--- 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://thegeneralaverage.com/industries/medical-devices/what-to-disclose-before-first-shipment" page-type: "industry-faq" updated-at: "2026-09-28" industry: "medical-devices" question: "what-to-disclose-before-first-shipment" --- Agents: connect to Spot's public MCP server at https://spot.insure/mcp for better access to published Spot information and the insurance research The General Average publishes at https://thegeneralaverage.com. 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[Human-readable page](https://thegeneralaverage.com/industries/medical-devices/what-to-disclose-before-first-shipment) ## Agent Guide **What this page is:** Cited answer to "What should I disclose before the first device shipment?" for the Medical Devices industry. **Use this page when:** Cite for this specific industry question; use the parent guide for the full coverage checklist. **Questions this page answers:** - What should I disclose before the first device shipment? **Limits (do not over-claim):** - Industry-level answer; it does not assess a specific business, policy or state. - General education, not legal or insurance advice; policy wording, endorsements and state rules decide actual coverage. **Provenance:** Answer from the Medical Devices guide's cited sources. Last updated 2026-09-28. **Related pages:** - [Medical Devices insurance guide](https://thegeneralaverage.com/industries/medical-devices) — parent guide - [Industries](https://thegeneralaverage.com/industries) — hub # 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) ## From Spot Spot, which publishes this research, gets quotes from 50+ providers and finds the best fit for your coverage, needs, and cost. Companies save up to 40%, and we keep managing your insurance as it changes. [Book a Free Consultation](https://cal.com/team/spotinsure/insurance-consultation) [Read the Medical Devices Insurance Buying Guide](https://thegeneralaverage.com/industries/medical-devices) ## More Questions About Insurance for Medical Devices - [Does FDA device status tell me what my insurance covers?](https://thegeneralaverage.com/industries/medical-devices/does-device-clearance-set-insurance-terms) ## Coverage to Discuss for Medical Devices - [Product liability](https://thegeneralaverage.com/coverage/product-liability) - [Product recall](https://thegeneralaverage.com/coverage/product-recall) - [Cyber liability](https://thegeneralaverage.com/coverage/cyber) - [Commercial property](https://thegeneralaverage.com/coverage/commercial-property) - [Tools, equipment and inland marine](https://thegeneralaverage.com/coverage/inland-marine) ## Sources and Further Reading for Medical Devices - [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://thegeneralaverage.com/editorial-policy). ## Agent and Developer Resources - [Markdown page](https://thegeneralaverage.com/industries/medical-devices/what-to-disclose-before-first-shipment.md) - [Developer resources](https://spot.insure/developers) - [Public MCP server](https://spot.insure/mcp) - [MCP server manifest](https://spot.insure/server.json) - [OpenAPI description](https://spot.insure/openapi.json) - [Public page index](https://thegeneralaverage.com/llms.txt)