Distribution Records
The obligation
All licensed dealers (importers and wholesalers) are required to maintain distribution records for the medical devices they deal in. This requirement is part of Good Distribution Practice (GDP) compliance.
What must be recorded
Distribution records must contain sufficient information to allow full traceability of devices — i.e. to identify which devices (by lot/batch number and quantity) were supplied to which customers, and when. Specifically:
- Device name, model number, and registration number;
- Lot or batch number (or serial number for individually serialised devices);
- Quantity supplied;
- Date of supply;
- Name and contact details of the customer (hospital, clinic, distributor);
- Invoice or delivery order reference.
Why distribution records matter
Distribution records are the critical tool for executing an FSCA or recall. Without complete distribution records, a company cannot:
- Identify which customers received potentially affected devices;
- Contact those customers with a Field Safety Notice;
- Confirm that all affected devices have been retrieved or accounted for.
Incomplete distribution records discovered during an FSCA significantly complicate and delay the corrective action, and are a serious GDP non-compliance.
Retention period
Distribution records must be retained for a period that allows for the traceability obligations to be met throughout the expected life of the device. HSA's GDP guidance specifies minimum retention periods — always verify the current requirement in the applicable guidance document.