November 08, 2025

Software as a Medical Device (SaMD) is transforming healthcare by enabling intelligent, real-time, data-driven diagnosis, monitoring, and treatment. As digital health technology evolves, regulatory compliance for SaMD has become increasingly complex, with varying standards and expectations across global markets.

For medical device manufacturers, regulatory affairs professionals, and digital health innovators, navigating this fragmented landscape demands a harmonized global regulatory strategy—balancing innovation with compliance.

At Maven Regulatory Solutions, we help organizations decode these complexities, aligning global submissions with evolving SaMD frameworks and ensuring faster, compliant market access.

Understanding SaMD: A New Era in Healthcare Technology

Unlike traditional hardware-based devices, SaMD operates independently of physical components. It uses algorithms, AI/ML models, and real-time data to deliver medical functionality—from early diagnosis to personalized therapy recommendations.

This innovation, however, brings new challenges:

  • How do you classify risk levels for AI-driven decisions?
  • What evidence is required for safety and performance validation?
  • How do data privacy and cybersecurity fit into regulatory expectations?

Each region answers these questions differently, making global market readiness a crucial part of any SaMD go-to-market plan.

Key Regulatory Frameworks for SaMD Across Major Markets

United States – FDA (Food and Drug Administration)

  • Regulated under 21 CFR Part 820 and the FDA Digital Health Policy Framework.
  • Classification based on risk: Class I (low) to Class III (high).
  • The Pre-Submission (Q-Sub) process helps align early with the FDA.
  • Emerging guidance for AI/ML-enabled SaMD and Predetermined Change Control Plans (PCCPs) support adaptive algorithms.

European Union – MDR & IVDR

  • Governed by the Medical Device Regulation (EU) 2017/745.
  • SaMD is classified based on intended purpose and patient risk (Rule 11).
  • Requires Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS).
  • Notified Body involvement is mandatory for Class IIa, IIb, and III devices.

Canada – Health Canada (SaMD under Medical Device Regulations)

  • SaMD must be licensed through the Medical Device Establishment License (MDEL).
  • Classified from Class I to Class IV based on potential harm.
  • Technical documentation must align with IMDRF SaMD WG guidance.

Japan – PMDA (Pharmaceuticals and Medical Devices Agency)

  • SaMD falls under PMD Act.
  • Requires Shonin (pre-market approval) or Nissho (certification) based on risk.
  • Japan emphasizes post-market monitoring and cybersecurity compliance.

Australia – TGA (Therapeutic Goods Administration)

  • Governed by the Therapeutic Goods (Medical Devices) Regulations 2002.
  • Risk classification follows IMDRF principles.
  • TGA harmonization efforts are ongoing with FDA and EU frameworks for AI-based SaMDs.

Global Harmonization Efforts

Organizations like the International Medical Device Regulators Forum (IMDRF) are driving alignment on SaMD definitions, risk frameworks, and quality standards.
 Key IMDRF SaMD documents:

  • SaMD: Key Definitions (IMDRF/SaMD WG/N10:2013)
  • Risk Categorization Framework (IMDRF/SaMD WG/N12:2014)
  • SaMD Clinical Evaluation (IMDRF/SaMD WG/N41:2017)

Adhering to IMDRF principles not only eases global compliance but also demonstrates regulatory maturity to authorities worldwide.

Documentation & Technical File Essentials

A robust SaMD Technical Documentation Package should include:

  • Software Description & Architecture
  • Risk Management File (ISO 14971)
  • Software Verification & Validation (V&V) Evidence
  • Cybersecurity & Data Protection Measures
  • Clinical Evaluation & Performance Data
  • Post-Market Surveillance (PMS) Plan

Aligning documentation with IEC 62304 and ISO 13485:2016 enhances regulatory acceptance globally.

Compliance Best Practices for Global SaMD Success

  1. Start with Regulatory Strategy Design: Define target markets early and map classification criteria for each.
  2. Engagement Regulators Early: Use pre-submission meetings to clarify expectations and mitigate delays.
  3. Implement a Global QMS: Adopt a single, harmonized quality management system that aligns with ISO and regional requirements.
  4. Plan for Continuous Learning AI: Integrate change control and retraining plans for AI-driven SaMD.
  5. Monitor Post-Market Trends: Use real-world performance data to update risk assessments and maintain compliance.

The Future of SaMD Regulation

As AI and machine learning continue to evolve, regulators are focusing on:

  • Transparency and Explainability in AI models
  • Continuous Learning Systems and Real-World Evidence (RWE)
  • Data Integrity and Cybersecurity Governance
  • Collaborative harmonization between FDA, EMA, TGA, and PMDA

Organizations that invest early in regulatory readiness and compliance automation will lead the next phase of digital health transformation.

Maven Regulatory Solutions: Your Partner in Global SaMD Compliance

At Maven Regulatory Solutions, we specialize in end-to-end SaMD regulatory strategy—from classification and documentation to submission and post-market compliance.

Our team helps you:

  • Develop compliant SaMD technical files aligned with global standards
  • Streamline FDA 510(k), CE Marking, and PMDA Shonin submissions
  • Implement risk-based QMS for digital health innovation
  • Achieving faster, safer market entry across multiple jurisdictions

Partner with Maven to simplify your global SaMD journey—bridging innovation and compliance.