What should I disclose before the first device shipment?

Before the first shipment, give the broker the device’s intended use, manufacturer and distributor roles, territory, and destination; add contract, installation, service, and transit details when they apply.[1][5]

For devices or tools traveling to customers, ask which items, destinations, handlers, and trip stages are listed. California’s commercial guide treats movable property as distinct from property at a fixed site.[5]

Read the Medical Devices Insurance Buying Guide

Sources and Further Reading

  1. Quality Management System Regulation (QMSR) — U.S. Food and Drug Administration. Effective-date statement; Applicability of the QMSR; CGMP Exemptions

    Confirm the stated finished-device manufacturer scope when describing your product stage; it does not determine insurance response.

  2. Overview of IVD Regulation — U.S. Food and Drug Administration. IVD definition and classification sections; FDA notes the overview is nonbinding

    Describe an in-vitro diagnostic product and its intended use when it is part of your device.

  3. Cybersecurity — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification
  4. Cyber Insurance: Cybersecurity for Small Business — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts
  5. Commercial Insurance Guide — California Department of Insurance. Commercial property; inland marine; boiler and machinery; commercial general liability

    Review California guidance on business property, liability, and movable property; compare it with the policy form.

  6. Small Business Insurance — National Association of Insurance Commissioners. General liability, products, and other business liability sections

Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.

Updated 2026-09-28. Editorial Policy

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