Medical device warehouse software: lots, holds and the records a recall needs
Manufacturers, importers and distributors covered by Medical Devices Regulations ss. 52–56 keep distribution records sufficient for a rapid recall, for the longer of the device’s projected useful life or two years after shipment. Plan the required recipient reporting with the licence holder before accepting stock.
Health Canada exempts a warehouse that only stores devices from its own MDEL when it does not buy, sell or take them on consignment; the licence holder identifies buildings where its procedures apply. WarePulse records lots and expiry on every plan but does not provide end-to-end unit-level serial inventory tracking.
Connect workflow fit to rollout context earlier.
Health Canada exempts a warehouse that only stores devices from its own MDEL when it does not buy, sell or take them on consignment; the licence holder identifies buildings where its procedures apply. WarePulse records lots and expiry on every plan but does not provide end-to-end unit-level serial inventory tracking.
Third-party warehouses on every plan storing Class I to IV devices for MDEL holders.
Distributors whose recalls are traced by lot rather than by individual serial number.
Warehouses that want receipts checked against the expected quantity and suspect stock held with a recorded reason.
Keep the next commercial step visible.
Move from this page into pricing or implementation without losing the next step.
ImplementationCompare related WarePulse options
Compare the next topics buyers usually review: implementation, pricing, trust, field evidence, and operating fit.
Plan the next warehouse step
Bring one client’s device list with its lot formats and retention periods, and we will show what WarePulse records per lot and what a recall list would still need.
Workflow steps
- Ship one lot to three customers, check that each pick line records the lot, then ask how the recipient list would be produced.
- Place a lot on hold for a complaint and confirm it drops out of available stock.
- Check with each client which of its devices, if any, must be traced by serial number.
Implementation planning
- SOR/2026-110 was registered June 4, 2026 and takes effect December 1, 2026. It makes documented-procedure duties explicit, including applicable handling and storage procedures for Class II to IV devices. Confirm each licence holder’s preparation.
- Items import from CSV with their lot and expiry tracking settings, and opening stock imports with lot numbers and expiry dates.
- Agree with each licence holder how a recipient list will be produced, since there is no built-in recall report.
Security and purchasing context
- Holds and releases are limited to managers; roles run from owner and admin to manager, operator and picker.
- On every plan, each licence holder’s portal login sees only its own inventory and receipts.
- Validate each required record type and its retention against the device’s useful life, including records held outside WarePulse.
Questions to resolve
- Does our warehouse need its own MDEL? Not if it only stores; the licence holder may list your building.
- Can WarePulse trace individual serial numbers? No; it traces lots.
Expected business impact
- Recorded lot references can support a recipient-report project; test that report against the licence holder’s required recipients, quantities, dates and retention before use.
- Quantity holds exclude the held available stock from new allocation; existing reservations and other locations require separate review.
The sector rules your WMS has to respect
The operating rules that create the most risk in this sector — and hurt the most when the software gets them wrong.
Distribution records (MDR ss. 52–56): kept by manufacturers, importers and distributors, sufficient for a complete and rapid recall, retained for the longer of the device’s useful life or two years after shipment and retrievable in a timely way.
For a manufacturer- or importer-initiated recall not ordered by the Minister, MDR s. 64 requires the prescribed written information by the start of the recall, including affected quantities and recipients.
Complaints (ss. 57–58): records of reported problems and the actions taken, with documented procedures for investigation and recall.
Establishment licensing (s. 44 and GUI-0016): importers and distributors need an MDEL; a storage-only warehouse is exempt but may be listed as a building where the licence holder’s procedures are in place.
Health Canada consulted on Canadian UDI in 2021; verify current device-specific requirements. US UDI applies to most devices with exceptions and alternatives; required production identifiers vary by device.
Where WarePulse fits this sector
How WarePulse handles the sector rules that actually matter on your floor.
All plans store lot and expiry references in receiving, stock, picking and transfers. These are inputs to a trace investigation; there is no built-in recipient or recall report, and its completeness must be validated separately.
Receiving rejects quantities above an established expected receipt. Direct receipt into quarantine depends on the supported authorized workflow; confirm that flow separately from mobile receiving.
Authorized managers can hold available quantity by item, lot and location with a recall or investigation reason. Review other locations, reservations and shipments separately; this is not a global recall stop.
Inventory CSV exports include quantities by SKU and location. Audit records support review of recorded operations; validate record coverage and retention against the device’s useful life rather than treating a log policy as regulatory compliance.
On every plan, the licence holder gets a client portal with its own inventory, receipts and proof of delivery.
WarePulse tracks lots, not individual serial numbers; devices that must be traced unit by unit need a serial-capable system.
Built for warehouses in this industry
Operators and customer profiles where sector-specific rules shape the decision.
Third-party warehouses on every plan storing Class I to IV devices for MDEL holders.
Distributors whose recalls are traced by lot rather than by individual serial number.
Warehouses that want receipts checked against the expected quantity and suspect stock held with a recorded reason.
Not a fit where implants or other devices must be tracked by unique serial number.
The recall report decides the warehouse record
Section 64 asks for quantities and recipients on the day a recall begins. Work backwards from that: every shipment needs the lot, the customer, the date and the quantity attached when it leaves, and the record has to survive as long as the device’s useful life. Decide how the recipient list will be produced before the first recall, not during it.
Record lot, customer, date and quantity on every outbound shipment.
Confirm the retention period each client sets from its devices’ projected useful life.
Decide who can release a lot from hold and how that is recorded.
Ask each vendor to produce a recipient list by lot from a real week of shipments.
Where to go next
Pharma and expiry operations
The adjacent page on expiry-driven, traceability-heavy stock.
See detailsAudit logs
How write-once audit entries record who changed what, and when.
See detailsFeature hub
Review barcode, lot, billing, and portal capabilities.
See detailsWorkflow hub
Connect the sector rule to the station that must change first.
See detailsComposite operating scenarios
Use disclosed composite scenarios to keep planning grounded in operations.
See detailsEcosystem data exchange
Review CSV, Next Movement, and scoped data handoffs that shape the sector flow.
See detailsPricing
Plans from $699 CAD a month for one warehouse, with unlimited users.
See detailsImplementation
Review the rollout path before the evaluation turns into a risky cutover.
See detailsFrequently asked questions
How long must medical device distribution records be kept in Canada?+
Does a third-party warehouse need an MDEL?+
Does Canada require UDI barcodes on medical devices?+
Can WarePulse track device serial numbers?+
Can WarePulse produce the recall recipient list?+
What does a recall report to Health Canada include?+
Anchor the evaluation to the hardest rule on your floor.
Start with the licence holder’s reporting requirements, then validate the records and extraction needed to meet them before stock arrives.
Plan the next evaluation step
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