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Pre-Submission Meetings (PSM)

What is a Pre-Submission Meeting?​

A Pre-Submission Meeting (PSM) is an informal meeting between a manufacturer and Health Canada's Medical Devices Directorate to discuss regulatory questions before a Device Licence or ITA application is filed.

PSMs are particularly valuable for:

  • Novel technologies with an unclear regulatory pathway
  • Complex or high-risk devices (Class III or IV)
  • Devices with unusual intended uses
  • Questions about classification
  • Clarification of evidence requirements for clinical data
  • Combination products (drug-device)
  • SaMD and AI/ML-based devices

Benefits of a PSM​

Early engagement with Health Canada through a PSM can:

  • Clarify the regulatory pathway before significant investment is committed
  • Identify what evidence will be required, allowing study designs to be optimised
  • Prevent late-stage surprises that delay submission or approval
  • Build a relationship with the assigned reviewer

How to request a PSM​

PSM requests are submitted to Health Canada's Medical Devices Directorate via the Health Canada e-Submission portal (HRES). The request should include:

  1. Device description — brief description of the device and its intended use
  2. Questions for discussion — a specific list of questions the applicant wants addressed
  3. Background information — any relevant technical data, study designs, or preliminary results that would help Health Canada prepare for the meeting
  4. Proposed format — teleconference, videoconference, or in-person meeting

PSM process​

  1. Submit PSM request via HRES
  2. Health Canada reviews the request and confirms the meeting (typically within 30–60 days for non-urgent requests)
  3. Meeting is held — discussion is informal and non-binding
  4. Health Canada provides a written summary of meeting outcomes
  5. Manufacturer proceeds with application development based on the guidance received

Limitations of PSM guidance​

PSM guidance is informal and non-binding. Health Canada may reach different conclusions during a formal application review. However, PSM guidance is generally consistent with formal review positions, and significant departures are uncommon.

Other pre-submission interactions​

In addition to PSMs, manufacturers can interact with Health Canada through:

  • Written enquiries to the Medical Devices Directorate
  • Industry consultation sessions on guidance documents
  • IMDRF working group participation

Official resource: Health Canada — Pre-submission meetings