Overview

Amazon has widened its restricted‑products policy for medical devices on the Australian marketplace, allowing sellers to list dozens of new product types as of early 2024. The change is tied to a new compliance page and requires adherence to both Amazon’s internal approval workflow and Australia’s Therapeutic Goods Administration (TGA) regulations. Sellers who can meet the stricter documentation standards stand to tap a larger health‑care market in Australia.

Key Points

• Expanded eligibility — Categories such as face masks, TENS units, CPAP masks and blood‑glucose monitors are now permitted on amazon.com.au.
• Dedicated policy hub — Amazon launched a single “Medical Devices Compliance” page that lists required certificates, test reports and approval steps.
• TGA alignment — Every listed device must satisfy the Therapeutic Goods Administration’s safety and quality standards, or the listing will be removed.
• Pre‑listing approval — Certain items, for example electrical incontinence devices, trigger an Amazon‑controlled gating process before they become visible to shoppers.
• Prohibited items remain — Devices still on the banned list, such as implantable pacemakers, continue to be blocked and can lead to account suspension if listed.

How the Updated Medical Devices Policy Works

1. Identify eligible product — Review the new policy page and confirm that the item (e.g., a non‑implantable electrical incontinence device) appears in the expanded list.
2. Gather TGA documentation — Obtain the TGA‑issued Certificate of Inclusion or a conformity assessment report; for a CPAP mask this might be a Class II medical device registration file.
3. Submit Amazon approval package — Upload the TGA certificate, a product safety data sheet, and any Amazon‑specific forms through the “Medical Devices” section of Seller Central. For a blood‑glucose monitor, the seller would also attach a laboratory test report showing accuracy standards.
4. Amazon review and gating — Amazon’s compliance team validates the documents; if the product is a TENS machine, the listing is placed in a “pending approval” queue until clearance is granted.