Build your brand on a factory that already ships: OEM, ODM and private label

What to ask for before you release a deposit

• A named program tier. If a supplier cannot say whether a quote assumes an existing mold or new tooling, it has one MOQ for everyone — which usually means it is built for volume buyers, not first orders.
• Per-SKU material documentation. A food-grade silicone migration test report from a named accredited laboratory for the product you are buying, against FDA 21 CFR 177.2600. A template PDF is not an answer.
• Samples before commitment. A factory that will not sample until you commit to production is protecting its schedule, not building a relationship.
• Market marks named explicitly. UKCA for Great Britain, FCC for the United States, PSE for Japan, RCM for Australia and New Zealand, plus REACH and California Prop 65 where your retailer asks. UN38.3 and an MSDS for anything rechargeable.
• Quality-system and audit evidence. ISO 9001 as baseline, ISO 13485 where your own quality function requires it, and a recent third-party factory audit you can read rather than a certificate you cannot.
• A written AQL. Sampling level, defect tolerance, golden sample, and pre-shipment inspection tied to the balance payment. “Every unit is checked” is not a plan.
• Landed cost, quoted separately. Product cost, packaging development, tooling, testing and freight as separate lines. A single blended unit price hides where the MOQ is really coming from, and it is the number that decides your margin once duty and import VAT are added.

How buyers vet a wellness device factory in Dongguan

Sourcing threads and procurement job descriptions keep asking the same questions, and none of them are answered on a price list. These are the eight we get asked most, and what we answer for each.

• Factory or trading company. Ask for the model numbers behind the catalog. We publish ours — every product page carries the factory model number, and we can name the base SKU a variant is built from. Ask what happens when a mold needs repair: a factory answers on the call, a trading company has to relay the question.
• On-site process audits. Send your own inspector or a third party at any point before shipment, and walk the floor on a live video call rather than watching a clip. A supplier who will only show you a showroom is describing a trading operation, whatever the business license says.
• Certificate scope and validity — verify it yourself. Read a certificate as product-specific evidence: does it name your model, does it name the standard your market actually requires, and is it still in date. Social compliance schemes run on finite validity, so a lapsed report means the factory is not certified today. We hand over the test reports and let you check the scope rather than asking you to trust a badge.
• Test documentation by SKU. Material and test documentation is issued per model number, not per catalog. A report covering a similar device does not cover yours — housing, motor and charging circuit differ between variants of the same line, and that is exactly where a claim quietly stops being true.
• Pre-production sample from bulk material. The sample you approve should be built from the material that will run in production, not from whatever is on the bench that week. That sample becomes the golden sample the bulk order is measured against, and it is the cheapest way to end a “sample quality versus bulk quality” argument before it starts.
• Non-conformance, written down. Ask what happens when a batch fails: who raises it, how it is documented, what corrective action looks like, and whether the balance payment is tied to the outcome. “We will fix it” is not a process, and a supplier without one will renegotiate the meaning of “defective” after shipment.
• Total cost of ownership, not unit price. A unit price is one line. Total cost of ownership adds tooling amortization, testing, freight, duty and the cost of a failed batch — including the reorder you cannot make because a launch window closed. Model that number before you commit to a margin, not after.
• Resale documentation. We issue a commercial invoice, a packing list and the test reports behind the shipment so your broker can file against them. A resale certificate is different: it is issued to you by your own tax authority, and no supplier can issue one on your behalf — anyone offering to “handle it” is worth questioning.

Two of these are worth stating plainly because they are the ones buyers expect us to dodge. We are a single wellness device factory in Dongguan, running since 2014, and we will say so in writing. And if a question above has an answer that does not suit us, we would rather give you the real one than the convenient one — a first order survives an honest answer; it does not survive a surprise in week six. The rest of the commercial terms are on the wholesale page, and the questions buyers ask before release are answered in the FAQ.

Who owns the mold, and why it decides your exit

Tooling is the clause buyers read last and regret first. A mold costs somewhere between a few thousand and low tens of thousands of dollars depending on cavity count and finish, and whoever pays for it usually owns it — but “usually” is doing a lot of work in that sentence. The ownership question is not abstract: it decides whether you can move production to a second factory in year three, and whether a supplier can hold your product hostage by holding the tool.

Four things belong in writing before the first tooling invoice, and none of them are unusual requests. A factory that resists them is telling you something about year three.

One distinction that saves arguments: the mold is a tool, and the design is a separate right. Owning the steel does not automatically give you the industrial design or the packaging artwork, and owning the design does not give you the tool. Both need naming, and the design side is governed by the terms on our copyright and design ownership page. Where your brief includes drawings, CAD files or unreleased product plans, the confidentiality terms are on our privacy page — a mutual NDA is signed before any of that changes hands, and it covers tooling drawings the same way it covers the product itself.

Tooling cost ranges are indicative of small-cavity injection tooling for devices in this size class and vary with cavity count, steel grade and surface finish. Clause wording above reflects common practice in contract manufacturing; it is not legal advice, and a contract lawyer in your jurisdiction should review the final text.

Cross-border reality

Twenty-seven countries are not one market. Labelling rules, responsible-person requirements, restricted-market lists and import documentation all differ by destination, and a document pack that clears one border can stall at the next. We quote lead times and documentation per destination for that reason, and we will tell you plainly where we cannot ship rather than let a parcel be seized. The full destination and certification list is on our compliance page.

Program tiers, MOQ ranges and lead times above are our published terms. Buyer-side questions are drawn from public sourcing-group discussion; no survey data is claimed.

• Compliance pack — CE Declaration of Conformity, RoHS statement, MSDS, IPX5 test report and UN 38.3 on every order, with issuing-body reference numbers so your compliance team can verify each one independently.
• Materials — body-safe food-grade silicone, phthalate-free, non-porous; meeting CE, RoHS, FCC and FDA material standards.
• Four-stage QC — IQC, IPQC, FQC and OQC, with 100% final inspection before shipment and a first article inspection report on the first unit off the line.
• Third-party welcome — SGS, Bureau Veritas or QIMA inspection can be arranged before the container loads.
• Packaging — Pantone matching, dieline and 3D mockups from the first sample round; NDA-protected designs. Outer cartons ship plain, with a neutral SKU code and no product photography.

The order to run those checks in, before any deposit moves

A checklist is only useful in sequence. The one that holds up in practice is staged verification: start with the cheapest checks and let a failed one stop the process before a bulk order is placed or any money is involved.

1. The legal entity, not the sales contact — the registered company name, its registration number and registered address, checked against the public registry. A polished site, a quick video call and a low price are all easy to copy; a registration record is not.
2. What the business is licensed to do — whether the registered scope of business covers manufacturing rather than only trading and sales. This is the difference between a factory and an intermediary, and it decides both your price and your control over quality.
3. Written specification and a sealed reference sample — material, dimensions, tolerances and marking agreed in writing, and an approved sample sealed and held by both parties. Everything downstream is measured against that unit.
4. The right to inspect, in the contract — a named AQL standard, a pre-shipment inspection right, the Incoterm and named place, and a penalty clause for defects or delays. Terms agreed in conversation do not exist.
5. Physical verification — an on-site or third-party audit before the balance is released, confirming the address matches the license, the equipment belongs to the company and the line is actually running.
6. The payment name — the beneficiary account must carry the same legal name as the business license, the proforma invoice and the contract. Most losses in this industry are not defects; they are payments that went to the wrong entity. A request to pay a personal account, or a different company’s account, ends the conversation.

Two of those steps cost nothing and catch most of what goes wrong. Ask for a live video factory audit — a call showing the floor that morning, not an edited clip — and run a reverse image search on any product photography a supplier sends you, because stolen imagery is still the most common tell. If a supplier pressures you to skip a step, that pressure is the finding.

NCR/CAPA and quarterly-business-review practices above reflect common contract-manufacturing procedure; they are not legal advice, and your procurement team should set the exact thresholds and response windows.