What is MedAi?
MedAi is a cutting edge, AI-powered, health information platform designed for both patients and healthcare professionals. It uses augmented intelligence to consolidate and present established medical reference information in plain, accessible language. MedAi is built to support health literacy, help users have more informed conversations with their healthcare providers, and guide individuals toward appropriate professional care when needed.
What are MedAi’s core functions?
MedAi's core functions include the following:
Where does MedAi get its information?
MedAi draws exclusively from authoritative, publicly available medical sources, including approved drug product labelling, published clinical practice guidelines, and established clinical reference ranges. All information presented by MedAi is independently verifiable by qualified healthcare professionals.
Does MedAi diagnose or treat medical conditions?
No. MedAi does not generate novel clinical conclusions, issue patient-specific diagnoses, or provide definitive treatment recommendations. MedAi does not replace the clinical judgement of a licensed healthcare professional. It is a reference and information tool, not a diagnostic or therapeutic one.
Is MedAi considered a medical device in Canada?
No. Health Canada regulates software as a medical device when it meets specific criteria set out in the Medical Devices Regulations under the Food and Drugs Act. Based on a thorough analysis applying Health Canada's Software as a Medical Device (SaMD): Definition and Classification guidance, MedAi does not meet the definition of a medical device and is therefore not subject to those Regulations.
Is MedAi a Medical Device Data System (MDDS)?
No. Health Canada defines a Medical Device Data System as hardware or software that transfers, stores, converts, or displays data originating from a medical device. MedAi does not connect to, receive data from, or interact with any medical device in any way. This category does not apply to MedAi.
How does Health Canada categorize MedAi functionally?
Health Canada's guidance recognizes two broad functional categories of health information software: Clinical Decision Support (CDS) software, intended for healthcare professionals, and Patient Decision Support (PDS) software, intended for patients and caregivers. MedAi fits the functional description of both, as it serves clinical and non-clinical users by presenting established reference information on health conditions, medications, symptoms, and care pathways and management.
If MedAi is CDS and PDS software, why isn't it regulated as a medical device?
Not all CDS and PDS software is subject to Health Canada's Medical Devices Regulations. Health Canada's guidance sets out four specific exclusion criteria. Software that meets all four criteria is not considered a regulated medical device.
What are the four exclusion criteria and how does MedAi meet them?
1. MedAi does not process medical device signals or images.
MedAi does not acquire, process, or analyze any medical image, in-vitro diagnostic device signal, or signal acquisition system output.
2. MedAi presents established reference information.
MedAi displays drug labelling, clinical guidelines, and other established medical reference information routinely used in clinical practice and self-care — exactly the type of software Health Canada identifies as meeting this criterion.
3. MedAi informs decisions but does not drive immediate clinical action.
MedAi is designed to inform users, not to direct or trigger immediate or near-term clinical interventions. Health Canada's guidance recognizes this as a key distinction for software that supports rather than drives healthcare decisions.
4. MedAi does not replace clinical judgement of a licensed healthcare professional
MedAi does not make definitive clinical decisions on behalf of users. All outputs are sourced from publicly available, authoritative references that users and healthcare professionals can independently review and verify.
What is the final regulatory determination in Canada? Is MedAi regulated as software as a medical device (SaMD)?
Applying Health Canada's SaMD: Definition and Classification guidance, MedAi is characterized as Clinical Decision Support and Patient Decision Support software that satisfies all four Table 1 exclusion criteria.
MedAi is therefore not a medical device and is not subject to the Medical Devices Regulations (SOR/98-282) under the Canadian Food and Drugs Act.
Readers Note:
This assessment was prepared by an independent Canadian regulatory audit and quality consulting firm. The firm concluded that, under Health Canada’s "Software as a Medical Device: Definition and Classification" guidance, MedAi meets the Table 1 exclusion criteria and is not a medical device subject to the Medical Devices Regulations (SOR/98‑282). This assessment is for informational purposes only. The opinions and views expressed herein are based on current interpretations of Canadian regulations and may change from time to time based on decisions and rulings that are known as of the date of the opinion or views expressed. Every attempt is made to apply interpretations appropriately and consistently based on information provided, past practices and previous decisions, rulings that are in the public domain or known to the consulting firm.