Health Canada Clarifies Software Regulation

Health Canada published a notice entitled “Software Regulated as a Class I or Class II Medical device,” along with a Q&A memo to clarify what software is regulated and which regulations apply. Both documents are included at the link provided. The notice appears to indicate that any software which fits the definition of a medical device based on intended use should conform to Health Canada requirements for establishment licensing of the firm (for Class I devices) and also licensing of the specific product (for Class II devices). The Q&A appears to indicate that Electronic Medical Records which only provide basic information and do not make decisions are not regulated as devices. Similarly, middleware used only to transport information is not regulated as a device. Application Service Providers (unless they provide a medical service themselves) are also not to be regulated.

Health Canada MD Notice Software – including Q & A

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