---
title: "What should I disclose before the first device shipment?"
description: "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."
canonical: "https://spot.insure/industries/medical-devices/what-to-disclose-before-first-shipment"
page-type: "industry-faq"
updated-at: "2026-09-28"
---

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[Human-readable page](https://spot.insure/industries/medical-devices/what-to-disclose-before-first-shipment)

# 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. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm)

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. [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm)

## Need Help Choosing Coverage?

Spot prepares your applications, coordinates with brokers, and helps you compare quotes so you can choose coverage with the key details in front of you.

[Book a Free Consultation](https://cal.com/team/spotinsure/insurance-consultation)

[Read the Medical Devices Insurance Buying Guide](https://spot.insure/industries/medical-devices)

## More Medical Devices Questions

- [Does FDA device status tell me what my insurance covers?](https://spot.insure/industries/medical-devices/does-device-clearance-set-insurance-terms)

## Coverage to Discuss

- [Product liability](https://spot.insure/coverage/product-liability)
- [Product recall](https://spot.insure/coverage/product-recall)
- [Cyber liability](https://spot.insure/coverage/cyber)
- [Commercial property](https://spot.insure/coverage/commercial-property)
- [Tools, equipment and inland marine](https://spot.insure/coverage/inland-marine)

## Sources and Further Reading

- [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/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.
- [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-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.
- [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm) — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification
- [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts
- [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) — 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.
- [Small Business Insurance](https://content.naic.org/consumer/small-business.htm) — 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](https://spot.insure/editorial-policy).

## Agent and Developer Resources

- [Markdown page](https://spot.insure/industries/medical-devices/what-to-disclose-before-first-shipment.md)
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- [Public MCP server](https://spot.insure/mcp)
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