Compliance
Every PolyMedica pack is registered with the Therapeutic Goods Administration, manufactured to AS 5369:2023, sterilised by ethylene oxide, and traceable from REF and lot to expiry. Compliance evidence is part of the product, not an afterthought.
ARTG Registry
PolyMedica products supplied in Australia are listed on the Australian Register of Therapeutic Goods.
AS 5369:2023 — the standard that changed reprocessing
AS 5369:2023 sets the requirements for reprocessing reusable medical devices in Australian healthcare settings. It tightened the bar on validation, documentation, and audit obligations for any practice that autoclaves instruments on site.
For a high-volume excision practice, that means real cost — not just an autoclave, but validated cycles, biological indicators, traceable load records, and documented training.
PolyMedica is single-use by design. There's nothing to reprocess. Compliance is in the box.
Manufactured to spec. Documented end to end.
Surgical instruments — 316 surgical-grade stainless steel, the same alloy specification used in operating-theatre reusables. Manufactured to PolyMedica specification in an ISO 13485-certified facility. REF MB-01-1013.
Bagasse procedure tray — sugarcane-fibre tray. Compostable substrate; structural rigidity matched to clinical use.
Sterile fenestrated drape — 45 × 45cm fenestrated drape with 2 / 4 / 6 / 10mm concentric margin ellipses. Margin standards aligned with Australian guidance.
Sterilisation — ethylene oxide (EO) sterilisation, validated process. Sterility maintained to listed expiry.
Sealed perforated pouch — tamper-evident sealed header pouch with tear perforation. Pouch graphics carry REF, lot, expiry, and ARTG references on every unit.
Bed roll & paper — PolyMedica paper products manufactured to specification. ARTG-listed bed roll. Toilet roll supplied as non-therapeutic consumable.
Traceable to the lot
Every pack carries a REF, a lot number, and an expiry — printed on the pouch and recoverable from the ARTG record.
- REF — MB-01-1013 (Skin Excision Pack family)
- Lot — varies per production run, printed on every pouch
- Expiry — sterility-validated shelf life, room temperature storage
- Sterile EO — single-use, do not re-sterilise
Audit-ready documents on request
- ARTG inclusion certificates per active SKU
- EO sterilisation validation per production run
- ISO 13485 manufacturing evidence
- AS 5369:2023 single-use rationale (practice handout)
- Material safety & component disclosure per pack
- RACGP 6th edition alignment brief