Feb 3, 2021

Health Canada (HC) published an updated guidance document, Amendments to the Food and Drugs Act: Guide to New Authorities, highlighting the new powers given to the Canadian Minister of Health to require medical device license holders to perform assessments, tests, or studies on their products. As with the recently amended regulations for post-market surveillance in the country, these powers derive from the stronger safety measures introduced to the drug and medical device sectors in 2014 by Vanessa’s Law.

The document, which will become effective on June 23 of this year, is intended to set out guiding principles and increase consistency and predictability for HC, industry stakeholders, and others on how decisions and requirements from the Minister will be applied when a safety issue is identified. The Minister can impose these powers whenever new information becomes available affecting the risk and/or benefit of a device, or when there is a need to manage uncertainties associated with a device. The guide also specifies that the Minister has the power to enable the public release of certain information regarding therapeutic products, including clinical information in medical device applications.

New powers of Minister of Health and how to use them

The following powers of the Minister of Health are enumerated in the guidance document:

  • Requesting and disclosing information
  • Ordering label changes and package modifications
  • Issuing recalls of therapeutic products
  • Calling for a product assessment
  • Calling for tests, studies, or monitoring of products

Each section answers questions about who is authorized to use a power, to whom and what it applies, scope and threshold of the power, considerations and actions to be taken before use, correct form and procedure for use of a power, and follow-up activities. Two annexes to the document address elements for determining whether a product constitutes a serious risk and standards for what constitutes “sufficient notice” in notifications to affected parties.

Related Health Canada medical device regulatory information from Emergo by UL:

Author

  • Timothy Herr

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