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Pre-Submission Meeting (PSM) — Practical Guide

This guide supplements the formal PSM page with practical advice on preparing for a successful meeting.

Before requesting a PSM​

Determine if a PSM is worthwhile. PSMs are most valuable when:

  • The device is novel or uses an emerging technology
  • You are uncertain about classification or regulatory pathway
  • You have questions about the level of clinical evidence required
  • The device is Class III or IV and involves complex safety issues
  • You are considering using a novel study design or foreign data

For straightforward Class II applications where the submission requirements are well-established, a PSM may not add value and may delay your timeline.

Preparing your PSM request​

A well-prepared PSM request leads to a more productive meeting. Include:

1. Device background​

Write a clear, concise device description (2–3 paragraphs maximum). Assume Health Canada has not seen your device before.

2. Questions — be specific​

Your questions should be specific and answerable. Avoid vague questions like "What do you need from us?" Instead:

  • "Is our proposed clinical evidence package (consisting of X, Y, Z studies) sufficient for a Class III application?"
  • "Does Health Canada consider our device to be Class II under Rule 4, or Class III under Rule 5, given that..."
  • "Would Health Canada accept a European notified body audit certificate in lieu of MDSAP for our initial submission?"

3. Background documents​

Attach only what is necessary for Health Canada to answer your questions. A detailed device description, draft intended use statement, and outline of your proposed evidence package is usually sufficient.

During the meeting​

  • Take notes — PSM guidance is provided verbally and in a written summary, but capturing detail in the meeting is valuable
  • Ask for clarification if any guidance is unclear
  • Don't commit to things in the meeting that you haven't confirmed internally

After the meeting​

Health Canada provides a written meeting summary typically within 30 days. Review it carefully and flag any discrepancies with your own notes promptly (within 30 days) — after that window, the summary is considered final.

The PSM summary is not legally binding, but departing significantly from it in your submission will require explanation.