Medical Device Registration: What a Chinese Factory Must Hold

Alan Xiao Founder, Sourcing Pioneer

· Updated October 24, 2026 · 12 min read

Medical device registration is three separate things, and buyers usually think it is one. A factory can be registered as an establishment, list the device it makes, and still hold no clearance to sell it in the US. The three are checked in different places, and only one of them is about the product itself. This guide separates them, then shows what to ask a Chinese supplier and how to check the answer.

The Short Answer

Three filings sit behind the words "FDA registered". Anda factory may hold one, two or all three.

The first is establishment registration. It says where the device is made. Andit is renewed each year.

The second is device listing. It says which device that establishment makes. Andit is tied to the registration.

The third is clearance or an exemption. It says the device may be sold in the US at all. This is the one that takes evidence and time.

A factory with the first two and not the third can make your device. It cannot put it on the US market. Andthat duty falls to whoever holds the clearance.

Three Things Behind One Phrase

Factory entry

Where the device is made. The rules set out the entry in 21 CFR part 807. The rules sit in 21 CFR part 807, and the entry carries an identifier a buyer can look up.

Device listing

Which device that establishment makes, under which owner. A listing without a registration is a mismatch worth asking about.

Clearance or exemption

Whether the device may be sold. Most low-risk devices are exempt. Others need a premarket submission, and that is a review, not a form.

The order matters when you read a supplier's claim. A factory that says "we are FDA registered" has answered the first question and left the third open.

The third is the one a buyer actually needs. Becauseit decides whether the device can be sold and under whose name.

Clearance, Exemption and the Class Question

Whether a device needs a premarket review depends on its class. Andthe class depends on risk. This is the part a factory cannot answer for you.

Low-risk devices usually sit in a class that is exempt from premarket review. Moderate-risk devices need a premarket notification, usually called a 510(k). Higher-risk devices need a longer review again.

The class is not chosen by the factory and not chosen by the buyer. It is set by the device type. Andit is settled by reading how the rules treat that type.

Two practical consequences follow. First, a factory that makes a cleared device for one client is not cleared for your device. Second, a device that is exempt for a competitor may not be exempt for your version if the intended use differs.

So the question to ask is narrow and answerable. Which class. Andon what basis. A supplier who answers with a class and a route has done the reading. One who answers with a promise has not.

The Quality System Behind the Registration

A filing is a filing. Behind it sits a quality system. Andthe system is what an inspection looks at.

The rules for that system sit in 21 CFR part 820. They cover design control, purchasing, production, testing and complaints.

For a buyer this matters for one reason. A device can be registered and made in a workshop that keeps no records. Becausethe filing does not check the workshop. The system does.

Three parts of that system show up first in a supplier conversation. Design control decides who owns the drawings. Purchasing control decides whether components are traceable. Complaint handling decides whether a failure reaches anyone.

Ask how complaints are logged and who reads them. Records also decide what an check before the container leaves can actually confirm.

Who Counts as the Maker on Paper

This is where a well-run sourcing project goes wrong. Andthe mistake is quiet.

The maker of record is the party whose name sits on the clearance and the label. For a private label device, that is often the brand, not the factory.

So a brand can own the clearance while a factory in China makes the device. That arrangement works. Andit carries obligations the brand may not expect.

The factory also needs a US agent named. Andthat agent is the address a regulator writes to. A factory without one cannot hold up its end of the arrangement.

Our own experience is that buyers discover this late. They plan a private label launch, choose a factory with a registration. Andonly then learn that the clearance has to be theirs.

What to Ask, and How to Check the Answer

Five items cover the ground. Each one can be checked rather than believed.

The clearance number is the item buyers skip. Andit is the one that decides the launch. Read the intended use on the clearance and compare it with your label.

A cleared number for a similar device does not cover your device. It covers the device described in that review, with its own intended use and its own technology.

One more habit saves a month. Ask the factory to send the lookup result itself, as a screenshot with the address bar visible, then check the same entry yourself.

Five Things Buyers Believe

The first is that a paper saying the device is approved exists and is issued by the regulator. It is not. A filing is a filing by the firm. Andthe regulator publishes the entry rather than blessing the goods.

The second is that ISO 13485 replaces the US route. It does not. A quality system certificate supports a review. Andit is not a clearance to sell.

The third is that a European mark covers the US. It does not. The two systems are separate. Anda device can be legal in one market and unsellable in the other.

The fourth is that a factory with a filing can put your brand on the device and ship. Only if the clearance and the label name the right party.

The fifth is that the class is a detail. It is also the line where device rules meet the labelling rules that sit beside them.

What Goes Wrong After the Order

Most failures here are paper. Andthey surface at the border or at the first complaint.

A shipment arrives under a listing that names a different owner. Andthe entry stalls while someone explains the relationship.

A label carries a brand that is not the maker of record. Andthe mismatch needs a new label rather than a new device.

A component changes supplier. Andthe change never reaches the design file. Whichturns a small substitution into an audit finding.

None of these needs a lawyer to prevent. Some are material questions. Anda component check at the factory catches them earlier than a complaint does.

The specification is also where the label lives. The spec sheet a factory builds from should carry the artwork, the intended use and the maker of record.

Who Has to Hold What

Three parties appear on the paper. Andeach one holds something different. Buyers blur them and then argue about who owns the launch.

Read the table twice. The factory is not the party that carries the launch. Anda buyer who assumes otherwise plans the wrong budget.

The importer is you, or your distributor. The entry at the border is a separate act from the clearance. Andit is checked against the value you declare.

The US Agent, in Practice

A foreign factory needs a US agent. Andthe agent is the address a regulator writes to. That sounds like a formality until something goes wrong.

The agent receives correspondence. Andit does not manage the device. A buyer who assumes the agent handles complaints is assuming the wrong job.

Ask for the agent agreement rather than the agent name. A name on a page proves nothing. Andan agreement shows who took on the role and when it ends.

Two practical checks follow. The agreement should still be in date. Andit should cover the factory you are actually using rather than a sister company.

If the factory changes its agent, the change should reach you. A lapsed agreement means letters go nowhere. Andnobody in the chain notices until a deadline passes.

If the Device Is Already Sold by Someone Else

Many devices reach the US market through a clearance held by a distributor or an original brand. A factory may make it under that clearance and never hold one itself.

That is normal and legal. It also means a new brand cannot simply reuse the number. Becausethe number covers the device as described by the holder, with its own intended use.

Two routes are open. Either the holder adds your label to the arrangement, or the new brand files its own route. The first is faster and needs the holder's agreement. The second is slower and leaves you in control.

Ask which route the factory has seen before. A factory that has done the first route twice can name the holder and the paperwork. One that answers in general terms has not done it.

What to Send the Factory

Four items make the conversation concrete. None of them is expensive and all of them are quick.

The first is the intended use, written in one sentence. The class follows from it. Soa vague sentence produces a vague class.

The second is a description of the technology, in plain words. What it does, what touches the patient. Andwhether it holds software.

The third is the label artwork, including the maker's name. The name on the label is the name that has to match the clearance.

The fourth is the current filing numbers from the factory, sent as a screenshot rather than typed into an email.

Send all four in one message and ask three questions. Which class. Which route. Who holds the clearance today.

What the Border Checks

The border is a different checkpoint from the review. It looks at the shipment, not the device file.

Four things are read at entry. The value. The class. The country of origin. And the name of the party importing.

A mismatch between the label and the entry is the common failure. The label says one maker. The invoice names another. The shipment waits.

Value is the second failure. A low declared value on a device draws attention. Becausedevices are not cheap goods and the numbers rarely fit.

None of this is a trap. It is a list. Read the four items before the box is sealed. Andthe entry runs clean.

Sample Before the Launch

Build one unit and keep it. That unit is the reference for everything that follows.

Photograph the label on the unit. Photograph the same label on the carton. Keep both with the filings.

Send the unit to a lab if the class calls for testing. A test on a hand-built sample is cheaper than a test on a production lot.

Then compare the first production unit against it. A label that moved by two millimetres is a small thing. A label that lost the maker name is not.

Keeping the File

One folder holds the whole story. Five items go in it and none takes long to collect.

The factory filing numbers, as a screenshot. The listing entry. The clearance number with its intended use. The agent agreement. The label artwork with its revision.

Add the sample photos and the test report. Andthe folder answers almost any question asked later.

It also answers the one question buyers ask most often. Can we prove where this came from. A folder does that in a minute. A memory does not.

File it with the specification. Becauseboth describe the same device. The sheet and the filings should never live in different places.

Questions Buyers Ask About Device Registration

The Bottom Line

Registration is three things: where the device is made, what is made there. Andwhether it may be sold. A factory can hold the first two and leave the third to you.

Ask for the identifier, the listing, the clearance number and the agent. Then check all four in public entries rather than in a PDF.

Do that before the tooling is paid. Becausethe class decides the cost of the whole project and it is the cheapest thing to check.