The four constraints that shape your choice.

Most medical devices brands don't lose on pick rate — they lose because the 3PL isn't built for the operational shape of the category.

TGA / ARTG compliance

Class I and II medical devices require ARTG entry. Your 3PL doesn't manage your registration but must hold the documentation that proves your devices are stored and shipped to TGA standards.

GDP / GMP alignment

Good Distribution Practice for medical devices (TGA Code of GMP for Therapeutic Goods, where applicable) requires temperature monitoring, calibrated equipment, controlled access and documented procedures.

Lot-level traceability

Every device shipment must be traceable to lot, customer and date. Recall must be executable in 24 hours.

Sterile vs non-sterile zones

Sterile devices need separate handling and storage. Some 3PLs have sterile cleanrooms; most don't.

What you should be paying.

Medical device 3PL pricing runs 25–60% above standard ambient because of compliance overhead and dedicated qualified staff. Storage is on the higher end of the city range. Pick & pack often quoted hourly for low-volume / high-mix medical brands rather than per-pick.

What we see in medical devices audits: Medical device brands often try to use general retail 3PLs to save cost. The economics work until the first TGA audit, batch issue, or recall — at which point the gap becomes catastrophic.

Get matched with medical devices 3PLs that already serve the category.

Send us your volume, channels, and product specifics. We'll introduce you to vetted AU 3PLs that have actually served medical devices brands at your stage.

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What to look for.

  • TGA-aware operations with documented Quality Management System
  • GDP / GMP alignment with audit history (ask for it)
  • Calibrated temperature monitoring with documented response protocol
  • Lot-level traceability tested in a recall drill within 12 months
  • Sterile zone capability if your range includes sterile devices

What to walk away from

Avoid 3PLs that imply 'we can handle medical' without showing the Quality Management System. The first TGA audit reveals gaps that can suspend your supply.

"Medical device 3PL is a regulated relationship, not a commercial one. Choose the partner with the QMS, not the lowest pick rate."

Sources. 3PL Compare audit set + AU regulatory references (TGA, GS1, ADG/IATA, HACCP) where applicable. Pricing reflects observed averages across the relevant subset of our audit data, not a fixed quote.
Cite this page as: 3PL Compare. (2026). 3PL for medical devices. Retrieved from https://3plcompare.com.au/3pl-for-medical-devices