Consultation: Medical device meetings draft guidance document: Overview and associated documents
Current status: Open
Opened on November 24, 2021 and will close to new input on February 22, 2022.
Health Canada is pleased to announce the development of the Device Advice: Medical device meetings draft guidance document and associated documents. This guidance document is the result of a commitment to develop and implement processes that facilitate effective communication between medical device manufacturers and Health Canada.
Join in: how to participate
- Review the following Device Advice Medical device meetings documents:
- Medical device meetings draft guidance document:
- Device advice - Meeting request form (Please download the PDF to your computer and make sure to click "Enable all features". This will allow you to view and use the form correctly.)
- Send an email to email@example.com with your ideas or comments to make yourself heard.
Who is the focus of this consultation
We will engage with medical device stakeholders, primarily:
Key questions for discussion
Health Canada would like you to participate by providing feedback with respect to the Device Advice: Medical Device Meetings Draft Guidance Document.
Your feedback is sought regarding the overall clarity and content of the draft guidance document, the meeting request form and the records of decision templates. Specifically, we would like to receive comments from medical device stakeholders on the following aspects of the documents:
- How to request a meeting
- Meeting types and their eligibility criteria
- The meeting package requirements to support substantive discussions
We are also requesting that you test the meeting request form by sending mock content to help determine if adjustments are necessary to the form.
The input gathered through this process will be used to finalize the guidance document and the related content. The feedback will:
- enable Health Canada to design a process that captures all the required information such that HC and the requester can have a productive meeting; and
- give Health Canada the opportunity to test out the process.
- Food and Drug Act
- Medical Device Regulations
- Device advice for medical devices
- Notice: Device Advice: Health Canada launching a new pilot project to formalise a framework aimed at offering regulatory advice to medical device manufacturers
Medical Devices Directorate
Health Products and Food Branch
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa, ON K1A 0K9
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