking into strategic enablement, bringing speed, visibility, and confidence to global expansion.

Ready to eliminate deadline risk from your registration management? Speak with the Rimsys team to see how leading MedTech manufacturers manage global registrations with precision and control.

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References:

How to Register and List a Medical Device with the U.S. FDA

Medical Devices and EUDAMED in Europe

U.S. FDA, Code of Federal Regulations, Title 21, Subchapter H, Part 807

IMDRF (International Medical Device Regulators Forum)

ISO 13485, Medical Devices

How Smith & Nephew Repositioned Regulatory as a Strategic Commercial Partner

Caroline La

May 28, 2026

4 min read

Smith & Nephew is a global medical device manufacturerwith a broad portfolio spanning orthopedics, sports medicine, and woundmanagement, sold and registered across markets worldwide. Before Rimsys,regulatory data was scattered across spreadsheets, shared drives, anddisconnected systems.

When Smith & Nephew selected Rimsys, they deployed enterprise-wide from day one. Executive reporting moved from manual fire drills to real-time dashboards. Change impact assessments became faster and more consistent. The regulatory team made the shift from reactive compliance function to strategic partner to the business.

The Challenge

Regulatory data at Smith & Nephew lived in multiplespreadsheets, shared drives, SharePoint sites, emails, and disconnectedsystems. Without a centralized record, the team could not reliably trackregistration timelines, measure on-time submissions, assess change impacts, orunderstand the downstream impact of product changes across markets. Preparingexecutive reporting meant manually assembling data from multiple sources, aprocess that consumed time and introduced risk each time.

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The Solution

Smith & Nephew selected Rimsys for its configurable, notcustomized, platform: an intuitive user interface, centralized submissionmanagement, robust metrics, change assessment capabilities, and UDI supportwith machine-to-machine transmission. Rimsys’ interconnected modulearchitecture linked products, registrations, projects, change assessments, andUDI in a centralized location.

Rather than piloting in one business unit, Smith &Nephew deployed Rimsys across the entire regulatory organization from day one.The decision was deliberate: a partial deployment would have preserved thefragmentation. Enterprise-wide adoption established consistent metrics,standardized processes, and a single source of truth from the start.

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The Results

Executive and board reporting, previously built from manualdata pulls, now flows directly from Rimsys in real time. What had been adisruptive, recurring effort is now a routine view. Leadership has thevisibility to make faster, more confident decisions, and the regulatory team isno longer pulled into reporting fire drills.

Change management has also been transformed. Direct linkagebetween products, registrations, and projects means impact assessments arefaster and less dependent on individual knowledge. UDI operations havesimilarly improved: machine-to-machine transmission has reduced manual uploadsand centralized DI record visibility supports global UDI requirements.

The most significant shift is strategic. With centralizedregulatory intelligence and real-time data, Smith & Nephew’s regulatoryteam now actively supports commercial planning: informing budget cycles,guiding renewal and launch sequencing, and advising on regulatory pathways toaccelerate market entry. Regulatory is no longer a downstream compliancefunction. It is a business partner.

Smith & Nephew now runs four modules across its RIM operation:

Registrations— Centralized license tracking across 250 countries and 30+ business units
Change Assessments— Direct product-registration linkage for faster, consistent impact assessments
Executive Reports— Real-time dashboards replacing manual data pulls and board reporting fire drills
UDI— Machine-to-machine transmission reducing manual uploads across global markets

Take this to your team

If you’re evaluating how to modernize RIM operations at scale, the Smith & Nephew case study is a practical reference to share internally. It covers the full implementation story, module breakdown, and results data in a format built for stakeholder conversations.

Download the Case Study

How Philips Scaled Active Product Registrations More Than 20x

Caroline La

May 21, 2026

4 min read

Philips Healthcare operates one of the largest regulatory portfolios in global MedTech: products registered across 250 countries, with a footprint that grows with every acquisition. Before Rimsys, that complexity was managed through email and spreadsheets. Submission packages moved through inboxes with no audit trail, no performance data, and no reliable view of where products were authorized to ship.

Philips selected Rimsys in 2022 as the enterprise RIM platform to bring regulatory order to that complexity. Since go-live, active product registrations have scaled more than 20x, user adoption has doubled in the last six months, and the regulatory affairs function now operates from a single source of truth spanning the entire enterprise.