What are the Global SaMD Standards: Regulations for Medical Software

What Is Software as a Medical Device (SaMD)?
What is the International Medical Device Regulatory Forum (IMDRF)?
Does My Healthcare Software Qualify as SaMD?
Navigating Global SaMD Regulations
SaMD vs Non-SaMD: Real-World Case Studies
Turn Compliance into Competitive Advantage
Resources:

Software as a Medical Device (SaMD) is one of the fastest-rising sectors in digital health, expanding from $1.4 billion in 2023 to a projected $5.0 billion by 2033 at a 13.6% CAGR. This growth is fueled by advancements in AI diagnostics, remote monitoring, and digital therapeutics; however, success in this market hinges on navigating a complex web of international regulations. For investors, understanding these regulatory frameworks is essential: compliance determines not only speed to market but also scalability across regions. Companies that master global SaMD standards early gain a decisive competitive edge, while those that misstep risk costly delays, fines, or product withdrawals.

Technology companies leverage expertise in agile development, cloud infrastructure, and user experience design to create FDA-approved medical software. However, healthcare remains highly regulated, and violations can result in market removal, regulatory fines, or consumer lawsuits.

Before diving into the specific standards, it’s essential to understand what actually qualifies as Software as a Medical Device. This classification determines the risk category, compliance pathway, and which global authorities you’ll need to work with.

What Is Software as a Medical Device (SaMD)?

Medical devices eliminate manual errors, enhance workflow efficiency, and optimize resource utilization. SaMD represents one of three medical device software categories:

Software as a Medical Device (SaMD) - Operates independently
Software in a Medical Device (SiMD) - Integral to hardware
Software for Manufacturing/Maintenance - Used in the device lifecycle

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. This single definition determines your entire regulatory path. If your software includes AI diagnostic tools, remote patient monitoring apps, clinical decision support systems, or digital therapeutics, it qualifies as SaMD and requires compliance with global medical device regulations, including FDA guidelines, EU MDR requirements, and Health Canada standards.

What is the International Medical Device Regulatory Forum (IMDRF)?

Knowing which countries participate in IMDRF helps you anticipate where regulatory requirements are already aligned — and where they may differ. This insight becomes crucial when you’re deciding which markets to target first and how to structure your compliance roadmap.

The IMDRF encompasses most global markets, with members including Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, the United Kingdom, the United States, and Switzerland.

Additional regulatory bodies that oversee healthcare software regulations include the African Medical Device Forum (AMDF), South African Health Products Regulatory Authority (SAHPRA), and Taiwan Food and Drug Administration (TFDA).

Does My Healthcare Software Qualify as SaMD?

Under IMDRF guidelines, your software qualifies as SaMD if it's designed for medical purposes and functions independently of hardware devices.

Software that does NOT qualify as SaMD

Solutions designed to drive hardware medical devices
Software used as modules within other medical devices

To determine if your software qualifies as SaMD:

Define your intended use — clearly state the solution’s medical purpose.
Specify indications for use — outline the exact conditions or populations addressed.
Check IMDRF definitions to confirm independence from hardware.
Consult regulatory authorities if classification is unclear.

Once you've confirmed that your product meets the definition of SaMD, the next step is to map your compliance strategy to your target markets. Each region has its own authority, approval process, and risk classifications, allowing early research to save months, or even years, in product launch timelines.

Navigating Global SaMD Regulations

Once you’ve determined whether your software qualifies as SaMD, the next challenge is navigating the patchwork of regulations across global markets. Your regulatory path depends on target markets and location. Here are the key regional authorities:

Region	Regulatory Body	SaMD Regulations
Australia	Therapeutic Goods Administration (TGA)	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	Health Canada	Follows ISO 13485 & IEC 62304; Classified I-IV; high-risk need licenses; regulated as a healthcare product.
China	National Medical Products Administration	Follows ISO 13485; classified into Class I-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	Pharmaceutical and Medical Devices Agency (PMDA)	Risk-based regulation; higher-risk needs pre-market approval; requires safety & efficacy documentation.
Russia	Russian Ministry of Health	Regulated as a medical device; classified by risk; required certification, registration; follows GOST & international standards.
Singapore	Health Sciences Authority	Regulated as a medical device; classified A-D; higher classes need licensing, ISO 13485, & surveillance.
South Korea	Ministry of Food and Drug Safety	Follows ISO 13485, IEC 60601, IEC 62304; classified I-IV; high-risk requires approval & clinical data.
United Kingdom	Medicines and Healthcare products Regulatory Agency (MHRA)	Regulated under UK MDR 2002 & UKCA; high-risk devices need approval; aligned with EU MDR.
United States	U.S. Food and Drug Administration (FDA)	Regulated as a medical device; classified I-III; many need 510(k), De Novo, or PMA; focuses on safety & cybersecurity.
Switzerland	Swissmedic	Follows ISO 13485, IEC 62304; regulated as a medical device; high-risk need registration, clinical evaluation, surveillance.

SaMD vs Non-SaMD: Real-World Case Studies

Regulations can feel abstract until you see how they apply to real products. The following examples show how intended use, functionality, and claims determine whether software is classified as SaMD — and therefore subject to medical device regulations.

Software Classified as SaMD

Clinical Health Monitoring Applications

Example: An app that monitors heart rate and flags arrhythmias, intended for patients with cardiac conditions.
Why SaMD: It is intended for the diagnosis and monitoring of a specific medical condition, independent of hardware.
Regulatory Note: Requires classification and compliance per risk level (Class I–III in FDA, Class I–III in EU MDR).

FemTech Solutions with Diagnostic or Treatment Intent

Example: An app that analyzes menstrual cycle data to diagnose polycystic ovary syndrome (PCOS) or assess fertility.
Why SaMD: Intended to provide clinical insights for diagnosis or treatment decisions.
Regulatory Note: FemTech with only tracking and lifestyle advice is typically non-SaMD; claims matter.

AI-Based Diagnostic Tools

Example: Software that analyzes MRI scans to detect tumors or suggests personalized treatment plans.
Why SaMD: Performs diagnosis and treatment recommendation functions without being tied to a specific hardware device.
Regulatory Note: May require extensive clinical validation and algorithm change control processes.

Digital Therapeutics (DTx)

Example: Cognitive behavioral therapy (CBT) software is prescribed for depression or anxiety.
Why SaMD: Intended to treat a medical condition through a therapeutic intervention delivered via software.
Regulatory Note: Often requires randomized clinical trial evidence before approval.

Software Not Classified as SaMD

Software Embedded in Medical Hardware

Example: Glucose meter firmware, insulin pump control software, or defibrillator operation systems.
Why Not SaMD: These programs are Software in a Medical Device (SiMD) — they are integral to the hardware’s function and cannot operate independently.
Regulatory Note: They are still regulated as part of the overall device, but follow a different compliance path from SaMD.

Device Performance Monitoring Tools

Example: Apps that alert service teams when a device requires maintenance or replacement.
Why Not SaMD: These applications are used for asset management or servicing, not for diagnosing, preventing, or treating medical conditions.
Regulatory Note: Covered under quality management or manufacturing software requirements, not SaMD rules.

General Clinical Communication or Workflow Software

Example: Scheduling systems, internal messaging platforms, or generic electronic health record (EHR) modules without diagnostic or therapeutic functionality.
Why Not SaMD: These tools do not process patient data for medical purposes; they simply facilitate workflow and communication.
Regulatory Note: Many still require healthcare IT compliance (e.g., HIPAA, GDPR) but not SaMD clearance.

Consumer Wellness Apps

Example: A heart-rate tracker marketed for fitness improvement or sleep monitoring without medical claims.
Why Not SaMD: These are “general wellness products” under FDA guidance and are not regulated as medical devices unless linked to a clinical claim.
Regulatory Note: Changing marketing language to make clinical claims would trigger SaMD classification.

Turn Compliance into Competitive Advantage

Whether you’re building an AI-powered diagnostic tool or a digital therapeutic app, global SaMD compliance isn’t just about avoiding penalties; it’s about building trust, ensuring safety, and unlocking new market opportunities.

Get expert guidance on SaMD. Ready to take the next step? Book a consultation with Monterail to develop a strategic and scalable solution that meets the global medical device standards worldwide.