As software continues to transform healthcare, Software as a Medical Device (SaMD) has emerged as a powerful engine of innovation. From AI-driven diagnostic tools to mobile apps for chronic disease management, software is no longer just supporting medical devices, it is the device.
And while the opportunities are immense, so too are the regulatory challenges. Unlike traditional hardware, SaMD evolves quickly.
New releases, frequent patches, and the integration of machine learning demand a fundamentally different approach to regulatory compliance; one that’s fast, flexible, and always up to date. For regulatory affairs teams, this means navigating a complex, fast-moving landscape where requirements shift by region, risk class, and technology type.
This guide is designed to cut through that complexity. Whether you’re building your first SaMD product or managing a global portfolio, we’ll walk through what qualifies as SaMD, how major markets approach regulation, and what it takes to stay compliant.
What Counts as SaMD?
Let’s start with the basics: what actually qualifies as Software as a Medical Device?
According to the International Medical Device Regulators Forum (IMDRF), SaMD is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In simpler terms, it’s standalone software that carries out a medical function (whether diagnosing, treating, preventing, or monitoring disease) without being embedded in a physical product.
This could be anything from a clinical decision support tool to an AI-powered diagnostic algorithm or a digital therapeutic app for mental health. SaMD is not your electronic health record system or patient scheduling tool, it has to fulfill a medical purpose, not just an administrative one.
Different regulatory bodies have slightly different definitions and interpretations, but the core concept is the same across the board. The FDA, the EU under MDR, and regulators in countries like Canada, Japan, and Australia all recognize and regulate SaMD in its own category.
A Global Patchwork: Navigating SaMD Regulations Worldwide
There’s no single playbook for bringing SaMD to market. Instead, MedTech teams face a patchwork of global regulations, each with its own nuances.
In the United States, the FDA offers multiple pathways depending on the software’s risk classification 510(k), De Novo, or PMA. The agency has also explored software-specific initiatives, such as the now-retired Software Precertification Pilot, and continues to refine its approach to AI/ML-based SaMD.
Across the Atlantic, the European Union’s Medical Device Regulation (EU MDR) classifies most SaMD under Rule 11, which often places software in higher-risk categories than teams expect. Clinical evaluation is a must, and CE marking is only the beginning of ongoing postmarket responsibilities.
Other major markets bring their own frameworks to the table. The UK’s MHRA is in the midst of updating its regulatory regime post-Brexit.
Health Canada and Australia’s TGA offer specific guidance for software, and Japan’s PMDA continues to provide detailed oversight, especially for AI-driven tools. What all these frameworks have in common is change.
Regulations are constantly evolving to keep up with innovation, which makes staying compliant a moving target, especially if you’re operating in multiple markets.
Compliance, Reimagined for Software
To build and maintain compliance in this environment, regulatory teams need to think beyond checklists. SaMD introduces a new set of considerations that touch every stage of the product lifecycle.
Risk classification is a foundational step, but it can vary widely by region. What’s considered low risk in one market might trigger a more rigorous review in another.
From there, cybersecurity becomes critical, not just as a technical requirement, but as a regulatory expectation. Secure-by-design architecture, data protection protocols, and real-time vulnerability monitoring are no longer optional. Clinical evaluation must go beyond basic evidence.
Regulators want to see real-world performance data, clinical literature, or trials that validate the software’s effectiveness. For AI and machine learning models, the bar is even higher: adaptive algorithms must be explainable, validated, and version-controlled.
Documentation is another major pillar. Standards like IEC 62304 provide a blueprint for software lifecycle documentation, but following them requires discipline and often, significant collaboration across development, QA, and clinical teams.
And then there’s the reality of postmarket change. Every software update, however minor, could require reassessment or even re-submission depending on the market.
That’s a logistical and regulatory challenge that many teams struggle to manage manually.
Why Compliance Gets Complicated
Compliance isn’t just a matter of submitting the right paperwork. It’s an ongoing effort that depends on coordination, documentation, and speed.
One of the biggest obstacles? The pace of software development.
Engineering teams work in agile sprints. Regulators don’t. That disconnect can make it difficult to align product updates with submission timelines.
There’s also the challenge of version control. With every patch or algorithm tweak, documentation must be updated and tracked across potentially dozens of markets, formats, and versions.
Add in the need for clinical validation, cybersecurity assurance, and regulatory intelligence, and it’s no surprise that teams often feel overwhelmed. This is where manual processes start to break down.
Without a centralized way to manage submissions, changes, and global requirements, teams risk duplication, delays, and even non-compliance.
A Smarter Way to Manage SaMD: How RIM Platforms Help
Enter modern Regulatory Information Management (RIM) platforms. Designed to bring structure, speed, and clarity to the regulatory process, RIM systems are becoming essential for MedTech teams managing SaMD products.
With RegDesk, for example, teams can centralize all regulatory documents, evidence, and submission materials in one place. This not only streamlines collaboration but also ensures that teams are always working from the latest, approved version which is critical when updates are frequent.
Beyond document management, RegDesk provides real-time insights into global regulatory requirements by country and product type. Teams can proactively monitor changes, manage timelines, and generate region-specific submissions without starting from scratch each time.
Built-in tools like modular submission builders and automated change tracking help regulatory teams move at the pace of product development without sacrificing accuracy or compliance.
Best Practices for Staying Ahead
While no system can remove all the complexity of SaMD compliance, the right strategy makes it manageable. Start by integrating compliance into the development lifecycle from day one.
This means building risk management, clinical validation, and cybersecurity into your design controls, not adding them on at the end.
Create a documentation framework that’s scalable. Templates, naming conventions, and version tracking should support your team’s ability to update and adapt without confusion.
Stay informed. Regulations change fast, and without access to real-time regulatory intelligence, your strategy can quickly become outdated.
And finally, collaborate early and often. SaMD compliance is a team sport. Regulatory, clinical, engineering, and quality teams must stay in sync, not just during submissions, but throughout development and maintenance.
Conclusion
SaMD opens new doors for improving care and expanding access but it also demands a new regulatory mindset. With the right tools, cross-functional alignment, and a proactive approach, MedTech companies can manage compliance not as a burden, but as a competitive advantage.
The future of digital health depends on it. Want to simplify SaMD compliance across markets?
RegDesk helps MedTech teams stay ahead of change with smarter regulatory management tools.
