Medical device import clearance
Device entries depend on regulatory status established long before the shipment — registration, listing, and where required, marketing authorisation.
Licensed U.S. customs brokerage. Customs broker of record; movement coordinated through vetted partners.
Medical device import clearance covers customs entries for devices ranging from simple instruments to complex equipment. The entry depends on regulatory groundwork completed beforehand: establishment registration, device listing, and for many devices a marketing authorisation. The device class determines how much of this applies.
Key takeaways
- Device class determines the regulatory pathway and what must be in place.
- Establishment registration and device listing are separate obligations.
- Many devices require marketing authorisation before importation for commercial distribution.
- The product code must match the specific device, not the general category.
- Initial importers carry their own registration obligations.
Class decides the pathway
Devices are grouped by risk. Lower-risk devices may be subject mainly to general controls; higher-risk devices require premarket authorisation before commercial distribution. The entry itself does not establish any of this — it reflects work already done.
Importing a device that lacks the required authorisation is not a paperwork problem that can be solved at the port.
Registration is not one thing
The foreign manufacturer registers its establishment. The device is separately listed. The U.S. initial importer has its own registration obligation. These are distinct, and having one does not satisfy another — a common and costly assumption.
How it works
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01
Device identified
What it is, its intended use, and the class that follows.
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02
Registration verified
Manufacturer establishment registration, and initial importer registration.
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03
Listing confirmed
The specific device listed with FDA.
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04
Authorisation confirmed
Where required for the class and intended use.
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05
Entry filed
With product code and affirmations matched to the specific device.
Common mistakes
- Assuming registration covers listing. They are separate obligations.
- Overlooking the initial importer's own registration. It applies to you, not only the maker.
- A product code for the general category. It must match the specific device.
- Importing without required authorisation. Not resolvable at the border.
- Ignoring intended use. It can change the class and the whole pathway.
Questions
What determines a device's class?
Its risk profile and intended use. Lower-risk devices face general controls; higher-risk devices require premarket authorisation. Intended use matters as much as the physical article, and can move the same product between classes.
Do I need to register as an importer?
U.S. initial importers of medical devices generally have their own establishment registration obligation, separate from the foreign manufacturer's. It is a common gap for importers new to the category.
Can I import a device for evaluation?
There are limited pathways for samples, research and investigational use, each with its own conditions. They are narrower than people expect, so confirm the position before shipping rather than after.
What is the most common device import problem?
Registration and listing gaps — usually the manufacturer registered but the specific device not listed, or the importer unaware of its own registration obligation. Both are verifiable before shipping.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.