PHASE 3: REGULATION

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reg·u·la·tion

Before a product is authorized for sale in Canada, there must be evidence to support the safety, effectiveness and quality of a product for Health Canada approval. Health Canada regulates medical devices based on risk class (Class I: low risk, II, III,IV: highest risk). Class I devices do not require a licence under Health Canada. All Class II, III, and IV medical devices sold in Canada must have a valid medical device licence issued by Health Canada. Health Canada provides access to unlicensed medical devices through the Special Access Programme (SAP).

A product classified as either disruptive (having high impact) or non-disruptive (having incremental impact) will have different regulatory requirements. Disruptive innovations may fall under classes II-IV, while non-disruptive innovations typically fall under class I. Depending on device classification, an innovator may first choose to test and market a product under regulatory bodies in other jurisdictions (e.g., FDA in the United States; EU in Europe) before obtaining Health Canada approval. Review the FDA and EU regulatory requirements and device classifications as these differ from Health Canada. An innovator must consult these regulatory bodies before seeking approval in jurisdictions outside Canada.

A small Canadian market and public health care system may also pose challenges for market entry, and innovators may look to commercialize in other regions with larger markets (e.g., United States, Europe) before penetrating the Canadian market. It is important to consult with other jurisdictions when deciding to seek regulatory approval. Innovators should also seek grant funding by government and non-government agencies and to collaborate with experts across government, academia, health care, and industry to support trial design and testing.

Digital Health Solutions:
Health Canada is adapting its regulatory approach to include the review of digital health solutions to keep pace with innovation and advances in the medical device and digital health technology sector.  The newly formed Digital Health Review Division will review current and future digital health medical devices. For more information, see the Notice: Health Canada’s Approach to Digital Health Technologies.

 

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innovators checklist

  • Determine the Health Canada device classification (I-IV) of the product.

  • Consider other jurisdictions to generate clinical evidence and obtain regulatory approval for your product to later support requirements for uptake in Ontario.

  • Partner with a hospital or research organization to test the product and produce required evidence.

  • Collaborate with experts in government, academia, health care, and industry to support trial design and testing.

  • Determine whether the minimum required evidence has been collected to support the clinical utility of the product.

 

 

Last update: 2018-Nov-26

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