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If your software performs a medical function without being part of a hardware device, it's likely classified as SaMD and subject to strict regulations. This guide explains global standards, definitions, and regulatory bodies that govern SaMD in key regions.
You don't need to be a medical device manufacturer to create life-changing medical software. Here are two reasons why!
First, smaller technology companies are successfully developing software on a daily basis. These organizations have expertise in operating systems, development, and rollout processes. They deliver effective development, seamless software implementation, and timely product releases.
Second, healthcare is one of the most regulated industries in the world. If your product violates regulations, it can be removed from the market, result in regulatory fines, or lead to consumer lawsuits. However, if you learn, understand, and apply these rules and regulations, your software may already be on its way to helping patients and users.
The software-as-a-medical-device industry is experiencing unprecedented growth, creating more opportunities for developers worldwide. According to SaMD market projections, “the global SaMD market is projected to reach $5.0 billion by 2033, growing at a compound annual growth rate (CAGR) of 13.6% from $1.4 billion in 2023.” This growth stems from digital adaptation to healthcare and the proven effectiveness of software-based medical solutions. Here's a look at the guidelines for developing healthcare software globally.
SaMD in chapters // Table of Contents
How to Determine If Your Software Qualifies as SaMD?
When it comes to medical devices, they can be used to eliminate manual errors, enhance workflow efficiency, and optimize resource use.
Software as a Medical Device (SaMD) is one of three categories of medical device software. The other two are software that is integral to a medical device (Software in a medical device) and software used in the manufacturing or maintenance of a medical device. The International Medical Device Regulators Forum (IMDRF) defines SaMD as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
Why the SaMD Definition Matters for Your Project?
Firstly, it applies to various technologies, including electronic medical records, medical device platforms, remote patient monitoring systems, and virtual networks. Secondly, IDFR makes up most of the global markets, with the members being (in alphabetical order) Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, the United Kingdom, the United States, and Switzerland. Similar organizations navigating healthcare software regulations in other parts of the world are the African Medical Device Forum (AMDF); the South African Health Products Regulatory Authority (SAHPRA), and the Taiwan Food and Drug Administration (TFDA).
Does Your Software Require SaMD Compliance?
According to the IDFR definition, if your project is “intended for one or more medical purposes” and “performs these purposes without being part of a hardware medical device" - then yes.Operating systems that do not meet the definition of SaMD are - Solutions whose “intended purpose is to drive a hardware medical device.”- Used in combination (e.g., as a module) with other products, including medical devices.In practice, to know where you stand, you need to define your product's intended use (purpose of the solution and what it will be used for) and indications for use (specific conditions that your app will tackle). But if you’re unsure where your healthcare software fits in these legal regulations, it’s best to contact the right institution directly.
Medical device regulatory authorities worldwide
Depending on your location and where you want to release your solution, it would be the matter of reaching out to the right medical device regulatory authority. In alphabetical order:
Region | Regulatory Body | SaMD Regulations |
Australia | Follows ISO 13485 & IEC 62304; classified by risk; must be listed in ARTG; regulated as a medical device. | |
Brazil | Brazilian Health Regulatory Agency (ANVISA) | Follows ISO 13485 & IEC 62304; risk-based classification; high-risk requires clinical data, registration; regulated as a healthcare product. |
Canada | Follows ISO 13485 & IEC 62304; Classified I-IV; high-risk need licenses; regulated as a healthcare product. | |
China | Follows ISO 13485; classified into ClassIC-III; higher risk needs registration & testing. | |
European Union | European Commission - Directorate-General for Health and Food Safety | Regulated under MDR & IVDR; CE marking; high-risk need notified body approval; conform to conformity assessment. |
Japan | Risk-based regulation; higher-risk needs pre-market approval; requires safety & efficacy documentation. | |
Russia | Regulated as a medical device; classified by risk; required certification, registration; follows GOSt & international standards. | |
Singapore | Regulated as a medical device; classified A-D; higher classes need licensing, ISO 13485, & surveillance. | |
South Korea | Follows ISO 13485, IEC 60601, IEC 62304; classified I-IV; high-risk requires approval & clinical data. | |
United Kingdom | Regulated under UK MDR 2002 & UKCA; high-risk devices need approval; aligned with EU MDR. | |
United States | Regulated as a medical device; classified I-III; many need 510(k), De Novo, or PMA; focuses on safety & cybersecurity. | |
Switzerland | Follows ISO 13485, IEC 62304; regulated as a medical device; high-risk need registration, clinical evaluation, surveillance. |
Aiming to ensure global quality standards and policy unity, beyond IDFR and its members, numerous renowned institutions collaborate and regulate the IDFR itself. The World Health Organization (WHO); Swissmedic, Argentina, National Administration of Drugs, Food, and Medical Devices have the status of Official Observers. And “Regional harmonization initiatives”, such as APEC LSIF Regulatory Harmonization Steering Committee; Global Harmonization Working Party (GHWP); Pan American Health Organization (PAHO); and African Medical Devices Forum (AMDF) – among others.
According to the European Commission's Implementing Decision (EU) 2025/1324, enacted in July 2025, the expert advisory system is expanded to help keep pace with advances in medical technology, ensuring safety and supporting innovation. This decision helps manufacturers acquire better guidance, faster regulatory decisions, and allows for advanced oversight of increasingly complex medical devices, particularly AI and digital health technologies.In practice, this means that your healthcare software needs to meet regulations of, well, two-and-a-half regulatory bodies and gives you at least three points of contact: - IDFR (for software as medical device global guidelines), - Local authorities (for regulations in specific locations), - External institutions oversee both regulatory frameworks.
Examples and Case Studies
Naturally, no matter the stage of your development, you can learn from other solutions that are already available on the market. Here are two examples that are not software as a medical device and two that are SaMD.
Examples of applications
- Software embedded in the medical hardware device. That's glucose meters, insulin pumps, and defibrillators, among others.
It's a software that doesn't function as a medical device on its own. Instead, it monitors and analyzes the performance and operation of medical devices. It also alerts owners, doctors, or technicians when devices need servicing or replacement.
- Software allowing for clinical communication and workflow. That includes.
These applications don't function as medical devices themselves. Instead, they help patients and users connect with healthcare providers.
Examples of software that
Any health monitoring apps. These mobile applications collect and interpret health data, whether it's on your Apple Watch or smartphone. They provide individualized recommendations and advice on everything from sleep patterns to exercise routines.
In Untitled Kingdom, we have developed FemTech (female technology) – from an app for a smart menstrual cup and a diagnosis device for pelvic assessment to an online endometriosis education toolset.
Any online diagnostic tools. That's any algorithm that analyzes health data – from medical images (MRIs or X-rays) to offering personalized treatment options, such as Untitled Kingdom's software for wireless ultrasound, patient companion apps, and a remote patient monitoring app for Remedee Labs.
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And naturally, with many examples to learn from, you do not need to face these regulations alone. For starters, you can book a free online consultation and learn how to navigate the development of your medical software further.
Resources
FDA documents - accessed December 20, 2023 - HERE
Is your software a medical device? - guideline issued by European Commission - accessed December 20, 2023 - HERE
Software as a Medical Device (SaMD): Key Definitions - Issued by IMDRF - accessed July 28, 2025 - HERE
4 Health teach services,1 patient-centered approach - Issued by Untitled Kingdom - July 28, 2025 - HERE
Why do we distinguish FemTech products from other tech products? - Issued by Untitled Kingdom - July 28, 2025 - HERE
New regulation - issued by the European Commission - July 28, 2025 - HERE
Software as a Medical Device (SaMD): Key Definitions - Issued by IMDRF - July 28, 2025 - HERE
The Future of Software as a Medical Device: What to Expect in 2025 - issued by Dash Technologies INC - July 28, 2025 - HERE
How the Internet of Medical Things Is Transforming Healthcare through Connected Patient-Centered Medicine - Issued by Monterail - July 28, 2025 - HERE
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