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Regulatory and Quality

Medtech Canada offers various opportunities for its members to collaborate both with each other as well as engage with Health Canada.  We do so via:

  • Internal Committees
  • External associations/Network
  • Training seminars/webinars
  • One on One engagement with Medtech Canada personnel

Internal Committees/ External associations:

  • Committees (Internal)
    • Regulatory Affairs Committee (and subcommittees)
    • Based on Provincial and Federal government sectors
    • Based on specific ongoing target Topics 
    • Task forces (short term topics/projects)
  • Associations (External)
    • International (IMDRF/AdvaMed)
    • National (CSA)

Regulatory and Quality Assurance Committees:

  • Regulatory Affairs committee
  • Regulatory Sub-committees
    • Cost Recovery and Health Canada Performance
    • Pre Market Licencing
    • Post Market Surveillance
    • Quality Assurance 
    • Education / Training

Training/ Seminars:

  • Health Canada hosted Webinars
  • Speakers relating to focus areas of concern
  • Medtech Regulatory & Quality Conference and workshops

One on One Engagement and guidance documents:

Upon occasion our members request support and guidance around emerging and existing concerns.  Medtech Canada supports its members by providing feedback (non-consulting) as well as engaging Health Canada and other Government agencies as needed in order to provide the support for our members.

Examples of documents published to support our members include:

  • Best practices for contaminated returns
  • Licensing tools
  • High level guidance on medical device regulations
  • Ongoing reports from Health Canada on Medical Devices Bureau (MDB) Performance