Global Market Expansion for SaMD – Unlocking Access Across Key Markets

Expanding a Software as a Medical Device (SaMD) into global markets demands a clear understanding of regulatory expectations across regions. Masuu Global Solutions provides the strategic expertise needed to navigate diverse approval pathways, ensuring your SaMD meets country specific requirements and reaches new markets with confidence.

Global SaMD Approval Strategy – Expanding Your Reach

Taking SaMD solutions global requires not only innovation but also the ability to interpret and comply with regulatory frameworks that differ significantly between regions. Masuu Global Solutions helps you simplify these complexities and accelerate global entry.
We support SaMD approvals across major authorities, including:
  • U.S. FDA
  • European Union (EU MDR)
  • Australia’s TGA
  • Health Canada
  • Japan PMDA
  • China NMPA
  • Brazil ANVISA
  • South Korea MFDS
Our global regulatory strategies are scalable, agile, and region specific, designed to help you comply with requirements such as:
  • SaMD risk classification
  • Cybersecurity standards
  • UDI systems
  • Clinical evidence expectations
  • AI/ML specific regulatory guidelines
With Masuu Global Solutions, you can:
  • Reduce time to market using tailored regulatory roadmaps
  • Minimize risks through early gap analysis and proactive mitigation
  • Ensure alignment with ISO standards, IMDRF principles, and digital health frameworks
  • Manage documentation, submissions, and localization across multiple regions seamlessly
From early stage planning to post market support, Masuu helps your SaMD succeed across borders.

Who We Serve

  • Startups & Innovators
  • Fast growing companies expanding into new regions
  • Large enterprises & multinationals seeking global harmonization

How We Serve

Supporting New Products in Existing Markets

  • Optimize SaMD submissions for faster approval
  • Ensure documentation aligns with current local regulations

Supporting New Products Entering New Markets

  • Develop regulatory strategies from scratch for early stage products
  • Manage complete submission preparation for global market entry

Supporting Approved Products Expanding to New Regions

  • Interpret and align with region specific requirements
  • Adapt existing documentation to satisfy new regulatory expectations

Supporting Changes in In Country Representation

  • Facilitate transitions or updates to local authorized representatives
  • Ensure continuous compliance with regional authorities

Supporting as a Contract Legal Manufacturer

  • Serve as the legal manufacturer under ISO 13485:2016
  • Maintain compliance and licenses across 50+ markets
  • Provide complete QMS coverage, enabling you to focus on innovation

Applicable Global Standards We Implement

Standard Scope
FDA 21 CFR Part 820 U.S. Quality System Regulation for SaMD
EU MDR 2017/745 Medical Device Regulation in the EU
TGA (Australia) Regulations for SaMD under the Therapeutic Goods Administration
MFDS (South Korea) Korea’s regulatory framework for SaMD
ISO 13485 Global standard for medical device QMS
IEC 62304 Software lifecycle standard for SaMD
ISO 14971 Risk management for SaMD development

Masuu’s Global Market Expansion Services for SaMD

Regulatory Strategy Consultation for Global Expansion

We develop customized global strategies aligned with your target markets — whether the U.S., EU, Australia, South Korea, or other regions — ensuring submission processes are efficient, compliant, and market ready.

SaMD Registration in Key Global Markets

From FDA 510(k) to EU MDR conformity and Australia’s TGA processes, we support all steps necessary to register your SaMD, backed by complete documentation, clinical evaluation, and risk management support.

Australia TGA Registration

We manage classification, documentation, and regulatory submissions to ensure seamless approval under TGA guidelines.

South Korea SaMD Registration (MFDS)

We guide you through MFDS requirements — from premarket submissions to post market surveillance — ensuring smooth access to the Korean digital health market.

Risk Management – ISO 14971

Our experts help you implement globally accepted risk management practices and maintain compliant risk documentation.

Clinical Evaluation & Post Market Surveillance

We develop CERs, PMS plans, and ongoing monitoring frameworks required for continuous compliance across global regions.

Challenges vs. Your Benefits with Masuu’s SaMD Solutions

Complex & Evolving Regulations

Challenge: Navigating diverse frameworks (FDA QSR, MDR, ISO standards, GDPR) is time intensive.

Your Benefits:
  • Fast, audit ready compliance
  • Access to pre built ISO aligned frameworks

High Costs & Fragmented Efforts

Challenge: Multiple stakeholders increase costs and inefficiencies.

Your Benefits:
  • Full QARA team at a predictable monthly cost
  • Over 50% savings compared to in house hiring
  • Near full coverage for less than the cost of 1 FTE

Long & Risk Prone Timelines

Challenge: QMS setup, CE marking, and FDA approvals can take months to years.

Your Benefits:
  • Reduce certification timelines by months
  • Prevent costly documentation rework
  • Save €50K+ in QMS and eQMS setup costs
  • High success rate in global registrations
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