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Software as a Medical Device (SaMD) Registration
As the digital health field evolves, understanding and complying with regulatory requirements is crucial for successful market entry and ensuring product safety and efficacy. Navigating the regulatory landscape for SaMD registration and meeting software-specific medical device standards requires deep expertise and strict adherence to defined guidelines.
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Software as a Medical Device (SaMD) Registration Overview
Software as a Medical Device (SaMD), also known as Medical Device Software (MDSW), is an emerging and rapidly growing segment in the healthcare industry. The global SaMD market is projected to reach USD 86.5 billion by 2027, growing at a CAGR of 21.9% from 2020 to 2027. This surge is driven by factors such as the rise in IoT adoption, the expansion of digital health platforms, and the use of software for continuous monitoring of physiological parameters to support remote care. The COVID-19 pandemic has further accelerated this trend, reinforcing the need for streamlined SaMD registration processes.
There are three major categories of software associated with medical devices:
- Software in a Medical Device (SiMD)
- Software as a Medical Device (SaMD)
- Software used in the manufacturing/maintenance of medical devices
Global Regulatory Scenario
SaMDs serve various functions including screening, diagnosis, monitoring, alerting, and disease management. Health authorities in developed and highly regulated markets like the US, EU, Canada, and Australia have established specific regulations for SaMDs, with some already issuing detailed guidance. In semi-regulated and non-regulated markets, SaMD is often considered under broader medical device definitions, and regulatory practices align with international harmonized guidelines.
Key global guidelines for SaMD include:
- IMDRF guidance on classification, QMS, cybersecurity, and clinical evaluation
- EU MDR provisions for software as a device
- MDCG documents for SaMD qualification, classification, and CER/PER requirements
- US FDA guidance on cybersecurity, clinical validation, and regulatory requirements for software types like decision-support tools, PACS, and mobile apps
- Health Canadaās classification and definition guidance
- TGA Australia's software-based medical device regulations (effective August 2020)
For other international markets, SaMD registration typically requires a case-by-case approach involving direct engagement with local health authorities. The general SaMD registration process involves:
- Determining if the software qualifies as SaMD
- Risk-based classification
- Identifying applicable standards and data requirements
- Generating data per regulatory expectations
- Compiling technical documentation
- Submission, query resolution, and approval
- Post-approval lifecycle management
Pharma Wizardās End-to-End Regulatory Support for SaMD
Pharma Wizard offers comprehensive regulatory support for SaMD registration and compliance across global markets, ensuring alignment with evolving standards and faster time-to-market.
Software as a Medical Device (SaMD) Registration Services
Regulatory Roadmap Consultation for SaMD
Navigate the global compliance landscape with expert guidance. Our team helps you develop a step-by-step regulatory strategy to bring your SaMD product to market efficiently.
Quality Management Systems Implementation
Ensure full regulatory compliance through tailored QMS development. We assist in establishing, maintaining, and auditing Quality Management Systems aligned with ISO 13485 standards.
Global Market Expansion for SaMD
Ensure full regulatory compliance through tailored QMS development. We assist in establishing, maintaining, and auditing Quality Management Systems aligned with ISO 13485 standards.
SaMD Registration in the US
Accelerate your international growth with our SaMD market entry expertise. We manage registration, localization, and documentation for seamless access to global markets.
SaMD Registration in the EU
Simplify FDA registration for your SaMD product. Our experts prepare and submit documentation that meets U.S. regulatory requirements for faster product approval.
Software as a Medical Device (SaMD) Registration - Expertise
- Regulatory Intelligence Services
- Regulatory Due Diligence / Strategy Reports
- Qualification and Classification of SaMD
- Identification of Applicable Standards
- Gap Analysis of Source Documents
- SaMD Registration
- Quality Management System (QMS) Compliance
- Consultation Services for Cybersecurity Assessment
- Consultation Services on Clinical Evaluation Studies
- Compilation of Clinical Evaluation Reports (CERs) / Product Evaluation Reports (PERs) Etc.
- Post-approval Change Management
