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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.
An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)
This document is a summary of the regulation and does include wording taken directly from the regulation itself. The original regulation should be referenced directly, however, for complete information when submitting an IDE request.
What is an investigational device exemption?
An investigational device exemption (IDE) allows a device to be used in a clinical study prior to obtaining market approval to collect safety and effectiveness data. Clinical studies are typically required to support a Premarket Authorization (PMA), but a small percentage of 510(k) applications also require clinical data when a predicate device comparison is inappropriate for the submission.
Before a clinical study is initiated, an investigational device must have an approved IDE, unless it is exempt. Devices may be exempt from IDE requirements if they are noninvasive diagnostic devices, being used for consumer preference testing unrelated to device safety or efficacy, or intended solely for veterinary use or research with laboratory animals. Refer to the full text of 21 CFR 812 for details and additional exemptions.
Part 812 – General Provisions (Subpart A)
Scope
This regulation is applicable to all clinical investigations of devices used to determine safety and effectiveness, except where exempt.
Applicability
Abbreviated Requirements
Investigations are considered automatically approved for IDEs if the device is not considered a significant risk, unless the FDA has specifically notified the sponsor otherwise. In these cases, the sponsor must still obtain IRB approval for the investigation and must comply with other requirements of Part 812, including proper labeling, record keeping, and conformed consent requirements.
Exempted investigations
IDEs are not required for devices that fall into one of the following categories:
- Devices that were in commercial distribution prior to May 28, 1976 that were used or investigated according to requirements in effect at that time. Devices that were introduced after May 28, 1976 but which have been found to be substantially equivalent to devices introduced earlier may also be exempt. This exemption is limited for Class II and III devices from the date an FDA regulation or order calls for the submission of a PMA (in the case of an unapproved Class III device) or establishes a performance standard for a Class II device.
- Diagnostic devices for which the testing is noninvasive and without significant risk, and is not used as a diagnostic procedure without confirmation through another product or procedure.
- Devices undergoing consumer preference testing, or testing of a device modification or combination of already distributed devices, if the testing is not for purposes of determining safety or efficacy and does not put subjects at risk.
- Devices solely for veterinary use.
- Devices intended for research on or with laboratory animals.
- A custom device that is not being used to determine safety or efficacy for commercial distribution.
Definitions
21 CFR Part 812.3 provides definitions for many terms, some of which are listed here.
Institution: A person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans. For example, a hospital, retirement home, confinement facility, academic establishment, and device manufacturer. The term has the same meaning as “facility.”
Institutional Review Board (IRB): Any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and functioning in conformance with part 56. The term has the same meaning as “institutional review committee.”
Investigational device: A device, including a transitional device, that is the object of an investigation.
Investigator. An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
Monitor: When used as a noun, this term means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research organization. Monitor, when used as a verb, means to oversee an investigation.
Significant risk device means an investigational device that:
- Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
- Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
- Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
- Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Sponsor: A person who initiates, but who does not actually conduct the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.
Sponsor-investigator: An individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. The obligations of a sponsor-investigator under this part include those of an investigator and those of a sponsor.
Subject: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.
Labeling of investigational devices
An investigational device or its packaging requires a label with the following information:
- Name and place of business of the manufacturer, packer, or distributor (per 801.1).
- Quantity of contents.
- Statement: “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.”
- Any additional relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.
- If used for animal research, a statement of “CAUTION—Device for investigational use in laboratory animals or other tests that do not involve human subjects” must be on the label.
IDE Labeling cannot have any statement that is false or misleading and cannot represent the device as safe nor effective.
Prohibition of promotion and other practices
An investigational device is intended for use only within an investigation. Therefore, until a device is approved for commercial distribution by the FDA, the sponsor or investigator (or those working on their behalf) cannot:
To continue reading this Regulatory Brief, please download the full document here.
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Rimsys Becomes the Trusted Regulatory Partner for 6 of the Top 12 Global MedTech Manufacturers
“Adoption by half of the top global MedTech manufacturers is a powerful validation that we’re not just a solution, we’re setting the new gold standard for regulatory excellence.”
Pittsburgh, PA - August 7, 2025 - Rimsys, the leading Regulatory Information Management (RIM) software purpose-built for the MedTech industry, today announced a significant milestone: 6 of the world’s top 12 medical device manufacturers now rely on Rimsys to manage and streamline their global regulatory operations.
This milestone further solidifies Rimsys’ position as the trusted partner to the world’s most innovative and quality-focused MedTech companies.
Click here for the full list of the top 12 global MedTech companies.
“Today’s regulatory environment demands more than spreadsheets. Leading manufacturers recognize that regulatory operations are mission-critical, revenue-generating departments and need systems to match that level of importance,” said James Gianoutsos, Founder and CEO of Rimsys.
Rimsys’ unified, enterprise-grade RIM platform centralizes and automates critical regulatory processes—including market registrations, Unique Device Identification (UDI), essential principles/GSPR, and submissions management—reducing compliance risk and accelerating market access. Specifically tailored to the needs of medical device and diagnostics companies, Rimsys enables seamless collaboration across RA, QA, and commercial teams while delivering the audit-ready transparency global regulators demand.
“As more organizations embrace regulatory digital transformation, Rimsys is proud to lead the industry forward,” added Gianoutsos. “Adoption by half of the top global MedTech manufacturers is a powerful validation that we’re not just a solution, we’re setting the new gold standard for regulatory excellence.”
To learn more about the Rimsys, please visit www.rimsys.io.
About Rimsys
Rimsys is the leading provider of Regulatory Information Management (RIM) software purpose-built for MedTech manufacturers. The comprehensive platform digitizes and automates regulatory activities, helping MedTech regulatory affairs teams to efficiently achieve regulatory compliance and get products to market faster. Rimsys is designed around MedTech workflows and supports a full breadth of regulatory functions including registrations, submissions, UDI, EUDAMED compliance, essential principles, and standards management in a unified platform. Rimsys is trusted by half of the world’s top 12 MedTech companies to power their global regulatory operations. For more information, visit www.rimsys.io.
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Rimsys Announces Bulk UDI Submission and Rimsys Connect™ to Empower MedTech Regulatory Teams
New solutions deliver enterprise-grade data access and streamlined EUDAMED compliance, driving smarter, faster decisions across the business
Pittsburgh - April 29th, 2025 - Rimsys, the global leader in Regulatory Information Management (RIM) software for the MedTech industry, today announced two major enhancements to its platform: expanded Unique Device Identification (UDI) capabilities to support EUDAMED machine-to-machine (M2M) bulk transmission and Rimsys Connect™, a new enterprise Change Data Capture (CDC) solution that provides near real-time synchronization of Rimsys data with customers’ Business Intelligence (BI) solutions.
Together, these capabilities are designed to help MedTech organizations streamline compliance, reduce manual effort, and unlock the full strategic value of their regulatory data.
New UDI Capabilities Support EUDAMED Readiness
The UDI enhancements extend Rimsys’ industry-leading Universal UDI® framework, enabling MedTech teams to manage complex, global UDI programs in one unified RIM system. Key new capabilities include:
- Approving multiple records simultaneously via a simple, scalable workflow
- EU data governance support with all required attributes for EUDAMED transmission
- Bulk submission of records to both the GUDID and EUDAMED databases
These features allow teams to eliminate time-consuming, record-by-record processing, helping them meet the mandatory January 2026 EUDAMED compliance deadline with confidence.
“We’ve partnered closely with our customers to develop a UDI offering that meets increasing regulatory complexity and is easily scalable as new regulations come online,” said Adam Price, Director of Regulatory and Technical Programs at Rimsys. "We’re not only giving customers the ability to meet EUDAMED compliance but enabling them to manage their global UDI program in a single-sourced RIM solution for complete visibility.”
Introducing Rimsys Connect™: Enterprise Data Access, Redefined
Rimsys Connect™ offers enterprise customers a powerful new way to leverage regulatory data across the business. Built on a scalable, event-driven architecture, it provides secure, structured, near real-time streaming of Rimsys data into any modern data warehouse solution—such as Snowflake, Amazon S3, and Salesforce Bulk API 2.0.
“Rimsys Connect™ is not just a connector—it’s a strategic enabler,” said James Gianoutsos, Founder and CEO of Rimsys. “We’re giving regulatory affairs teams the ability to deliver insights that influence launches, accelerate tender responses, and align compliance with business impact. With Connect, RA teams become true strategic partners.”
By providing full access to customer data—registrations, UDI, projects, tasks, and custom attributes — Rimsys Connect™ supports a wide variety of enterprise use cases with customers’ own business intelligence solutions:
- Tracking on-time submission and decision KPIs
- Aligning registration timelines with product launch dates
- Conducting ROI analysis for renewals and market prioritization
- Accelerating tender readiness by combining RIM and PLM data
- Supporting post-market surveillance dashboards
While the initial release will focus on data access, Rimsys plans to expand Connect with curated BI templates and best practices to further accelerate enterprise customer time-to-value.
Solving the Data Fragmentation Problem for MedTech
Many regulatory affairs teams remain constrained by outdated tools, fragmented data sources, and increasing demands to deliver strategic insights to executive and commercial stakeholders. Rimsys Connect™ addresses these challenges by eliminating manual reporting workflows and enabling teams to analyze their regulatory data alongside financial, marketing, and quality systems.
“With Rimsys Connect™, regulatory teams can visualize and analyze their data in real time, assess launch readiness, and deliver more value to their organizations. This is how RA becomes a catalyst for better decisions—not just compliance,” said Gianoutsos.
Both Rimsys’ expanded UDI capabilities and Rimsys Connect™ will be available this summer. Those interested in learning more about these solutions and how they will enable greater automation, efficiency, and compliance can visit our booth at RAPS Euro Convergence May 13-15 in Brussels, Belgium, or sign up for Rimsys’ product update webinar on Thursday, May 22nd at 10 AM ET.
Read the press release here.
About Rimsys
Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping MedTech regulatory affairs teams to plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Rimsys is designed around MedTech workflows and supports a full breadth of regulatory activities including registrations, submissions, UDI, essential principles, and standards management in a unified platform. For more information, visit www.rimsys.io.
Contacts:
marketing@rimsys.io
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Rimsys Enters Strategic Alliance Relationship with KPMG
PITTSBURGH – March 11, 2025 -- Rimsys, the global leader of MedTech Regulatory Information Management (RIM) software, today announced that it has entered into a strategic alliance relationship with KPMG to advance digital transformation in the MedTech industry.
“KPMG’s deep experience in advisory and business transformation services and exceptional reputation make them a valuable alliance relationship for us,” said James Gianoutsos, Founder and CEO of Rimsys. “KPMG is on the cutting edge of industry trends and has a wide breadth of experience in helping companies innovate and scale. We are thrilled to work with them to help MedTech teams transform their regulatory management processes and leverage the benefits of automation and digitization as part of their broader transformation strategy.”
Founded for and by MedTech regulatory affairs professionals in 2017, Rimsys was created to bring efficiency to regulatory information management and fill an inhibitive technology gap in an underserved industry. Rimsys has since grown to support the world’s MedTech leaders backed by a staff that understands their complex workflows and a robust, secure technology infrastructure that allows customers to scale Rimsys software to support their changing regulatory needs and requirements.
“There is tremendous innovation happening in the MedTech industry, and we are excited to work with Rimsys to help clients transform how they manage regulatory information for getting new products to market and sustaining their existing product portfolios. It’s critical to approach these programs as a holistic business transformation across people, process, technology, data, and governance & controls,” said Dipan Karumsi, Principal, Consulting Sector Leader for Life Sciences at KPMG.
“Through our strategic alliance with KPMG, we can further expand our reach to large and enterprise MedTech companies and continue our exponential growth,” said James. “Combined with KPMG’s experience helping organizations mature their data collection and transformation processes to reach RIM readiness, we can enable the MedTech industry to innovate faster, strengthen compliance, and most importantly, improve the availability of life-changing medical technologies.”
See the full press release here.
FDA’s Final Rule on LDTs: What manufacturers need to know
In July 2024, the FDA's final rule in 21 CFR Part 809 on laboratory developed tests (LDTs) went into effect, amending its previous regulations to make it clear that IVDs, including those that are manufactured in laboratories, are classified as devices under the Federal Food, Drug, and Cosmetic Act. Our blog post provides an overview of LDTs, FDA’s final rule, the phase out policy schedule, and how LDT manufacturers can prepare themselves for compliance.
What are LDTs?
Simply put, LDTs are IVDs that are designed, manufactured, and utilized within a certified laboratory and are typically used for high-complexity testing.
Historically, FDA has used enforcement discretion only on LDTs, which means that most LDTs haven’t been subjected to specific regulatory requirements. However, the volume of and risks associated with LDTs have grown over the years. Some examples of modern LDTs include glucose tests, genetic tests for cancer and infectious diseases, and newborn screenings for early diagnostics. Without a regulatory framework in place, patients are at greater risk of receiving inaccurate test results, forgoing necessary or undergoing unnecessary treatment, and adhering to misleading or false product claims, possibly endangering patients and leading to higher healthcare costs.
FDA’s Final Rule on LDTs
Following the final rule that was issued, LDTs are now subject to the same regulatory requirements as other IVDs, including premarket reviews, quality system requirements, labeling requirements, adverse event reporting, and device listing and registration. To prevent disruptions in patient care, there is a four-year transition or phaseout period consisting of the following five stages:
- Stage 1 (May 6, 2025): LDT manufacturers will be expected to comply with FDA medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements for complaint files.
- Stage 2 (May 6, 2026): LDT manufacturers will be required to comply with IVD registration and listing requirements, labeling requirements, and investigational use requirements.
- Stage 3 (May 6, 2027): LDT manufacturers will need to comply with all other QS requirements not covered in Stage 1.
- Stage 4 (November 6, 2027): Unless a premarket submission is received before the start of this stage, LDT manufacturers of high-risk products will need to comply with premarket review requirements for IVDs that may be classified into class III or that meet the requirements of section 351 of the Public Health Service Act.
- Stage 5 (May 6, 2028): LDT manufacturers of moderate and low –risk products will need to comply with premarket review requirements for IVDs unless a submission is received before the beginning of this stage.
Manufacturers of LDTs that don’t meet the requirements in each stage are deemed non-compliant to the regulations governing IVDs and may be subject to FDA 483 observations or warning letters, financial penalties, and even worse, involuntary removal of products from the market.
Note that some LDTs will be exempt from these requirements. Refer to the FDA’s website for more guidance.
Preparing for Compliance
Despite a four-year phaseout period, it’s crucial for LDT manufacturers to start assembling a compliance plan. Starting as early as May 2025, manufacturers will be required to comply with FDA Medical Device Reporting (MDR) requirements, correction and removal reporting requirements, and quality system requirements for complaint files.
It's good practice to conduct an internal regulatory assessment to ensure you have the resources, processes, and tools in place to successfully meet new requirements for LDT devices. It’s also essential to make sure your team is well-versed in these new requirements and the documentation and timelines involved. Including all relevant stakeholders early on, getting a comprehensive project plan in place, and meeting regularly to ensure all tasks are completed would be helpful during the phaseout period and beyond.
Regarding the LDT changes, the FDA has provided a Q&A sheet that you may find helpful.
If you're looking for guidance on FDA premarket submissions, see our Beginner’s Guides to the FDA 510(k), De Novo, and PMA processes.
How Regulatory Tools Can Help
FDA’s final rule on LDTs will add complexity to the regulatory information management of laboratory diagnostic tests. There are digital solutions that can help manufacturers stay current on updated regulations and manage the additional information and documentation needed because of these updates.
A regulatory intelligence database like Rimsys Intel can provide detailed global market entrance requirements, application timelines, fees, risk class specifications, and documentation needed for medical devices and IVDs so that manufacturers can start preparing their premarket strategies.
Regulatory Information Management (RIM) software like Rimsys can help boost efficiency, reduce compliance risk, and increase collaboration by centralizing regulatory information and automating time-consuming, manual processes. As a result, medical device manufacturers gain complete visibility into their submission management and selling status so that they can plan more effectively, avoid costly product delays, and execute faster.
Quick reference guide - global medical device UDI requirements and timelines
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.
Quick Links to country-specific sections:
- Australia UDI
- Brazil UDI
- Canada UDI
- China UDI
- European Union UDI
- India UDI
- Japan UDI
- Saudi Arabia UDI
- Singapore UDI
- South Korea UDI
- Taiwan UDI
- United States UDI
- UDI databases by country
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).
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.
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.
Health Canada website
Reporting Database: N/A
Position paper on the current state of UDI implementation
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 (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.
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.
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.
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.
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.
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
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).
Guidance document from Taiwan FDA
Reporting Database: TUDID
Taiwan has previously implemented UDI regulations, which include labeling and database reporting requirements.
FDA website for UDI
Reporting database: GUDID database
The United States has previously implemented UDI regulations, which includes labeling and database reporting requirements.
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.
* 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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Why a RIM System is Critical to Successfully Support MedTech M&A Activities
There was significant M&A activity in the MedTech sector in 2024, and the industry is predicting another big year for mergers and acquisitions. As MedTech companies aim to expand their product lines, enter new markets, innovate faster, and remain competitive in a rapidly evolving space, mergers and acquisitions can be attractive and cost-efficient options. Additionally, some manufacturers are choosing to divest parts of their business to hone their focus, drive additional investment in other key areas, and optimize operations.
For the regulatory affairs professional, M&A activities can be anything but efficient. An influx of new products, registrations, and regulatory information to maintain can wreak havoc on RA teams who are already struggling to effectively manage and maintain compliance amid a seemingly constant state of regulatory change.
In an increasingly complex regulatory landscape, many MedTech teams are turning to RIM systems to help them centralize regulatory information across the business, automate time-consuming, manual processes, and strengthen global compliance. These benefits are even more palpable for companies undergoing mergers, acquisitions, and divestitures, giving them streamlined, fully visible regulatory information management that can scale with their evolving business needs and additional regulatory information to manage.
Case Study: Large, Publicly Traded Device Manufacturer Navigates Product Line Divestiture with Ease
A large, publicly traded manufacturer of products for pain management, digestive health, and IV therapy was in the process of divesting one of its product lines to another company. As a result, some of their regulatory employees were transitioned to the company that purchased its product line. The customer leveraged Rimsys’ unique Linked Accounts feature, which allows users to grant external stakeholders controlled access to Rimsys, to give those impacted access to the 100+ registrations associated with the divested products. As a result, the transitioned employees lost no access to their respective products and are able to manage, review, and approve those registrations as they normally would.
“Linked Accounts is a fantastic feature that I didn’t originally appreciate as much. Rimsys made it easy for us to identify the products impacted by the divestiture and provide access to those who need them. It has been a bright spot in the sea of headaches both teams are experiencing when trying to review and approve information in other systems.”
-Program Manager, Regulatory Information Management
When the transaction is complete, the customer will easily be able to export the list of registrations by product tag and archive the registrations in Rimsys for easy management and visibility. The transitioned employees will also still retain access to the information they need in Rimsys as they work to implement their own Rimsys solution to manage those registrations.
Navigating Business and Regulatory Changes with RIM Systems
As the MedTech industry prepares for additional mergers, acquisitions, and divestitures this year, getting a solid regulatory information foundation in place is critical for a successful transition and ongoing compliance. Yet, many MedTech RA teams are using manual processes and siloed systems to manage regulatory information.
One of Rimsys’ goals is to serve as a strategic partner to MedTech RA teams, helping them better understand their current RIM state and the steps they need to advance their processes. This includes the implementation of a RIM system such as Rimsys to centralize their regulatory information, enable easy collaboration with internal and external stakeholders, and automate time-consuming manual processes for strengthened global compliance.
See our Guide to MedTech RIM Maturity, which provides our RIM Maturity Model Framework, for ways to better assess your organization’s current RIM state and incrementally reach new milestones.
Rimsys has helped global MedTech leaders navigate business and regulatory change with unified RIM software that provides full visibility into their regulatory activities. If you’re looking to stay ahead of upcoming strategic activities or are simply looking for a better way to manage your information amid increasing complexity, contact us to learn how Rimsys can help you streamline and automate your processes for long-term success.
