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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 full traceability obligations to be met throughout the expected clinical lifetime of the device, or until the device is recalled or withdrawn from the market, whichever is longer. HSA's GDP guidance specifies minimum retention periods — always verify the current requirement in the applicable guidance document.

Official sources​

Distribution records must be retained for a minimum of [X years] after the device is placed on the market, or for the expected lifetime of the device, whichever is longer. Refer to HSA's Good Distribution Practice (GDP) guidance for devices with extended clinical use periods. Verify the current requirement in the applicable HSA guidance document at hsa.gov.sg/medical-devices/gdp-guidance