How to import class II medical devices from China
This page covers the Chinese export side only: finding the factory, agreeing the terms, and getting the goods out of the country. Registering the device in your own market is a separate exercise, and it is not described here.
What this page covers, and what it does not
An import has two halves, and they are usually described as if they were one. The first half happens in China: choosing a supplier, verifying what it holds, agreeing terms, producing the goods and clearing them for export.
The second half happens where you are. Registering the device, meeting your own labelling rules and clearing the goods on arrival are set by your regulator, not by the factory.
Market Access — The registration step in your own market is a separate exercise, and we describe what we can and cannot do for it there.
Step 1 — Confirm the device and its registration number
- Establish which product you are buying, at which specification, and under which registration number.
- Look that number up on the national authority enquiry system before you sign anything.
- Confirm whether the number is held by the manufacturer you are negotiating with or by another entity.
- Match the product name on the certificate against the name you intend to put on your own label.
The registration number is the anchor for everything that follows: the label, the invoice, the export documents and your own market submission. Settle it first and the rest is clerical.
Step 2 — Agree the commercial terms in writing
- Minimum order quantity, unit price and payment terms, before sampling begins.
- Sample route and sample cost, and whether a pilot batch is available as a separate step.
- Lead time for a first order and for a repeat order, quoted as two different figures.
- Who owns the artwork, and who pays when the packaging changes.
Our minimum order quantity is 10,000 boxes per product. Our other standard commercial terms are set out on the FAQ page.
Step 3 — Assemble the export documents
Packing list and commercial invoice
The commercial description of the shipment. The product name here should match the registration certificate wording, not a marketing name.
Customs export declaration
The declaration made to Chinese customs when the goods leave the country. Made by the exporter or its agent.
Certificate of origin
Where the goods were made, evidenced in the form your market accepts.
Transport classification
Whether the material is classified as dangerous goods for transport, and therefore which carriers and routes can accept it.
What else is required depends on the product and on your market. We list what we issue as a matter of course, and what we can obtain on request, when a quote turns into an order.
Step 4 — Agree the packing and the labels
Export packing is a specification, not a default. Agree the carton, the inner protection and the pallet configuration before production starts, because changing them afterwards costs a production slot.
Two labels travel with the goods, and they are different documents. The retail label is your artwork and your legal responsibility in your own market. The carton label is a logistics document. Keep them separate in the brief, or the factory will optimise the one it can see.
Step 5 — Choose the terms of sale
- EXW places the goods at the factory and leaves almost everything after that to the buyer.
- FOB places them on board at the named port, and the risk passes as they are loaded.
- CIF carries the goods to your port at the seller's cost, but the risk still passes when they are loaded.
- DDP puts the seller in charge all the way to the destination, including import clearance.
Incoterms are standard definitions published by the International Chamber of Commerce, not a negotiation in themselves. Whichever term you choose, name the place, and confirm in writing who is responsible for the export declaration.
Under most terms that declaration is the seller side of the transaction and the import declaration is yours. It is worth confirming anyway: assumptions at that boundary are where disputes start.
Where our part ends
As a manufacturer we handle the goods, the export documents and the export declaration. What we cannot do is make a device compliant in a market where we hold no licence.
That is not an apology. It is where the line sits for every manufacturer, and a supplier who offers to cross it should be asked under which licence they claim to do so.
Where to go next
- Market Access — Start on the destination half, where registration and labelling rules sit.
- Certifications — Check the registrations this site holds before you request anything.
- What documents your Chinese supplier must provide — Assemble the full document set, not just the export paperwork.
- FAQ — Read our minimum order quantity, lead times and sample terms.
