Draft Examples Document - Software as a Medical Device (SaMD)

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Organization: Health Canada

Published: 2019

This document is being distributed for comment purposes only.

Draft Date: 2019/01/23

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Table of Contents

1. Non-IVDD SaMD

1.1 Examples of Class I SaMD

1.2 Examples of Class II SaMD

1.3 Examples of Class III SaMD

2. IVDD SaMD

2.1 Examples of Class II IVDD SaMD

2.2 Examples of Class III IVDD SaMD

3. Software that is not subject to the Regulations

It is Health Canada’s current position that the software examples below do not meet the definition of a device as outlined in the Food and Drugs Act and therefore, are not subject to the Regulations.

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2019-01-24