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Software as a Medical Device (SaMD) Classification and Registration

Based on risk evaluation as well as inclusion and exclusion criterion, our medical device license experts will assist in registering your SaMD with Health Canada or the FDA.

The regulatory landscape for Software as a Medical Device (SaMD) is constantly evolving to keep pace with advancements in technology and ensure patient safety. Regulatory bodies, such as Health Canada, and the FDA in the United States. Here is everything you should know about Software as a Medical Device.

Software as a Medical Device - Classification and Registration in Canada & USA

Health Canada defines software as a medical device (SaMD)  as a software intended to be used for one or more medical purposes and performs these purposes without being part of a hardware medical device. SaMD includes in-vitro diagnostic (IVD) medical devices and can run on non-medical computing platforms.

There are inclusion and exclusion criteria that must be met to determine if a device meets the definition of an SaMD. Health Canada follows standards developed by the International Medical Device Regulators Forum (IMDRF) in this criterion determination if the software is a medical device.

SaMD can apply to any of the four classes of medical devices that are under the classification system in Canada.

The FDA’s SaMD Pre-Certification Program is a notable initiative aimed at streamlining the regulatory process for SaMD. Under this program, software developers who demonstrate a robust culture of quality and organizational excellence can be pre-certified, allowing for a more streamlined review process for their SaMD products. This program promotes an agile and iterative approach to software development, focusing on the evaluation of the developer’s capability to deliver safe and effective software products.

In addition to the FDA, other regulatory bodies, such as the European Commission and the Medical Device Coordination Group (MDCG), have also developed guidelines and regulations for SaMD. These regulations aim to ensure the safety, effectiveness, and quality of SaMD across different regions.

IEC 62304 Standard and Software Risk Classification for SaMD

The standards followed by Health Canada for SaMD is IEC 62304.  This harmonized standard is specifically created for medical device software.  There are 3 levels of software risk that Health Canada follows for SaMD (FDA follows 4 levels of software risk).  These 3 levels are defined as follows:

Class A – no injury, death or hazardous outcome possible

Class B –  no serious injury outcome though a hazardous situation is possible

Class C – death or serious injury is possible through a hazardous situation

This risk analysis and determination requires extensive documentation to support the class in which the device software falls into.

Software as a Medical Device
SaMD

FDA Software Risk Classification based on IEC 62304

There are 4 risk categories for SaMD under the FDA framework.

Category 1 – Low impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 2 – Medium impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 3 – High impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 4 – Very high impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

How Quality Smart Solutions can assist with your SaMD registration

The first step in our process is determining what class your device is and secondly, determining what risk classification your SaMD falls under based on the country of registration.

Upon determining class and risk categorization, a technical dossier will be prepared following IEC 62304 standards.  When the technical dossier is completed, the medical device license application (if applicable) is prepared for submission to Health Canada and/or FDA.

Software as a Medical Device
Health Canada regulatory framework for Software as a Medical Device SAMD

How to establish Quality Assurance Systems for your medical devices?

It is important to establish a Quality Assurance System when producing medical devices, as this will help ensure that your products are safe and effective. Quality assurance systems should include documentation of all activities associated with product development, manufacturing, and customer service. This documentation should include product design reports that detail risk assessments, substantiation of compliance assurance plans, and verification tests performed throughout the production process.

What Software as a Medical Device submission documents are required?

For Software as a Medical Device to be approved and certified by Health Canada, you must submit an application package containing the following documents: Regulatory History Form; Device Master Record; Substantial Equivalence Report; Clinical Evaluation Reports; Design Verification & Validation Reports; Test Protocols; Post Market Surveillance Plan; Labelling & Instructions for Use.

Health Canada regulatory framework for Software as a Medical Device SAMD
Health Canada regulatory framework for Software as a Medical Device SAMD

What are the steps for compliance and recertification for your SaMD?

Once a SaMD has been approved by Health Canada and placed on the market for sale, companies must follow specific guidelines in order to maintain compliance. These include regular recertification that examines and confirms the product still meets regulatory requirements. Additionally, manufacturers are responsible for carrying out post-market surveillance activities that analyze customer feedback and any other relevant data collected in order to ensure customer safety throughout the life of the product.

What are the critical challenges in the development of SaMD?

  1. Ensuring the software application’s accuracy and reliability *Developers must establish rigorous testing and validation processes to ensure the software functions as intended and provide reliable results.
  2. Interoperability of SaMD with existing healthcare systems and devices *Developers must consider the various data formats, standards, and communication protocols to ensure interoperability and data exchange.
  3. Privacy and security *Developers must comply with regulations such as the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR) to ensure the privacy and security of patient information.
challenges in the development of SaMD?
7. Post-market surveillance

Steps in the development process of SaMD

1. Conceptualization 2. Requirements gathering 3. Design and architecture 4. Implementation and Coding 5. Verification and validation 6. Documentation and regulatory submission 7. Post-market surveillance

Adhering to best practices throughout the development process, such as risk management, user-centered design, and comprehensive testing, is essential to ensuring the safety and effectiveness of SaMD.

Challenges and Considerations in Developing Software as a Medical Device

  1. One of the main challenges is the need for collaboration between software developers and healthcare professionals.
  2. Another challenge is the rapidly evolving nature of technology. SaMD developers must keep pace with technological advancements and ensure that their Software remains up-to-date and compatible with emerging technologies.
  3. Considerations such as data privacy and security are also paramount in the development of SaMD.
Challenges and Considerations in Developing Software as a Medical Device

Frequently Asked Questions

Health Canada defines software as a medical device (SaMD)  as a software intended to be used for one or more medical purposes and performs these purposes without being part of a hardware medical device.  SaMD includes in-vitro diagnostic (IVD) medical devices and this software can run on non-medical purpose computing platforms.

There are inclusion and exclusion criteria that must be met to determine if they meet the definition of a SaMD. Health Canada follows standards developed by the International Medical Device Regulators Forum (IMDRF) in this criterion determination if the software is a medical device.

SaMD can apply to any of the four classes of medical devices that are under the Health Canada medical device classification system.

Software as a Medical Device (SaMD) is software that is used for at least one medical purpose but is not a part of a medical device’s hardware.  This type of software is defined by the Medical Device Regulations Forum (IMDRF).  The only pre-requisite for obtaining registration is the existence of an ISO 13485 certificate.  To learn the full process for registering your SaMD contact us at info@qualitysmartsolutions.com.

The standard followed by Health Canada for SaMD is IEC 62304.  This harmonized standard is specifically created for medical device software. 

There are 3 levels of software risk that Health Canada follows for SaMD (FDA follows 4 levels of software risk).  These 3 levels are defined as follows:

Class A – no injury, death, or hazardous outcome possible

Class B – no serious injury outcome though a hazardous situation is possible

Class C – death or serious injury is possible through a hazardous situation

This risk analysis and determination requires extensive documentation to support the class into which the device software falls.

There are 4 risk categories for SaMD under the FDA framework.

Category 1 – Low impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 2 – Medium impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 3 – High impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 4 – Very high impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

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