Health Canada Medical Device & In Vitro Diagnostic Submissions

With all the regulation changes happening around the world, it can be hard to keep on top of all of them.

Beginning June 23, 2021, Health Canada now requires manufacturers and importers to notify HC of incidents (i.e., recalls, reassessments, suspensions of authorization) in writing within 72 hours. The applies even if the incident did not occur within Canada, but involves a device sold in Canada. The current regulation stipulates notification within 10-days.

Like the EU Medical Device Regulation (MDR), HC license holders are now required to prepare summary reports every 2 years for Class II devices or annually for Class III and Class IV devices. These summaries should include adverse effects, reported problems, incidents, and risks which can be used to assess the benefits and risks of the medical device. In preparing the document, if a change in the risk-benefit profile is identified, the manufacturer must notify HC in writing within 72 hours. This part of the regulation comes into force on December 23, 2021.

For more information, please see our blog on Canadian regulation changes: Expanded Canadian Regulatory Amendments.

Canadian Services

• Classification of your device.
• Identify the type of license needed (MDEL or MDL).
  • Determine the associated fees.
    • Determine if eligible for reduced fees.
  • Complete the application.
  • License renewals.
• QMS requirements.
• Identify changes that need to be reported.
  • Writing a license amendment application / fax-back form
  • Writing an annual report
• Identify missing testing or studies needed to maintain license.
• Assistance with incident reporting
• Developing SOP and templates or writing summary reports.