High‑risk (Class III‑type) medical devices are effectively treated as prohibited on Amazon unless you secure explicit category approval backed by full regulatory evidence. Unlike Class I/II, these devices require an FDA Premarket Approval (PMA) decision, not just a 510(k) clearance, plus FDA establishment registration and device listing that match the exact brand and model.
Amazon typically expects: the PMA approval letter or summary, proof of FDA establishment registration and device listing, clinical or technical summaries supporting safety and effectiveness, and compliant labeling/UDI and quality‑system evidence (for example, ISO 13485). If this package is not already on file in Amazon’s internal compliance review and the ASIN is mapped to a high‑risk medical taxonomy node, the listing is usually auto‑suppressed before or shortly after launch.
Appeals submitted through standard seller support rarely succeed unless they are routed through a specialized medical/healthcare program or managed account team that is authorized to review PMA‑level documentation and override default blocks
