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Product Sourcing - Compliance12 min read

Product Compliance: CE, FCC, RoHS, UL and FDA Explained

Certification decides whether goods can be sold at all, and the papers are produced months before the shipment. Here is which mark applies where, who issues it, who pays and how to verify it.

Product Compliance: CE, FCC, RoHS, UL and FDA Explained

Most compliance failures are not discovered at the border. They are discovered in a quotation.

Buyers sourcing from China usually treat certification as paperwork that arrives with the shipment. In practice it decides whether the goods can legally be sold at all, and the documents that matter are produced months earlier, by the supplier, at a cost somebody has to pay. Getting the structure right before the first purchase order is considerably cheaper than correcting it after production.

This is the operational layer of the subject. For the wider picture of how compliance moved into the sourcing process during 2026, our analysis of China sourcing trends covers the shift itself. What follows is narrower: which mark applies to which market, who is allowed to issue it, who pays, and how to check that a document a supplier sends you is genuine.

Two Words That Should Not Be Used Interchangeably

The first thing to fix is vocabulary. Suppliers use these two terms loosely, and the difference decides who carries the legal risk.

  • · Certification: an assessment performed by a body independent of the manufacturer, resulting in a document issued in that body's name
  • · Declaration: a document the manufacturer or importer signs on its own responsibility, stating that the product meets the applicable rules
  • · Why the difference matters: a declaration has no external issuer to point at, so the party that signed it absorbs the consequences if the product turns out not to comply
  • · What buyers usually receive: a mixture of both, delivered in one folder, formatted to look equally official

Knowing which of the two you are holding changes what you do next. A certification can be verified at the issuer. A declaration can only be checked against the technical file behind it.

CE Marking: A Manufacturer's Declaration, Not a Certificate

The CE mark is the clearest example of the confusion. There is no central European body that grants it and no certificate you can buy from an authority.

  • · Who is responsible: the manufacturer, which under EU rules includes a company that has a product made for it and sells it under its own name or brand
  • · What has to be done: identify every applicable EU requirement, decide whether self-assessment is permitted, assemble the technical documentation, then draft and sign an EU Declaration of Conformity
  • · What the mark itself costs: nothing. The mark carries no fee, but the conformity assessment behind it is paid for by the party placing the product on the market
  • · How long the file must be kept: the declaration and the supporting technical documentation are retained for at least 10 years after the product is placed on the market
  • · How the mark must look: the letters CE at equal vertical height, at least 5 mm, visible, legible and indelible, ideally on the product itself

The practical consequence is that a Chinese factory cannot hand you a CE certificate that resolves your obligation. The declaration is signed by the manufacturer, and if you sell under your own brand, in EU terms you are the manufacturer.

When a Notified Body Is Genuinely Required

A notified body is an independent organisation authorised by an EU country to assess products where legislation does not permit full self-assessment. It is not a general-purpose certifier you engage for reassurance.

  • · Typical categories: higher-risk products such as medical devices, construction products and machinery
  • · How to confirm: read the conformity assessment procedure in the applicable EU legislation for your product, not a supplier's summary of it
  • · What appears on the product: if a notified body was used, its four-digit identification number must appear next to the CE marking
  • · Where to check authorisation: the European Commission maintains the NANDO database of notified bodies, searchable by legislation and product category

If a supplier claims a notified body was involved, the four-digit number next to the mark is the claim you can test in that database in about two minutes.

How to Tell a Real CE File from a Decorative One

The European Commission itself warns about organisations issuing voluntary certificates that are not legally recognised for CE marking.

  • · The warning is specific: such documents may be issued without any product testing, may cover areas outside the body's legal competence, and may mislead both customers and regulators
  • · What a genuine file contains: an EU Declaration of Conformity naming the manufacturer, the product and the directives applied, backed by test reports and technical documentation
  • · What a decorative file contains: a certificate-shaped page with a logo, a reference number and no traceable test data
  • · The one-line test: ask which directive or regulation the document addresses. A real file answers that immediately; a decorative one tends to answer with the name of the certificate rather than the law

RoHS: The Restriction That Sits Underneath the CE Mark

RoHS is often presented as a standalone certificate. In the European Union it is a directive that electrical and electronic equipment has to satisfy before the CE mark can be applied at all.

  • · Scope: all products with an electrical or electronic component, unless specifically excluded
  • · Restricted substances: ten in total, being lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers, and four phthalates known as DEHP, BBP, DBP and DIBP
  • · Threshold: generally 0.1 percent by weight in a homogeneous material, with cadmium restricted at 0.01 percent
  • · Exemptions: time-limited exemptions exist for applications where no substitute is currently available, and they are revised periodically, so an exemption cited in an old file may no longer be valid
  • · Where the burden falls: on the homogeneous material, not the finished product, which is why component-level sourcing decisions determine the result

A supplier who says the product is RoHS compliant is describing a conclusion. The document worth having is a test report that identifies which materials were tested and against which limits.

FCC: Two Routes, and Only One Produces an FCC ID

In the United States the FCC runs two approval procedures, and they apply to different kinds of equipment.

  • · Certification: the more rigorous route, used for devices with the greatest potential to cause harmful interference
  • · Who issues it: an FCC-recognised Telecommunication Certification Body, acting on documentation and test data submitted by the responsible party
  • · Who tests: an FCC-recognised accredited testing laboratory
  • · What you get: an FCC ID, and an entry for the equipment in a Commission-maintained public database
  • · What triggers it: an intentional radiator, meaning a device that transmits, such as a radio transmitter

Digital circuitry without a transmitter follows the other route. Computer peripherals, microwave ovens, switching power supplies, LED light bulbs and radio receivers are approved by the simpler process, which may optionally be upgraded to certification.

Products that both transmit and contain digital circuitry need both treatments. A phone, a wireless access point, a notebook or a tablet is a combination device, and the file has to reflect that.

The Responsible Party Must Be in the United States

This is the detail that catches importers, and it is stated plainly in the FCC's own description of the procedure.

  • · The rule: under the Supplier's Declaration of Conformity route, the party responsible for compliance must be located in the United States
  • · What is not filed: no equipment authorisation application goes to the Commission or to a certification body
  • · What is not created: the equipment is not listed in the Commission database, so there is no public entry to point a buyer towards
  • · What remains: the responsible party must be able to produce a test report and supporting information on request by the Commission
  • · The practical implication: a factory in China cannot be the responsible party for this route, whatever it states on the paperwork

How to Check an FCC Claim

  • · If the device transmits, ask for the FCC ID and confirm the entry exists in the Commission's public equipment database
  • · If the device only contains digital circuitry, ask for the test report and the identity of the US responsible party named in the declaration
  • · If a supplier offers an FCC certificate with no ID and no named US party on a transmitting product, the file is incomplete

UL and the NRTL System: Voluntary on Paper, Required in Practice

UL is the best-known name in this group and the least well understood. It is not a government mark, and in most consumer electronics categories it is not a legal prerequisite.

  • · What an NRTL is: a private-sector organisation recognised by the US Occupational Safety and Health Administration to perform certification for certain products
  • · What OSHA is not: OSHA recognises testing laboratories but is not itself one
  • · Why UL still matters: major retailers and marketplaces require safety certification before they will list a product, so the commercial requirement arrives before any legal one
  • · The relevant standard: UL 62368-1 covers audio and video and information technology equipment, replacing the older split between 60950 and 60065
  • · How to verify a claim: UL maintains a public certification database searchable by company name or by the file number printed on the label

A UL file number beginning with E, checked in that directory, tells you more than any PDF a supplier can produce.

What Changes in February 2027

The fourth edition of the UL and CSA 62368-1 standard becomes the required basis for certification on 15 February 2027. Files certified to the previous edition will need to move.

  • · What it means for a 2026 order: a certificate issued against the outgoing edition has a known expiry horizon
  • · What to ask a supplier: which edition of 62368-1 the current file was issued against, and whether a transition is already planned
  • · Why it matters at resale: a product whose certification lapses in early 2027 can become unlistable on some channels without any change to the product itself

FDA: The Category Most Buyers Do Not Realise They Are In

The FDA is usually associated with food, drugs and medical devices. Its radiation control programme is broader than most importers expect, and it carries reporting obligations that fall due before shipping.

  • · Products in scope include: diagnostic x-ray systems, laser products, laser light shows, microwave ovens, cabinet x-ray systems, sunlamps and sunlamp products, mercury vapour lamps, germicidal ultraviolet lamps, light emitting diodes, and people scanners
  • · The regulations: 21 CFR Parts 1000 through 1040, with mandatory radiation safety performance standards in Parts 1020 to 1040
  • · Who counts as a manufacturer: any person engaged in manufacturing, assembling or importing these products, so the importer is captured by the definition
  • · What must be submitted: a product report, supplemental report or abbreviated report, submitted before the product enters interstate commerce
  • · Timing for imports: reports should be sent at least one month before the goods are presented for import, which allows the agency to issue an acknowledgement letter containing an accession number
  • · Recurring obligation: an annual report is due each year by 1 September, covering the twelve months ending 30 June

That accession number is the verification hook. It identifies the report on file for that product, and it is issued by the agency rather than by the supplier.

The Documents to Ask For, Market by Market

The practical version of everything above is a short list attached to the first quotation.

  • · European Union: EU Declaration of Conformity naming the manufacturer and the directives applied, plus the technical file and, where the CE mark is required, evidence of the applicable conformity assessment
  • · European Union, electronics: the RoHS test report identifying tested materials and limits
  • · United States, transmitting devices: FCC ID and confirmation the entry appears in the public equipment database
  • · United States, digital-only devices: test report plus the identity of the US responsible party
  • · United States, retail-bound electronics: current safety certification with the file number, checked against the issuer's directory
  • · United States, radiation-emitting products: FDA accession number from the acknowledgement letter, with the annual report kept current
  • · Universal: component-level material declarations, because RoHS compliance is decided at the material level rather than at assembly

Ask for these with the first quotation rather than with the shipping documents. A supplier that can produce them early is describing a product that already exists in compliant form, and one that cannot is describing a project.

Who Actually Pays for Certification

Certification costs land somewhere, and the negotiation is about where.

  • · Testing: paid by whoever commissions it, which is normally the factory and then recovered in the unit price
  • · Notified body assessment: paid by the party placing the product on the market, and only where legislation requires third-party assessment
  • · Ongoing obligations: annual reports and recertification carry recurring costs that are easy to omit from a first-year budget
  • · The cheapest change: deciding the target market before tooling, since a product built for one market's requirements is rarely the cheapest one to convert later

The cost of compliance is best treated as part of the landed cost of the product, alongside freight and duty, rather than as a one-off project fee.

Before committing to a specification, it is worth confirming where the paper trail will come from. Our sourcing and purchasing service handles that question as part of the supplier selection process, and pairs it with pre-shipment inspection so the goods that ship match the file that was approved.

What Is Arriving Next: The Digital Product Passport

The compliance file is in the process of becoming a digital record attached to the product itself.

  • · What it is: a Digital Product Passport is a digital container holding product, component and material information across the lifecycle
  • · Legal basis: the Ecodesign for Sustainable Products Regulation, with product-specific requirements set by delegated acts or by separate legislation
  • · Current status: the European DPP Registry became operational on 20 July 2026
  • · First deadline: the passport becomes mandatory for certain types of batteries on 18 February 2027, covering electric vehicle, light means of transport and industrial batteries
  • · Rolling coverage: iron and steel, then textiles, tyres and aluminium, then furniture, with mattresses and information and communication technology products listed for 2029
  • · Transition: economic operators get at least 18 months after a delegated act is adopted before the requirement applies

For most consumer electronics categories this is a 2027 to 2029 horizon rather than a next-quarter problem. The reason to track it now is that the data has to come from the supply chain, and assembling it retrospectively is harder than collecting it as you go.

FAQ

Is a CE certificate the same as a CE marking?

No. The CE marking is applied by the manufacturer, who signs an EU Declaration of Conformity and keeps the supporting technical documentation. There is no central EU body that issues a certificate permitting its use.

Can my Chinese supplier sign the FCC declaration for me?

Not if the device follows the Supplier's Declaration of Conformity route. That procedure requires the responsible party to be located in the United States, so the declaration has to come from a US entity.

Do I need UL certification to sell electronics in the United States?

It is generally not a legal requirement for consumer electronics, but major retailers and marketplaces require safety certification before listing. In practice the commercial gate is the binding one.

How long do I have to keep compliance documents?

For products under EU rules, the declaration of conformity and the technical documentation must be retained for at least 10 years after the product is placed on the market. Under the FDA radiation control programme, reporting is annual and ongoing rather than retained and forgotten.

Does any of this change if I import appliances rather than electronics?

Yes, because appliances add requirements that electronics do not carry. Voltage and frequency, energy label registration and refrigerant rules are covered in our guide to importing home appliances from China.

Where This Leaves Your Next Order

Certification is not a document you collect at the end of a project. It is a set of constraints that determines what can be built, for which market, at what cost, and it is cheapest to settle before the specification is frozen.

  • · Fix the target market first, then the product specification, then the supplier
  • · Ask for compliance files with the first quotation, not with the shipping documents
  • · Verify every claim at the issuer: a notified body number, an FCC ID, a file number, an accession number
  • · Treat certification as part of landed cost rather than as a project expense
  • · Diary the expiry dates, especially where a standard transitions

The buyers who get this right are not the ones with the largest compliance budget. They are the ones who asked the question in the right order, at the point where changing course was still free. To work through that sequence for your own category, contact our team before the next specification is locked.