FAQ · Compliance, testing and documents
Compliance, testing and documents: 32 answers
Certificates, test standards, sampling plans, HS codes and the paperwork at the border. The questions that decide whether the shipment clears. Part of the wholesale FAQ — the 4 groups here are the questions buyers ask in this order, and the answer to each is the one we would put in a quotation rather than the one that sounds best.
Quality & compliance
How is the product tested before shipment?
Five stages: incoming motor screening for balance and current draw, a full discharge soak on every assembled unit, a motor noise check against the ≤60 dB at 30 cm specification, runtime sampling on the same rig, and an outgoing audit of charge, mode count, button response and finish. This holds the outgoing defect rate below 0.1% with 100% final inspection, not sampling.
How do you describe the product in compliance terms?
Slow Duo is positioned as a wellness device for relaxation and comfort. We do not claim it treats, cures or heals any condition, and our copy avoids medical claims so that partners can brief their own compliance teams on defensible language.
Why do you never publish retail prices or sell direct?
We are a B2B-only brand. We do not sell to end consumers and we do not compete with our clients' channels, so there is no retail price to publish. Commercial terms are set per market and per volume, and quoted directly to you.
What is the difference between CE, RoHS and REACH?
They regulate three different things, and none of them substitutes for another. CE is the manufacturer’s declaration that a product meets the EU directives that apply to it — for these devices, EMC, Low Voltage and RoHS. RoHS restricts ten specific substances in the electrical and electronic parts. REACH governs chemical substances in the article as sold in the EU, including the silicones, colorants and coatings. A product can satisfy all three and still be refused over a labelling point. The three regimes compared →
Do I get a per-batch test report, or only a brand-level certificate?
Both exist, and they are not the same document. A brand-level certificate says a product family was tested at some point; a per-batch report is tied to the units actually in your shipment. Ask for the second one before you book freight — it is the document most often missing when goods are held, because it exists and is only released when somebody asks for it. What ships with an order →
What is UN38.3, and does my shipment need it?
UN38.3 is the transport test for lithium cells and batteries: altitude, thermal, vibration, shock, external short circuit and overcharge. Any air or sea movement of a lithium cell needs it, so a rechargeable device cannot be booked without one. It is a transport test, not a product safety certificate, and it sits in the battery layer of the compliance stack rather than replacing anything in the chemical or labelling layers. Where each document sits →
Is the silicone phthalate-free?
Yes, and it is screened rather than asserted. Phthalates are screened to REACH Annex XVII across six groups with a not-detected result, and restricted substances are measured to IEC 62321 across ten substances, all below the EU threshold. "Body-safe" printed on a box is a marketing word; the screen behind it is the part worth asking to see. What body-safe actually covers →
Shipping, documentation & verification
What shipping terms and modes do you use?
Ex-works, FOB Shenzhen or Guangzhou, or CIF. Samples move by DHL or FedEx; bulk orders by air or sea. We prepare carton marks, barcodes and the export documents to your importer's specification, and can coordinate directly with your freight forwarder.
Can one order mix models, colours and packaging formats?
Yes. Combine the three dual-motor and two single-motor models freely to reach the minimum, and mix packaging configurations within the same shipment as long as each meets its own minimum. Cartons are marked per SKU in 6 / 12 / 24-unit inner packs so your warehouse can receipt without repacking.
What documents ship with an order?
CE Declaration of Conformity, RoHS certificate and 10-substance report, FDA material compliance statement, MSDS for all skin-contact components, the per-model water-resistance batch test report (your model's own rating), product spec sheet, commercial invoice, packing list and certificate of origin. Battery and freight documents — UN38.3, IEC 62133-2, the DGM air declaration and the sea-freight identification certificate — are available on request.
Which markets do you ship to, and what does each require?
We have served 30+ export markets since 2014. For the US we prepare FDA material compliance and MSDS — FCC is not required for this app-free range. For the EU, CE covering LVD 2014/35/EU, EMC 2014/30/EU and RoHS 2011/65/EU, plus WEEE guidance. The UK takes UKCA on request, Australia RCM, Brazil MSDS for customs, Japan PSE, and South-East Asia a CE plus MSDS baseline.
Can I audit the factory or book a third-party inspection?
Yes, and we welcome it. SGS handles material and substance testing, Bureau Veritas reviews the CE technical file and electrical safety to IEC 62368-1, and QIMA runs pre-shipment AQL 2.5 / 4.0 sampling at the factory with reports returned within 24 hours. You can book QIMA directly using the factory address — we charge no coordination fee.
Does the platform support app control if my market needs it?
The Slow Duo range is app-free by design — no app, no account, no pairing, which is a selling point at retail. If your market requires app control, the same factory builds BLE 5.0 devices with white-label app capability: your app name, icon, colour theme, custom vibration patterns and OTA firmware updates. Raise it in the brief and we scope it as a separate programme.
Do I need UKCA as well as CE for the United Kingdom?
For the UK market, UKCA is the marking that applies, and it applies on its own rather than alongside CE. UK REACH covers chemicals separately, and the labelling rules require an English warning label plus a named UK importer. If one consignment goes into both the EU and the UK, it carries both document stacks. Destination by destination →
Who has to be named as importer of record?
You do, or the importer you appoint does. Both the EU and the UK require a named economic operator with an address on the packaging and in the technical file, and the factory cannot be that entity for goods sold under your brand. It is also decided late — after the product is finished — which is exactly why it is the row most often missing when a shipment is inspected. Five destinations compared →
Tariffs, HS codes & landed cost
How do I find the right HS code for a massager or vibrator?
Start from what the device does and what it is made of, because no schedule has a heading written for the product itself. In practice three arguments get used: an electrical-apparatus heading where the powered function is the point, a toys heading where the argument rests on purpose, and a massage-apparatus heading where the product is genuinely sold as one. The first six digits are the international Harmonized System; everything after them is national, and the rate lives in the national part — so the honest answer is that the code is a decision made by your broker against a specific schedule on a specific date, not a fact the factory can hand you. What we supply is the input to that decision: material by component, motor and cell specification, and whether the device carries a radio. How classification and clearance work →
Why does the same product get a different HS code in the US and the EU?
Because only the first six digits are international. The Harmonized System is maintained by the World Customs Organization and every member schedule is built on it, but each administration then splits those six digits its own way — ten digits in the US HTS, a different structure in the EU TARIC and in the UK tariff — and the duty rate attaches to the national split, not the international stem. That is why a supplier quoting "the HS code" without naming the schedule has quoted half a code, and why a classification that holds in one market does not travel to the next. Tariff engineering that assumes it does is how a landed-cost model ends up wrong by a margin nobody planned for.
Is the US de minimis exemption still available for small shipments?
No — treat it as gone and model from there. The low-value duty-free limit known as de minimis was suspended in 2025, first for goods of China and Hong Kong origin and then for all origins, so a parcel that used to clear with minimal paperwork now needs a classification and a duty payment like any other import. The practical effect on this category is that the small test shipment stopped being a cheap way to validate a product: a first order of a few cartons now carries the same entry overhead, proportionally, as a pallet. That is an argument for putting the sample spend into samples and the first production run into one shipment rather than splitting it. What the first order looks like →
What belongs in a landed cost that buyers usually leave out?
The fixed tail. Brokerage, bond minimums, entry filing and inland delivery are charged per shipment or per entry, not per unit, so they do not shrink when the order does — which is the arithmetic reason 200 units cost more per unit than 800 with no volume discount involved, and why splitting a first order into two shipments usually costs more than one shipment of the same total. On the value side, the base every percentage is applied to is the customs value rather than the invoice total, and it is adjusted for items the schedule says belong in it. Build the model with your broker before you set a retail price, not after the first entry. The seven layers, one by one →
Certification, samples & verification
How do I verify a CE, RoHS or FDA material statement is genuine?
Ask for the issuing body and the report number, then check them against the named laboratory (SGS, Bureau Veritas, TÜV) rather than trusting a PDF. A real document names the exact standard and the tested sample; a generic "CE certified" stamp on a product photo is not a certificate. Per-model material declarations and the lab reports behind them are listed in the document pack for every shipment, and the three regimes are compared in the FDA vs REACH vs RoHS guide.
What does a sample include, and how fast does it ship?
Stock samples dispatch in 3–5 business days as a finished, retail-ready unit so you can check the feel, noise and the water-resistance rating applicable to that model. A custom sample follows the OEM lead time (15–25 days on existing tooling) because it carries your colour and artwork. The sample is the moment to run the field checks from the body-safe silicone guide before you commit to a mould.
What is first article inspection, and when is it required?
Before a new or modified tool runs a full order, the supplier builds a small number of units and proves them against the drawing, material spec and control plan; PPAP packages that evidence for the buyer to sign off. It is the gate in front of mass production, separate from AQL lot sampling at the end. The AQL 2.5 guide places it in the sequence and the four-stage QC page shows where the first article sits relative to final inspection.
Will the documents clear customs in the EU, UK and US?
The pack is prepared per destination: CE (+UKCA for the UK) for Europe, RoHS substance analysis by SGS or Bureau Veritas, FDA material statements for the US, and market-specific marks on request. What matters at the border is the right document for the right market, not a single certificate that covers everything — the destination split is laid out in the market compliance matrix.
How do I check a certificate number against the issuing body?
Go to the certification body or test laboratory website yourself and enter the report number; do not scan a QR code printed on a PDF supplied by the seller. Check that the company name matches the business licence and the invoice, that the scope names the site, process and product category, and that the report has not expired. Refusal to supply the original file is the answer. The pack with each issuer named
Does a brand-level certificate cover the batch I am buying?
No. A type certificate says a design and material combination was tested at some point; a per-batch report is tied to the units in your shipment. Ask for the second one before you book freight, because it is the document most often missing when goods are held. Read the scope rather than the cover page, and check the date. Where the batch record is produced
Which documents must arrive before artwork approval?
The material declaration, the compliance scope for your destination market and the label or packaging substantiation. A recycled-content or origin claim on the carton is a claim about the product, so the evidence has to exist before the artwork is locked, not after a print run. Asking in this order also catches a certificate whose scope does not cover the printed version. Which file each market needs
What is a technical file, and who has to be able to produce it?
The technical file is the evidence bundle standing behind a conformity mark: drawings, bill of materials, material declarations, test reports, the risk assessment and the signed declaration itself. The manufacturer assembles it; the importer is the party who has to produce it on request, which is why a file you cannot read is worth about as much as no file. We hand over the technical file for the model with every shipment, and the document pack lists exactly what it contains so the list can be checked against what arrived.
Is a laboratory report the same thing as a certificate?
No, and using them as if interchangeable is how a clearance file ends up holding three documents that prove nothing together. A test report records what one laboratory measured, on one sample set, against one method, on one date. A certificate is issued by a certification body against a published scheme, and it covers a scope rather than a batch. A declaration of conformity is the manufacturer's own signed statement that the product meets the directive, supported by the first two. A border officer asks for the declaration first and the reports behind it second — so the file should be assembled in that order. What each market requires at the border
Can you send me the text of ISO 3533 so I can check the clauses?
No, and nobody who has not bought it can. ISO 3533:2021 runs to 16 pages, sits under ICS 97.170 and is sold by ISO, so its clause numbering and annexes are behind that purchase. What we can give you is what the free record states — the scope, in ISO's own words, covering materials, design and user information for products in direct contact with genitalia and/or the anus, and excluding medical devices, cosmetics, lubricants and massage oil. What we will not do is recite clause numbers from memory or from another blog post, which is what most pages in this category do. Ask a supplier who quotes "clause 5.2" to show you the page. What the standard covers, and what it does not
Does an IPX7 rating mean I can rinse the product under the tap?
Not by itself. IPX7 is an immersion test — a stated depth for a stated time — and rinsing is a jet, which is IPX5 or IPX6 measured through a nozzle at a stated flow rate. The levels are separate tests rather than steps on one ladder, so a unit can pass one and fail the other, and a housing optimised for a long low-pressure soak is not thereby optimised for a jet aimed at a seam. Specify both where both matter, and name the condition next to the level: "IPX7, 1 m, 30 minutes" is a specification, "IPX7" alone is a label. Which cleaning practice each rating covers
My brand is on the label. Who signs the EU declaration of conformity?
You do — or the importer named on the pack, if that is a different company inside the EU. The declaration is issued by whoever places the product on the market under their own name, so a factory declaration cannot stand in for yours once your logo is on the box. What the factory owes you is the evidence the declaration rests on: the technical file, the EMC and LVD reports for the mains adaptor, the RoHS report, the material reports, the risk assessment and a template declaration to fill in. A supplier who offers to "provide the CE certificate" is describing a document that does not exist for this category, and that is worth noticing before the first shipment rather than after customs does. What the file has to contain, market by market
Is IPX5 the same as IP55?
No, and the difference sits in the first digit, not the water. IPX5 means dust protection was not rated — the X is the absence of a claim, not a low score — and the water test is a 6.3 mm nozzle at 12.5 litres a minute for at least three minutes. IP55 means dust-protected in the first digit and exactly the same water jet in the second. So IP55 is IPX5 plus a dust claim; it is never a higher water level. The expensive mistake runs the other way: a listing that says IP55 has said nothing about immersion, and an IP55 unit pushed into a basin is outside the test it passed. Write both digits when both were tested, X when the dust test was not run, and ask which laboratory ran the first-digit test on which sample. IPX ratings, digit by digit and the report that proves a rating.
Where the answer is a document rather than a sentence
- Which market asks for which document, side by side?
Five destinations compared in one table — EU, UK, US, Canada and Australia — with the marking and chemical requirement for each. The differences between them, rather than the requirements themselves, are where shipments get held.
Market compliance matrix- Who tested it, and what does the report actually say?
The certificate pack names the issuing laboratory and the standard behind each document, model by model. A report that does not name the laboratory is a template, and the red-flags page shows what one looks like.
Every document, and who issues each one- What happens if the shipment is held at the border?
Usually a classification or a labelling problem rather than a product problem, and both are fixable in days with the right paperwork. The guide walks the EU, UK and US borders in turn and names the document each one opens first.
What each border actually asks for
The other three sections
A question rarely belongs to exactly one decision. These are the neighbours.
Not answered here?
Send the question with your market and volume and you will have an answer within 24 hours, Monday to Friday. If we are not the right fit, we will say so.
Where these answers are worked through in full
Each section page answers; the pages below do the arithmetic, quote the standard and show the caveat.