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Reclassification

Overview​

Device classification is not permanent. Health Canada may initiate a reclassification when new evidence changes the risk profile of a device category. Manufacturers may also request reclassification if they believe their device has been misclassified.

Manufacturer-requested reclassification​

A manufacturer who believes their device is classified too high (or too low) may request a formal classification ruling from Health Canada's Medical Devices Directorate.

The request should include:

  • Full description of the device and its intended use
  • The current classification and the basis for the current classification
  • The proposed classification and the regulatory basis (specific rules in Schedule 2)
  • Supporting data where relevant

Health Canada reviews the request and issues a formal ruling. If the manufacturer disagrees with the ruling, they may escalate through Health Canada's review processes.

Health Canada-initiated reclassification​

Health Canada may reclassify a device category when:

  • Post-market surveillance identifies a higher (or lower) risk profile than originally classified
  • New clinical evidence changes the understanding of device risks
  • International regulatory authorities have reclassified comparable products
  • An advisory committee recommends reclassification

Health Canada publishes proposed reclassifications for public consultation before implementing regulatory changes.

Impact of reclassification​

If a device is reclassified to a higher class, manufacturers holding existing licences may need to:

  • Submit additional safety and effectiveness evidence
  • Obtain an MDSAP audit certificate if not already held
  • Pay additional application fees

If a device is reclassified to a lower class, manufacturers may benefit from reduced regulatory requirements, but must still meet all requirements applicable to the new class.

Recent reclassifications​

Health Canada publishes proposed and completed reclassification actions in the Canada Gazette and on the Health Canada website. See Recent Amendments for the current status of reclassification activities.

Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 2; s 20 (applications to vary classification)