Medical Device Insurance
Product liability, PI, recall and supporting covers matched to the device, its regulatory stage, the supply chain and the countries involved - from prototypes to $20M retail-mandated programmes.
$20M
Limits placed
Pre-revenue
To commercial
Specialist
Market access
Recognition
The Tank take
Medical device businesses usually need products and public liability as the anchor cover, with professional indemnity, recall, cyber, property and management liability considered according to their design work, services, data and company structure.
Classification, regulatory pathway, testing, intended use, quality systems, traceability, manufacturer contracts and overseas distribution all affect insurer appetite. ARTG inclusion or another regulatory status is evidence for the submission - it is not a guarantee of insurance.
The device journey decides the questions
Underwriters follow the device from intended use through design, manufacture, supply, use, complaint and recall.
The clinical consequence of failure and the product's regulatory classification drive severity. A wellness wearable and an implantable device may share components and sit in different underwriting worlds.
Prototype, validation, trial, pre-market and commercial devices each need a different testing and revenue narrative. Pre-revenue does not mean uninsurable - see our guide to pre-revenue device insurance.
Brand ownership, outsourced manufacture, supplier insurance and rights of recourse determine who actually carries a loss. Weak recourse against an overseas manufacturer makes the local entity the practical target.
Direct-to-consumer sales, hospital channels, vulnerable users and USA exposure can materially change pricing and terms. Battery-powered products sold direct to consumers attract particular scrutiny.
The sections a device business should test
The correct structure depends on declared activities and the definitions, exclusions and endorsements, not the policy title.
Core sections to anchor
- Products liability for bodily injury or property damage from supplied devices
- Public liability for premises, demonstrations and operational exposures
- Professional indemnity where design, specification, validation or training is provided
- Property and stock cover for tooling, inventory and laboratory assets
Specialist extensions to assess
- Product recall - normally a separate extension with its own trigger and sublimit
- R&D restoration for research assets lost to an insured event
- Cyber for connected devices, apps and health data
- Management liability and D&O for investor-backed companies
Recall, loss mitigation and R&D restoration are options with their own triggers, sublimits and exclusions. They should be requested and priced deliberately, not assumed from a life sciences policy title.
Complex science deserves a precise submission
Tell us what you advise on, build, test, supply or operate. We take the risk to insurers with genuine life sciences appetite and explain the terms before you decide.
Product liability placements from Tank's book
Anonymised examples showing how stage, channel and severity shaped real outcomes.
A metro Sydney importer of children's mealtime goods needed $20M combined public and products liability because retailers required it before listing. The main market panel declined; the submission documented compliance with Australian mandatory safety standards and the supply chain.
The result: $20M Public and Product Liability placed through a specialist underwriter at around $1,200 annual premium.
A maternity support business hired low-voltage therapeutic devices to expectant clients. The hire-and-reward model combined with imported medical devices sat outside mainstream appetite.
The result: Public and products liability on the hired devices placed through a specialist underwriter at around $2,800 annual premium.
An importer sold a small volume of own-brand camera and monitor systems direct to consumers. Lithium and button batteries, compliance testing still underway and direct-to-consumer sales meant low turnover did not translate into a low premium. One specialist market quoted with batch-testing and recourse conditions; others found the required exclusions made their terms uncompetitive.
The result: A placeable but expensive risk: severity, distribution model and controls mattered more than turnover. The client could then make an informed launch decision.
Premiums and outcomes described are specific to each client, anonymised and rounded. Your own terms will depend on your circumstances and the insurer.
The questions a device submission must answer
- 01
What is the product's intended use, class and current regulatory status?
- 02
How has it been tested, validated and quality controlled?
- 03
Who owns the design, brand, specification and regulatory file?
- 04
How are batches or serial numbers traced and complaints escalated?
- 05
What recall plan and adverse-event process is in place?
- 06
Where are units sold, demonstrated, trialled or indirectly exported?
Check the current Australian guidance
Regulatory obligations sit outside your insurance policy. These official sources are the starting point.
External government and industry sources. Tank Insurance is not responsible for their content; confirm current requirements with the relevant body.
Related life sciences guides
Explore cover by business activity
Questions about Medical Devices & Products
Potentially. Insurers assess prototype use, demonstrations, testing, regulatory stage, contracts, future countries and requested limits rather than revenue alone. See our dedicated guide to pre-revenue medical device insurance.
No. It is important regulatory evidence, but insurers also assess intended use, testing, quality, manufacturing, claims, distribution and loss controls.
Not automatically. Recall cover normally has a separate trigger, sublimit, excess and covered-expense definition, and should be requested deliberately.
Sometimes, but North American sales, users, contracts and jurisdiction must be disclosed and specifically accepted. Worldwide territory does not automatically mean worldwide jurisdiction.
General information only. This page does not take account of your objectives, financial situation or needs and is not legal advice. Cover depends on the insurer, policy wording, limits, excesses, exclusions and information disclosed. Read the relevant policy documents and obtain professional advice before deciding.
Put your life sciences risk in front of the right markets
Tell us what you research, build, test, supply or operate, plus any overseas exposure. We will explain the available terms and exclusions before you decide.