Overview

Amazon mandates that every medical device sold on its marketplace be listed only as “New.” The rule applies to any product used for diagnosing, treating, or preventing disease in humans or animals, and non‑compliant listings can trigger removal or account penalties. Sellers in the health‑care space must align inventory, packaging, and approval processes with these strict standards to stay active on the platform.

Key Points

• New‑only policy — All medical devices must be offered in New condition; Amazon does not accept Used, Refurbished, or Open‑Box listings for this category.
• Broad product definition — The term “medical device” covers everything from home blood‑pressure cuffs to veterinary surgical tools, meaning the rule touches a wide array of SKUs.
• Original packaging requirement — Items must arrive in the manufacturer’s sealed box with every accessory, instruction sheet, and warranty card that originally shipped with the product.
• No signs of prior use — Any evidence of wear, tampering, or broken seals disqualifies a device from being listed, even if the item is still functional.
• Restricted‑product approval — Certain devices fall under Amazon’s restricted‑products program, so sellers may need explicit category approval before a listing can go live.
• Supply‑chain vigilance — Inventory sourced from liquidation pallets, returns bins, or secondary markets is likely to contain used or damaged units and therefore cannot be listed.
• Potential account consequences — Violations can lead to listing suppression, forced inventory removal, or suspension of the seller account, depending on the severity of the breach.

How Amazon’s Condition Requirements Work

1. Verification of packaging — The seller inspects each unit to confirm the box is unopened, the seal is intact, and all manufacturer‑included components are present; for example, a digital thermometer must include its protective plastic cover, battery, and user manual.
2. Assessment of device condition — The product is examined for any scratches, dents, or signs of previous handling; a pulse oximeter with a scuffed housing would be rejected at this stage.