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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. Health Canada provides written guidance based on the meeting discussion within 15–20 business days of the meeting date. Manufacturers proceed with application development informed by this guidance, with the option to request a follow-up meeting if further clarification is needed.

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