A risk-and-controls explainer for procurement and supply-chain teams, current as of September 2026. It is not legal advice, it makes no allegation about any supplier, and it contains no scare statistics.
Grey market, parallel import and counterfeit are three different things that get used as synonyms, and the difference matters because the controls are different. A device that has moved through distribution channels the manufacturer did not authorise may be entirely genuine; a counterfeit device may have entered through an authorised channel. Treating all three as one risk produces controls that miss the actual problem in each case.
Grey market, parallel import and counterfeit
A parallel import is a genuine product sold outside the manufacturer’s intended distribution arrangements ¡ª bought in one market and resold in another, often at a different price. A grey-market device is the broader category: legitimate product moved through channels the manufacturer did not intend or approve. A counterfeit is a different thing entirely: a product that is not what its labeling says it is.
The distinctions decide the control. For parallel imports, the questions are about market authorisation, labeling in the destination language, warranty validity and support entitlement. For counterfeits, the questions are about provenance, identity verification and acceptance testing. For grey-market goods generally, the practical issue is usually traceability: nobody in the chain can fully document where the device has been.
Risk map
| Risk | What it looks like in practice | Primary control |
|---|---|---|
| Regulatory | A device supplied in a market where it is not authorised, or without the required local labeling | Confirm the authorisation status for the destination before purchase |
| Traceability | Incomplete history, unknown storage, no service records | Require serial-level records and document what is missing |
| Handling | Storage and transport outside the conditions the labeling specifies | Storage evidence and receiving inspection |
| Warranty and support | Manufacturer support unavailable because the device was not supplied through the authorised channel | Establish the support position in writing before purchase |
| Identity | A device that is not what its labeling states | Identity verification and receiving inspection, plus manufacturer escalation where authenticity is in question |
Procurement controls
Controls work best as a sequence rather than as a single check. At the supplier stage, establish identity, references and the ability to show the goods. At the item stage, verify the model, part number and serial against the documentation, and photograph what arrives. At the acceptance stage, confirm that the unit performs as described and that the records describe this unit. And at the escalation stage, have a defined path for anything that does not reconcile.
- Supplier vetting that produces documents rather than assurances.
- Serial-level identification recorded before payment where the value justifies it.
- Documentation review that establishes the market the device was supplied for.
- Receiving inspection with photographs and a written acceptance decision.
- An escalation path that does not depend on an individual deciding to raise a concern.
Due-diligence steps
Four questions cover most of the ground. Which market was this device intended for, and is it authorised here? What is the documented history, and what is missing? Is the support position ¡ª service, parts, software ¡ª available to a buyer in this market? And what does the labeling actually say, including its language and its stated manufacturer?
Those questions are answerable before payment in most transactions, which is what makes them useful. Where a seller cannot answer them, the correct reading is not that the device is illegitimate; it is that the buyer has no basis for concluding anything about it.
Escalation and documentation
When something does not reconcile, document facts rather than conclusions. Record what was expected, what was found, and the evidence for both, without characterising the seller’s intent. Quarantine the item, preserve the packaging and paperwork as received, raise the issue through the contract’s inspection and remedy terms, and notify the manufacturer where the authenticity of the product is in question. Where a public alert is relevant, check the regulator’s own publication rather than a summary of it.
The same records that support an escalation also support a future audit. A file that shows what was checked, what was found and what was done about it is the practical difference between a controlled process and one that relies on recollection.
Why this category attracts scrutiny
Nothing about the controls above is specific to medical equipment, but the consequences of applying them late are. A device that enters a hospital through a channel its manufacturer did not intend may still be genuine, and the practical problem is not its origin but the information gap around it: the buyer cannot establish what the device is, where it has been, or whether support obligations transfer to them. In a clinical setting, that gap is what a procurement process is supposed to close before the equipment is used, because unlike a consumer purchase, the equipment will be operated on patients by staff who assume someone checked.
That assumption is the reason this page exists. The controls described here are ordinary purchasing discipline applied to a category where the stakes make them worth following deliberately.
Questions buyers ask
Is buying a parallel import allowed?
That depends on the market, the device and the arrangements in place, and it is a question for your own advisers. What this page covers is the control set that makes such a purchase auditable.
Does buying from an authorised dealer eliminate the risk?
It reduces the supply-chain risk substantially, because the provenance is clearer. It does not replace item-level verification for used equipment, where condition and configuration still have to be established. Even an authorised channel can contain units with incomplete records ¡ª that is exactly why item-level verification matters regardless of who the seller is.
What is the single most useful control?
The serial-level record. It is what distinguishes a device with a history from a device with a description, and it is what makes every other document in the pack checkable.
Name the risk precisely, apply the control that matches it, and document what you found. If you are sourcing equipment and want the records that should travel with a unit, ask HHG for the documentation on a specific item, or browse the current listings. Related reading: compliance considerations in cross-border resale and how customs cooperation targets counterfeit devices.