Consultation: Guidance on clinical evidence requirement for medical devices

From Health Canada

Current status: Open

Opened on November 03, 2021 and will close to new input on February 01, 2022.

Health Canada is pleased to announce the development of the draft Guidance on clinical evidence requirements for medical devices and its companion piece which provides manufacturers a list of examples to consider. This guidance document is the result of a commitment under the Medical Devices Action Plan to improve the safety and effectiveness of medical devices and how they get to the Canadian market.

This consultation contains two documents:

  1. Guidance on clinical evidence requirements for medical devices
  2. Companion document: Examples of clinical evidence requirements for medical devices

Join in: how to participate

  1. Review the above guidance and companion documents.
  2. Make yourself heard by sending an email to hc.meddevices-instrumentsmed.sc@hc-sc.gc.ca with your ideas or comments.

Who is the focus of this consultation

We seek to engage with medical device stakeholders, primarily:

Key questions for discussion

Health Canada invites you to participate by providing feedback with respect to the Guidance on clinical evidence requirements of medical devices and its companion piece.

Your feedback is sought regarding the overall clarity and content of the draft guidance document, as well as on the examples provided in the guidance's companion piece. Specifically, we would like to receive comments from medical device stakeholders on the following aspects of the documents:

The input gathered through this process will be used to finalize the guidance document. The feedback will allow Health Canada to further clarify how it considers the use of clinical evidence to review the safety and effectiveness of a medical device.

Related information

Contact us

Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa, ON K1A 0K9
Email: hc.meddevices-instrumentsmed.sc@hc-sc.gc..ca

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