A free sale certificate is one of those documents that gets requested at the last minute, when the container is already booked and the customs broker is on the phone. It is a statement from the competent authority that a product is freely sold in the country of manufacture, and for medical devices it is often the piece that a distributor’s registration file needs before it can even start. The apostille is the layer that makes that document usable in a foreign market.
What a free sale certificate actually certifies
A free sale certificate confirms that a device is lawfully on sale in the country of origin, not that it meets a particular foreign standard. That distinction matters. The certificate is evidence of market presence and regulatory standing, while compliance with the importing market’s own requirements is a separate question answered by a CE marking, a local registration, or a type test. For a supplier in China, the free sale certificate is issued by the responsible authority and is often accompanied by a notarized copy and an apostille so it can be presented abroad.
When a free sale certificate is required
The request usually comes from the buyer’s regulator, from the customs broker, or from a tender file. Some markets ask for a free sale certificate as part of the registration of a new product, and others ask for it afresh at a later registration step. It is worth asking the buyer which authority will receive the document, because that decides whether a simple English issue is enough or whether a local-language and legalized version is required. Suppliers that sell into several country groups keep a standing export documentation pack for this reason.
Apostille: why the standard sheet is not enough
A certificate issued in one country is not automatically accepted in another. The apostille is a single certification added under the Hague Convention that makes a public document legally usable across participating countries, and it replaces the older chain of consular legalisation. Whether a market is a member of the convention decides whether you add an apostille or follow the older route. The HCCH status table for the Apostille Convention is the reference for checking a country’s membership, and the UK government guidance on legalising documents shows how the process plays out in practice.
The documents a medical equipment export usually needs
In practice a medical equipment shipment is often accompanied by more than one document. The free sale certificate sits alongside the declaration of conformity, the quality system certificate, the invoice and packing list, and any test report a market expects. Grouping them so they are issued under one buyer name and one order number saves a lot of time at customs, because the clearing agent is then checking one consistent set instead of a pile of unrelated certificates. Our export team can confirm the document list for a target market before you commit.
One way to keep the process short is to ask the buyer for the exact document list and the exact wording the regulator wants before the order is confirmed. A free sale certificate that names the wrong product model, or that is issued in the buyer’s name when the buyer is a different company from the one on the order, will be rejected and reissued, and re-issuing a notarized document takes time. The same point applies to the apostille, which is added to a specific document and cannot be transferred to a newer version of it. Aligning the buyer name, the order number, and the certificate name at the start avoids a rework that costs far more than ten minutes of questions.
Free sale and apostille video
The video below explains how apostilled documents work, and is a useful reference when a buyer asks for a copy of a certificate that a market will not accept as issued.
Common questions about free sale certificates and apostilles
What is the difference between a free sale certificate and a certificate of origin?
A certificate of origin describes where a product was made, while a free sale certificate confirms that it is lawfully sold in the country of origin. They answer different questions.
Does a free sale certificate need an apostille?
Only if the receiving market is a member of the Hague Apostille Convention. For non-members it follows a different route, so check the destination first.
How long is a free sale certificate valid?
It depends on the issuing authority and the market. Regulators often want a recent issue, so buyers request it at the point of registration, which puts the lead time in the project plan.
Are free sale certificates specific to a product?
Yes. A certificate is issued per product and per manufacturer, so a supplier with a range of devices holds one for each, and a buyer importing several lines should ask to see each.
For a deeper look at the certification side, see our article on ISO 13485 vs ISO 9001: which certificates matter, and for the documents EU importers verify, read about MDR technical documentation for EU importers. If you are handing over a completed project, our guide on post-handover OR documentation covers the same folder discipline at a different stage. The HCCH Apostille Convention status table and the UK government legalisation guide are the two references worth bookmarking for a cross-border document question.
For more detail, see our Labeling and Instructions for Use.
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