Consultation: Medical device meetings draft guidance document: Overview and associated documents

The purpose of this consultation was to engage with stakeholders on the Device Advice: Medical device meetings draft guidance document and associated documents.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.

Who was the focus of this consultation

We engaged with medical device stakeholders, primarily:

• manufacturers
• researchers
• investigators

Key issues discussed

The Device Advice: Medical Device Meetings Draft Guidance Document touched on the following issues:

• The overall clarity and content of:
  • the draft guidance document
  • the meeting request form
  • the record of decision templates
• These aspects of the draft guidance documents:
  • how to request a meeting
  • meeting types and their eligibility criteria
  • the meeting package requirements to support substantive discussions

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.

Contact us

Medical Devices Directorate
Health Products and Food Branch
Health Canada
Email: mddpolicy-politiquesdim@hc-sc.gc.ca