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Distribution Records

Why distribution records matter​

Distribution records are the backbone of an effective recall system. Without accurate distribution records, it is impossible to identify and contact all customers who received a recalled device. Health Canada regularly cites inadequate distribution records as a contributing factor in poor recall execution.

Who must maintain distribution records​

  • Manufacturers of Class II–IV devices
  • Importers of any class of device
  • Distributors of any class of device

What must be recorded​

Incoming (receipt) records​

For each shipment received:

  • Device name and description
  • Model/catalogue number
  • Lot/serial number(s)
  • Quantity received
  • Date of receipt
  • Name and address of the supplier

Outgoing (distribution) records​

For each shipment distributed:

  • Device name and description
  • Model/catalogue number
  • Lot/serial number(s)
  • Quantity distributed
  • Date of distribution
  • Name and address of the customer (must enable contacting the customer directly)

Record retention period​

Distribution records must be retained for:

  • The expected lifetime of the device, or
  • 2 years after the last distribution of a lot, whichever is longer.

For long-term implants, this can mean records must be retained for 10–15 years or more.

Electronic records​

Distribution records may be maintained electronically. Electronic records must be:

  • Backed up regularly
  • Protected from unauthorised modification
  • Retrievable and legible for the required retention period

Health Canada inspection​

Distribution records are routinely inspected by Health Canada during MDEL inspections. Inspectors will typically request records for a sample of lots and verify that the records are adequate to support a recall.

Legislative source: Medical Devices Regulations, SOR/98-282, ss 58–65