Wenzhou, Zhejiang, China
Terry@chinamedsupply.com
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OEM & private label
Your brand on the product, without owning the factory.
Medical devices · mobility aids · home-care consumables
We source the product, check the batch, build the file and ship it under your name. All divisions on one purchase order, and the paperwork travels with the goods.
Replies within one business day, 08:30–18:00 GMT+8. Messages that arrive over our weekend are answered when we open on Monday.
What we actually do
Four things, in this order. Skipping any one of them is how a private-label order turns into a batch of unbranded stock in a warehouse.
We choose the factory
Not the other way round. The factory is picked for the SKU, the certificate it already holds, and how it handles a small first run — not for whoever quotes lowest this month.
We check the batch
Pre-shipment inspection on the line, plus the functional test record or certificate of analysis for products that carry one. You get the record with the shipment.
We build the file
CE marking per product under EU MDR 2017/745, the factory’s ISO 13485:2016 certificate, and FDA establishment registration records. Certificate numbers before you order.
It ships under your name
Your label, your artwork, your carton. A mixed shipment moves on one invoice, one customs entry and one document pack.
OEM or ODM — which one you are buying
The two words get used interchangeably, and the difference decides your tooling cost and your first-order timeline.
OEM — your design
You own the artwork and, where it applies, the tooling.
- You supply the artwork files; we print labels, IFUs and cartons to them.
- If the shape differs from a standard model, tooling is quoted separately and confirmed in writing before any deposit.
- MOQ applies per SKU, not per order.
- Slower to start, but nothing about the product is shared with your competitors.
ODM — our design, your brand
Pick from what we already make; change the colour, logo and packaging.
- No tooling cost on standard models — the mould already exists.
- Faster first order: the mould exists and the certified model is already in production.
- Best fit for a first container or a market test.
- Cosmetic changes only — the housing stays as certified.
One thing to settle before you brand it
Under EU MDR 2017/745, putting your own name on a device makes you the legal manufacturer: the Declaration of Conformity is signed by you, the UDI is assigned to the device under your name, and — if you are outside the EU — you appoint the EC REP and register in EUDAMED. We build the technical file, the test reports and the factory certificates behind it, and we will show you exactly what is yours and what is ours before you order.
What it costs to start
No design budget on your first order if your existing artwork fits. The three numbers that decide everything else are below.
| Division | Typical minimum first order | Why that number |
|---|---|---|
| Medical devices | 500 pcs | Batch records and calibration have to be traceable per run. |
| Mobility & daily living aids | 100 pcs | Freight is the constraint, not the tooling; a container plan is quoted with the price. |
| Home healthcare supplies | 1,000 pcs | Consumables run on print and film, so the minimum is the print run. |
Samples before you commit
Stock samples of standard models ship in 3–5 working days; you cover the courier. Where the artwork matters, a printed label proof comes with them.
3–5 working daysHow a first order runs
You send a rough spec
Product, quantity, market and what your brand needs on the box. A photo of a competitor’s pack is a valid spec.
Reply within 1 business dayYou hold a sample
The model, the label and the carton. Nothing goes to production before you have held what you are buying.
Documents start before production
The file is assembled while the goods are being made, not after. That is why the pack ships with the order.
You watch the batch
Inspection on the line, with the test record. If it fails, it does not leave the factory.
It lands — and we are still here
Spare parts and refills stay as separate line items, so after-sales does not depend on a new container.
What to send us
- The spec, rough is fine. Product, function, size, and the standard it has to meet.
- Artwork files. AI or PDF, with bleed and colour references. A dieline if your carton already exists — if it does not, we can work from the label only.
- The destination market. It decides the document set, not the SKU.
- Quantity per SKU, and whether one container mixes divisions.
- What happens after arrival. Shelf-ready pack, pharmacy peg, or plain carton for your own warehouse.
If we cannot make it, we will say so in the first reply — and usually point you to someone who can.
If we can, you get a price and a sample plan within two business days.
Terry — you won’t be handed to a different person at each step.
The four claims we will not bend
The same four lines that appear on the homepage. They are worded this way because a buyer, or an auditor, will check them.
| CE marking | Per product, under EU MDR 2017/745. A notified body and its certificate number where one is involved; for self-declared Class I, the factory’s DoC and the technical file — and where the label carries your name, that DoC is yours to sign. |
|---|---|
| ISO 13485:2016 | Held by our partner factories, not by the export office. We will name the site and the certificate. |
| FDA | Facility registration, not product clearance. We do not hold product-specific FDA clearances or approvals (510(k) or PMA) and will not imply them. |
| Traceability | Lot number on the label, the test record for that batch, and the shipping documents that match them. |
Do you own the factories?
No. We are the layer between you and the manufacturers: we decide which factory gets your order, check what comes off the line, build the file and hold the delivery date. The ISO certificates belong to the sites, not to us.
Who owns the artwork and the tooling?
Your artwork stays yours. Tooling is quoted per project, and its ownership — including whether the mould can be moved to another supplier — is written into the quotation before any deposit.
Can I start with one SKU?
Yes. MOQ applies per SKU, not per order, and a container can mix divisions. That is how most first orders start.
How long does a first production order take?
Production lead time is quoted per SKU once the sample is approved — it depends on the factory’s line and the size of the print run. The parts that do not move: samples in 3–5 working days, and documents that start before production.
Send the spec. If we can make it, you will have a price and a sample plan.
If we cannot, you will hear that in the same reply — and usually who can.