Is it illegal to resell medical equipment?

Medical equipment can generally be resold when it was acquired lawfully, remains safe and functional, and is authorized for distribution in the relevant market. However, legality depends on the product type, seller’s activities, buyer, device condition, and jurisdiction.

In the United States, a domestic distributor that only resells devices already in commercial distribution generally does not have to register or list with FDA. FDA similarly identifies remarketers or refurbishers of used devices as generally outside federal registration and listing requirements when their activities do not constitute remanufacturing. Initial importers, relabelers, repackagers, single-use-device reprocessors, and remanufacturers have additional obligations.

Resale may become unlawful or restricted when:
• The product is counterfeit, stolen, recalled, expired, or adulterated
• A prescription device is sold outside permitted professional channels
• Required state, national, or DME supplier licenses are absent
• Sterile packaging or safety features have been compromised
• A single-use device has been informally cleaned and offered for reuse
• Labels, intended use, or traceability information are altered improperly
• Repairs significantly change safety, performance, or intended use

FDA treats significant changes to a finished device as potential remanufacturing, which can trigger registration, listing, quality-system, reporting, and marketing-submission requirements. Prescription devices may also be sold only to or on the order of an appropriately licensed practitioner.

Resellers should obtain jurisdiction-specific legal or regulatory advice before handling restricted or used equipment.