Why certification belongs at the start
Plan certification when you define the product, before the first engineering build. Formal testing happens later, usually on production-representative units toward the end of DVT, but the decisions that make it pass or fail are made much earlier: target markets, radio design, battery, power supply, enclosure materials, PCB layout and even the space left for labels.
A late plan costs time in predictable ways. An emissions failure found at formal testing can mean a PCB respin. A battery pack without transport test reports cannot ship by air. A certificate issued in a supplier’s name can block a later change or a move to another factory. Because a product generally cannot be sold until the applicable approvals are in place, certification sits on the critical path to your ship date.
This page is general information, not legal or regulatory advice. Requirements change and depend on product details, so confirm them with an accredited lab or a regulatory specialist.
Common schemes by market
United States
- FCC radio certification. Products that intentionally transmit (Bluetooth, Wi-Fi, cellular and other radios) need FCC certification through a Telecommunication Certification Body, which results in an FCC ID.
- FCC digital device rules. Digital devices without a transmitter are usually authorized under the Supplier’s Declaration of Conformity procedure: testing is required, but no filing. The responsible party must be located in the United States. A product with a radio typically needs both routes covered.
- Lab recognition. Since 2025 the FCC has been withdrawing recognition from test labs and certification bodies it finds are owned or controlled by entities in certain countries, including some labs in mainland China, and it has consulted on going further. Confirm a lab’s current FCC recognition before booking, wherever it is located.
- Safety. Most consumer electronics have no single federal safety certification, but retailers, marketplaces, insurers and workplace rules commonly require listing by a Nationally Recognized Testing Laboratory (NRTL) to the relevant standard.
- Energy efficiency. External power supplies and battery chargers fall under federal efficiency rules, and California adds its own for some products.
European Union
CE marking is the manufacturer’s declaration that the product meets every EU law that applies to it. For electronics, the main ones are:
- Radio Equipment Directive (RED, 2014/53/EU) for any product with a radio. RED includes safety and EMC requirements, so a radio product is assessed under RED rather than separately under the EMC and Low Voltage Directives. Since August 2025, internet-connected radio equipment, and radio toys, childcare products and wearables that process personal data, must also meet RED cybersecurity requirements, with harmonized standards in the EN 18031 series.
- EMC Directive (2014/30/EU) for electronic products without a radio.
- Low Voltage Directive (LVD, 2014/35/EU) for equipment rated 50 to 1,000 V AC or 75 to 1,500 V DC, such as mains adapters. Lower-voltage consumer products fall outside the LVD; their safety is covered by the General Product Safety Regulation, which has applied since December 2024.
- RoHS (2011/65/EU), restricting hazardous substances in electrical and electronic equipment, is also part of the CE declaration.
Most products are self-declared by the manufacturer against harmonized standards. Under RED, a notified body is needed when harmonized standards are not applied in full, which has become more common with the cybersecurity requirements because some EN 18031 options do not give a presumption of conformity. The manufacturer keeps a technical file and an EU Declaration of Conformity, generally for 10 years after the product is placed on the market, and a manufacturer outside the EU needs an economic operator established in the EU, such as an importer or authorized representative.
Other EU rules add obligations, and some reach into the design: WEEE producer registration and marking, the EU Battery Regulation (which, from 2027, requires many portable batteries to be removable and replaceable by the user), and the common charger rules, which require USB-C charging on phones, headphones, portable speakers, keyboards and other listed product types.
United Kingdom
Great Britain has its own UKCA mark but has extended recognition of CE marking for most product rules, including electrical safety, EMC and radio equipment, so a CE-compliant product can often be sold there without separate UKCA testing. Northern Ireland follows EU rules. Check the current position for your category. Separately, since April 2024 the UK’s product security regime (PSTI) requires connectable consumer products to avoid universal default passwords, publish a way to report vulnerabilities and state a minimum period for security updates.
Other markets
Examples only; scope depends on the product.
| Market | Typical schemes for electronics |
|---|---|
| Canada | ISED radio certification; ICES-003 for digital devices; safety certification by an accredited body for mains-powered products |
| Japan | Radio certification under the Radio Act; PSE marking for many mains-powered products and AC adapters, and for some lithium-ion batteries |
| South Korea | KC certification for radio and EMC, and for electrical safety on listed products |
| Australia and New Zealand | RCM marking, with supplier registration |
| China, if selling there | CCC for listed product categories; SRRC type approval for radio equipment |
Safety standards and what they change in the design
Which safety standard applies depends on the product type:
- IEC 62368-1 covers audio/video and information and communication technology equipment and has replaced IEC 60950-1 and IEC 60065.
- IEC 60335-1, with a part 2 for the product type, covers household and personal-care appliances, for example IEC 60335-2-8 for shavers and hair clippers and IEC 60335-2-52 for oral hygiene appliances.
- IEC 61010-1 covers measurement, control and laboratory equipment. Machinery, including many robots, has its own rules; in the EU, the Machinery Regulation replaces the Machinery Directive from January 2027.
- Medical devices are a separate regulatory pathway (FDA in the US, the MDR in the EU, IEC 60601-1 for electrical safety). If your product makes medical claims, involve a regulatory specialist before the design is set.
These standards drive concrete design choices: creepage and clearance distances on mains circuits, enclosure plastics with the required flammability rating, temperature limits on surfaces people touch, battery protection circuits, and certified critical components such as power supplies, cells and fuses. Safety reports list the critical components, so substituting one later needs assessment first.
Batteries: UN 38.3 and IEC 62133
- UN 38.3 is the transport test for lithium cells and batteries, defined in the UN Manual of Tests and Criteria. It is a series of eight tests (T1 to T8) covering altitude, thermal cycling, vibration, shock, external short circuit, impact or crush, overcharge and forced discharge; not every test applies to every cell or battery. Lithium batteries must pass it before they can be shipped by air, sea or road under dangerous goods rules, including batteries packed with or installed in equipment, and a test summary must be available to the supply chain.
- Test the pack you will ship. A change of cell, protection circuit or pack construction generally needs new testing. The cell maker’s reports cover the cell, not your pack.
- IEC 62133-2 covers the safety of portable rechargeable lithium cells and batteries. Product safety standards, retailers and several national schemes commonly call for it, and North American programs may ask for UL 2054 or UL 62133-2.
- Shipping engineering units. Prototype and low-production batteries fall under stricter shipping provisions. Air rules cap lithium-ion batteries shipped alone at 30% state of charge, and since 2026 most batteries packed with, but not installed in, equipment. Check current rules with your forwarder before flying prototypes.
Choosing a test lab
- Accreditation to ISO/IEC 17025 with a scope that lists the exact standards and versions you need
- FCC recognition for the tests behind your certification, and a working route to a certification body
- CB test laboratory status if you will use the IECEE CB Scheme, where one safety test report supports national certificates in other member countries
- Access to an NRTL program or a notified body if your channel or an EU requirement needs one
- Pre-scan and debugging support from engineers who can diagnose a failure
- Chamber availability, realistic turnaround, and the cost and lead time of a retest
- Reports and certificates issued with your company as applicant or grantee
- A location near the factory, so samples and engineers can move quickly
Pre-scans
A pre-scan, or pre-compliance test, is an informal measurement on engineering units before formal testing. It costs a fraction of a formal test and finds problems while the layout can still change. Common pre-scans cover radiated and conducted emissions; electrostatic discharge around buttons, seams, connectors and exposed metal; radio output power and spurious emissions; and the temperature of hot components and touchable surfaces. Emissions problems often trace back to switching regulators, clock signals, unshielded cables and poor grounding between boards.
Radio testing needs test-mode firmware that can hold a fixed channel, transmit continuously and set output power. The ODM or module supplier usually provides it; ask for it at EVT, because missing test firmware is a common, avoidable delay.
Timing within EVT, DVT and PVT
| Phase | Certification work |
|---|---|
| Product definition | Target markets and channels; list of schemes and standards; module or discrete radio; battery cells and power supply with existing reports; label and manual space; lab booking and budget |
| EVT | Pre-scans on engineering units; safety design review (spacing, materials, temperatures); test-mode firmware available |
| DVT | Formal testing on production-representative units once the design is frozen; UN 38.3 on the final pack; applications filed; fix-and-retest loop |
| PVT | Production units checked against the tested configuration; labels, markings, manuals and declarations; certificates in hand before shipping |
| Mass production | Every change assessed for certification impact before approval; factory follow-up inspections where a safety mark requires them |
Formal testing often takes several weeks per scheme, and longer when a failure needs a design fix, so plan at least one failure-and-retest loop. After approval, changes are not free: in the US, some modifications can be filed as permissive changes while others need a new FCC ID, and EU documentation must be updated whenever a change affects compliance. How each build is run is covered in the EVT, DVT and PVT guide.
Splitting certification work with an OEM/ODM
| Task | Usual owner | Watch for |
|---|---|---|
| Target markets, claims, channel requirements | You, the brand | Retailers and marketplaces may ask for more than the law requires |
| List of applicable standards | You, with a lab or specialist; the ODM can advise | An ODM’s usual list may only cover the markets it normally sells into |
| Designing for compliance | Whoever owns the design: the ODM for its platform, your team for an OEM build | Put compliance responsibility in the development agreement |
| Test samples and test-mode firmware | The factory or ODM | Agree quantities and dates in the build plan |
| Test fees and retests | Negotiated, often within NRE | Who pays when a failure comes from the supplier’s design? |
| Certificate holder or FCC grantee | Ideally you | A certificate in the supplier’s name can block changes or a factory move |
| EU technical file and Declaration of Conformity | You, as the manufacturer when the product carries your brand; the supplier provides documentation | You need the technical file, not just a certificate |
| Production conformity | The factory, verified by you | Critical components must not change without approval |
When an ODM says a product “has CE” or “has FCC,” ask for the reports and check the model numbers covered, the standards and their versions, the lab, the date and the name on the certificate. Program certifications, such as Bluetooth SIG listing, Wi-Fi Alliance, Qi, Matter or Apple’s MFi program, are separate from regulatory approvals and carry their own fees and lead times.
Where Zefinity helps
Zefinity’s Develop work covers product definition and PRD review, where target markets and certification requirements should first be written down. Its Launch work covers NPI project management and supplier coordination, where certification samples and milestones are tracked with the OEM/ODM partner. Formal testing, certification and regulatory advice stay with accredited labs and qualified specialists.
Frequently asked questions
When should formal certification testing start?
Usually late in DVT, once the design is frozen and units are production-representative: final PCB, enclosure materials, antenna, battery pack and radio firmware. Testing earlier units risks repeating the work after changes. Pre-scans should start much earlier, at EVT, so problems are found while the design can still change at low cost.
If we use a pre-certified radio module, do we still need FCC and CE testing?
Yes. A module with its own approval reduces radio testing, but the finished product still needs its own compliance work, typically unintentional emissions, EMC, safety and RF exposure, and often some radio testing in the final housing. Your design must also meet the module approval's conditions, such as antenna type and gain.
Can we rely on our ODM's existing certificates?
Sometimes, as a starting point. Check that each report covers your exact model and configuration and uses current standard versions. When the product carries your brand, you usually take on the manufacturer's legal obligations, so you need access to the technical documentation and, ideally, certificates in your own company's name.