{ "$comment": "srvo Certification Map rules. Engine: src/scripts/tools/certification-model.ts. Served raw at /tools/cert-rules.json. EDITING: each rule fires when its market is selected (\"global\" = any market) AND its `when` matches the input tokens: when.all = every token present; when.any = at least one present; when.not = none present. `level` is the default; `levels[]` overrides it, first match wins, and its `note` is appended to `because`. steps: design | pre (pre-compliance) | test (formal) | file (filings & marking) — drives the timeline strip. cost/lead are null unless an OFFICIAL source publishes them. Every rule needs >=1 https source; prefer primary text (eCFR, EUR-Lex, ISED, legislation.gov.uk, ACMA, METI). Sources were fetched and checked on the `updated` date; `reviewed` flips to an engineer's name/date after owner review. Run `node tests/tools.test.mjs` after any edit.", "meta": { "version": "1.0", "updated": "2026-10-21", "reviewed": "pending", "disclaimer": "This is a planning aid, not legal or compliance advice. It can't see every detail of your design, and the rules change. Confirm the final list with an accredited test lab, and with regulatory counsel for medical, children's and food-contact products." }, "markets": [ { "id": "us", "code": "US", "label": "United States" }, { "id": "ca", "code": "CA", "label": "Canada" }, { "id": "eu", "code": "EU", "label": "European Union" }, { "id": "uk", "code": "UK", "label": "United Kingdom" }, { "id": "au", "code": "ANZ", "label": "Australia / NZ" }, { "id": "jp", "code": "JP", "label": "Japan" }, { "id": "global", "code": "ALL", "label": "All markets" } ], "tokens": { "m:us": "US", "m:ca": "Canada", "m:eu": "EU", "m:uk": "UK", "m:au": "Australia/NZ", "m:jp": "Japan", "p:ac": "mains AC", "p:usb": "USB power", "p:li": "Li-ion battery", "p:primary": "primary battery", "r:wifi": "Wi-Fi", "r:ble": "Bluetooth", "r:cell": "cellular", "r:lora": "LoRa", "r:nfc": "NFC", "r:zigbee": "Zigbee/Thread", "radio": "has a radio", "battery": "battery", "electronic": "electronics", "multi": "several markets", "f:wear": "worn on body", "f:child": "children's product", "f:food": "food contact", "f:medical": "medical claims", "f:wet": "outdoor/wet use", "f:magnet": "magnets", "f:laser": "laser/IR" }, "rules": [ { "id": "us-fcc-15b", "market": "us", "name": "FCC Part 15 Subpart B: unintentional radiator", "short": "FCC 15B", "what": "Limits the radio-frequency noise from your product's digital circuitry. Almost anything with a clock or a processor counts as a digital device. Most consumer products are authorized by Supplier's Declaration of Conformity (SDoC): an accredited-lab test report, records kept, a compliance statement on the label or in the manual, and no FCC filing.", "because": "Your product has digital electronics and will be sold in the US.", "when": { "all": [ "m:us", "electronic" ] }, "level": "required", "steps": [ "pre", "test", "file" ], "cost": null, "lead": null, "tip": "Producers on the FCC Covered List can't use SDoC and must certify instead (47 CFR 2.906, amended Aug 2025). A few device types are exempt under §15.103; check before assuming yours is.", "sources": [ { "label": "47 CFR Part 15 Subpart B (eCFR)", "url": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-B" }, { "label": "47 CFR 15.101: equipment authorization table", "url": "https://www.ecfr.gov/current/title-47/section-15.101" }, { "label": "47 CFR 2.906: Supplier's Declaration of Conformity", "url": "https://www.ecfr.gov/current/title-47/section-2.906" } ] }, { "id": "us-fcc-15c", "market": "us", "name": "FCC Part 15 Subpart C: intentional radiator (certification)", "short": "FCC 15C + FCC ID", "what": "Rules for licence-exempt transmitters such as Wi-Fi, Bluetooth, LoRa (902–928 MHz), Zigbee/Thread and NFC. Most need certification: an accredited lab tests the radio, and a Telecommunication Certification Body (TCB) issues a grant and an FCC ID before you market the product.", "because": "Your product has a licence-exempt radio and will be sold in the US.", "when": { "all": [ "m:us" ], "any": [ "r:wifi", "r:ble", "r:lora", "r:nfc", "r:zigbee" ] }, "level": "required", "steps": [ "pre", "test", "file" ], "cost": null, "lead": null, "tip": "A pre-certified module carries its own FCC ID (§15.212). Follow its integration conditions and label your product \"Contains FCC ID: …\", and you usually avoid certifying the radio again. Your product still needs its own Part 15B compliance.", "sources": [ { "label": "47 CFR Part 15 Subpart C (eCFR)", "url": "https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-C" }, { "label": "47 CFR 15.201: equipment authorization of intentional radiators", "url": "https://www.ecfr.gov/current/title-47/section-15.201" }, { "label": "47 CFR 15.212: modular transmitters", "url": "https://www.ecfr.gov/current/title-47/section-15.212" }, { "label": "47 CFR 15.247: 902–928, 2400–2483.5, 5725–5850 MHz", "url": "https://www.ecfr.gov/current/title-47/section-15.247" }, { "label": "47 CFR 2.907: certification", "url": "https://www.ecfr.gov/current/title-47/section-2.907" } ] }, { "id": "us-fcc-cell", "market": "us", "name": "FCC licensed-radio rules for cellular (Parts 22, 24, 27)", "short": "FCC cellular", "what": "Cellular transmitters operate under the licensed-service rule parts (Part 22 cellular, Part 24 PCS, Part 27 and others by band) and need FCC certification. Most startups use a pre-certified cellular module and rely on its grant.", "because": "Your product has a cellular radio and will be sold in the US.", "when": { "all": [ "m:us", "r:cell" ] }, "level": "required", "steps": [ "test", "file" ], "cost": null, "lead": null, "sources": [ { "label": "47 CFR Part 22 (eCFR)", "url": "https://www.ecfr.gov/current/title-47/part-22" }, { "label": "47 CFR Part 24 (eCFR)", "url": "https://www.ecfr.gov/current/title-47/part-24" }, { "label": "47 CFR Part 27 (eCFR)", "url": "https://www.ecfr.gov/current/title-47/part-27" } ] }, { "id": "us-ptcrb", "market": "us", "name": "Carrier acceptance (PTCRB and carrier testing)", "short": "PTCRB / carrier", "what": "Before a cellular device goes on a network, operators run their own acceptance. PTCRB certification is the common route in North America: its participating operators include AT&T, T-Mobile, Verizon, Rogers and Telus, and some add their own testing.", "because": "Your product connects to a cellular network.", "when": { "all": [ "m:us", "r:cell" ] }, "level": "likely", "steps": [ "test", "file" ], "cost": null, "lead": null, "tip": "Ask your carrier or MVNO which approvals they require before you choose a module. A module that already holds carrier approvals saves the most time.", "sources": [ { "label": "PTCRB: about and participating operators", "url": "https://www.ptcrb.com/about/" }, { "label": "PTCRB: get certified", "url": "https://www.ptcrb.com/get-certified/" } ] }, { "id": "us-rf-exposure", "market": "us", "name": "RF exposure evaluation (SAR / MPE)", "short": "RF exposure", "what": "Every transmitter must show it keeps human RF exposure within FCC limits, either through an exemption or an evaluation. Devices used within 20 cm of the body are \"portable\" and, above the exemption thresholds, need a SAR evaluation (§2.1093).", "because": "Your product transmits radio energy.", "when": { "all": [ "m:us", "radio" ] }, "level": "likely", "levels": [ { "when": { "all": [ "f:wear" ] }, "level": "required", "note": "It's worn on the body, so it's a portable device (used within 20 cm), which usually means SAR testing." } ], "steps": [ "test", "file" ], "cost": null, "lead": null, "sources": [ { "label": "47 CFR 2.1093: portable devices", "url": "https://www.ecfr.gov/current/title-47/section-2.1093" }, { "label": "47 CFR 1.1307: exemption thresholds", "url": "https://www.ecfr.gov/current/title-47/section-1.1307" }, { "label": "47 CFR 1.1310: exposure limits", "url": "https://www.ecfr.gov/current/title-47/section-1.1310" } ] }, { "id": "us-nrtl", "market": "us", "name": "Product safety listing to UL 62368-1 (NRTL)", "short": "UL/ETL 62368-1", "what": "UL/IEC 62368-1 is the hazard-based safety standard for audio/video and information and communication technology equipment (IEC 62368-1:2023, Edition 4). A listing from an OSHA-recognized lab (NRTL: UL, Intertek ETL, CSA and others) is the norm for US market access.", "because": "No general federal law requires it for consumer products, but OSHA requires approved (in practice, NRTL-listed) electrical equipment in workplaces, and retailers, insurers and commercial buyers commonly ask for a listing.", "when": { "all": [ "m:us", "electronic" ] }, "level": "maybe", "levels": [ { "when": { "any": [ "p:ac" ] }, "level": "likely", "note": "It plugs into the mains, where most of the shock and fire risk sits." } ], "steps": [ "pre", "test", "file" ], "cost": null, "lead": null, "tip": "62368-1 covers AV and ICT products. Household appliances, lab instruments, toys and medical devices use other standards (for example IEC 60335, 61010 or 60601); your lab will confirm which applies.", "sources": [ { "label": "OSHA: NRTL program", "url": "https://www.osha.gov/nationally-recognized-testing-laboratory-program" }, { "label": "OSHA: products requiring NRTL approval", "url": "https://www.osha.gov/nationally-recognized-testing-laboratory-program/products-requiring-approval" }, { "label": "29 CFR 1910.303: electrical equipment must be approved", "url": "https://www.ecfr.gov/current/title-29/section-1910.303" }, { "label": "IEC 62368-1:2023 (IEC webstore)", "url": "https://webstore.iec.ch/publication/69308" } ] }, { "id": "us-cpsia", "market": "us", "name": "CPSIA children's product rules (Children's Product Certificate)", "short": "CPSIA + CPC", "what": "Products designed or intended primarily for children 12 and under need a Children's Product Certificate based on testing by a CPSC-accepted third-party lab: lead in substrate (100 ppm) and in paint (90 ppm), phthalates (16 CFR 1307), ASTM F963-23 if it's a toy (16 CFR 1250), plus permanent tracking labels.", "because": "You marked it as a product for children under 12.", "when": { "all": [ "m:us", "f:child" ] }, "level": "required", "steps": [ "design", "test", "file" ], "cost": null, "lead": null, "tip": "Lead and phthalates are material choices, not test fixes: pick materials with test data early. Since July 8, 2026, importers must eFile certificate data with CBP for regulated products.", "sources": [ { "label": "CPSC: Children's Product Certificate", "url": "https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Childrens-Product-Certificate" }, { "label": "CPSC: third-party testing", "url": "https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Third-Party-Testing" }, { "label": "CPSC: tracking labels", "url": "https://www.cpsc.gov/FAQ/Tracking-Label" }, { "label": "16 CFR Part 1250: toy safety (ASTM F963)", "url": "https://www.ecfr.gov/current/title-16/part-1250" }, { "label": "CPSC: mandatory eFiling (2026)", "url": "https://www.cpsc.gov/Newsroom/News-Releases/2026/CPSC-Implements-Mandatory-eFiling-for-Certificates-of-Compliance-Targeting-Dangerous-Foreign-Imports" } ] }, { "id": "us-reese", "market": "us", "name": "Button and coin batteries (Reese's Law, 16 CFR 1263)", "short": "Reese's Law", "what": "Consumer products that contain or come with button or coin cells must have child-resistant battery compartments and warnings meeting ANSI/UL 4200A-2023. Applies to products made or imported on or after Oct 23, 2023; package warnings apply from Sept 21, 2024. Toys that comply with 16 CFR 1250 are exempt, and zinc-air cells are excluded.", "because": "It applies if your primary battery is a button or coin cell (a CR2032, for example).", "when": { "all": [ "m:us", "p:primary" ] }, "level": "maybe", "steps": [ "design", "test" ], "cost": null, "lead": null, "sources": [ { "label": "CPSC: button cell and coin battery guidance", "url": "https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Button-Cell-and-Coin-Battery" }, { "label": "16 CFR Part 1263 (eCFR)", "url": "https://www.ecfr.gov/current/title-16/part-1263" } ] }, { "id": "us-magnets", "market": "us", "name": "Hazardous magnets (16 CFR 1262)", "short": "16 CFR 1262", "what": "Products for entertainment, jewelry, mental stimulation or stress relief that contain loose small magnets (small enough to fit the small-parts cylinder, flux index of 50 kG²·mm² or more) must meet the CPSC magnet standard. Toys are covered by the toy standard instead.", "because": "Your product contains magnets.", "when": { "all": [ "m:us", "f:magnet" ] }, "level": "maybe", "levels": [ { "when": { "all": [ "f:child" ] }, "level": "likely", "note": "For a toy, the magnet requirements in ASTM F963 (via 16 CFR 1250) apply instead." } ], "steps": [ "design", "test" ], "cost": null, "lead": null, "sources": [ { "label": "CPSC: magnets business guidance", "url": "https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Magnets" }, { "label": "16 CFR Part 1262 (eCFR)", "url": "https://www.ecfr.gov/current/title-16/part-1262" } ] }, { "id": "us-fda", "market": "us", "name": "FDA medical device rules (classify first)", "short": "FDA device", "what": "If your intended use or claims involve diagnosing, treating, mitigating or preventing disease, the product is likely a medical device under FD&C Act 201(h). Its class sets the path: many Class I devices are exempt from premarket review, and most Class II devices need a 510(k). Low-risk products may fall under FDA's General Wellness policy, revised in January 2026.", "because": "You marked medical or health claims.", "when": { "all": [ "m:us", "f:medical" ] }, "level": "required", "steps": [ "design", "test", "file" ], "cost": { "text": "510(k) user fee for FY2027 (from Oct 1, 2026): $28,653 standard, $7,163 for qualifying small businesses. Annual establishment registration: $13,785.", "source": { "label": "FDA: MDUFA fees", "url": "https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees" } }, "lead": { "text": "FDA's review goal for a 510(k) is 90 FDA days; the clock stops while FDA waits on answers from you.", "source": { "label": "FDA: 510(k) submission process", "url": "https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process" } }, "tip": "Your claims set your class. Write the intended-use statement and marketing copy with a regulatory consultant before you design, not after.", "sources": [ { "label": "FDA: how to determine if your product is a medical device", "url": "https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device" }, { "label": "FDA: classify your medical device", "url": "https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device" }, { "label": "FDA: General Wellness guidance (2026)", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices" } ] }, { "id": "us-laser", "market": "us", "name": "FDA laser product standard (21 CFR 1040.10)", "short": "FDA laser", "what": "Products containing a laser must be classified (Class I to IV) and meet the federal performance standard: labels and safety features, plus a product report filed with FDA's CDRH before the product enters commerce. FDA accepts conformance with IEC 60825-1 Ed. 3 under Laser Notice 56.", "because": "You marked a laser or IR emitter. This applies to lasers, including VCSELs; plain LEDs fall under lamp-safety standards instead.", "when": { "all": [ "m:us", "f:laser" ] }, "level": "likely", "steps": [ "design", "test", "file" ], "cost": null, "lead": null, "sources": [ { "label": "21 CFR 1040.10: laser products", "url": "https://www.ecfr.gov/current/title-21/section-1040.10" }, { "label": "21 CFR 1002.10: product reports", "url": "https://www.ecfr.gov/current/title-21/section-1002.10" }, { "label": "FDA: Laser Notice 56 (IEC 60825-1 Ed. 3)", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-conformance-iec-60825-1-ed-3-and-iec-60601-2-22-ed-31-laser-notice-no-56" } ] }, { "id": "us-prop65", "market": "us", "name": "California Proposition 65 warnings", "short": "Prop 65", "what": "If a product sold in California can expose people to a listed chemical (lead in brass or solder, some PVC plasticizers, BPA and others), it needs a \"clear and reasonable\" warning. Businesses with fewer than 10 employees are exempt.", "because": "It can apply to any consumer product sold into California, depending on its materials.", "when": { "all": [ "m:us" ] }, "level": "maybe", "steps": [ "design", "file" ], "cost": null, "lead": null, "sources": [ { "label": "OEHHA: Proposition 65 FAQs", "url": "https://oehha.ca.gov/proposition-65/general-info/proposition-65-faqs" } ] }, { "id": "us-food-contact", "market": "us", "name": "FDA food-contact materials (21 CFR 174–178)", "short": "FDA food contact", "what": "Materials that touch food must be cleared for that use: generally recognized as safe, prior-sanctioned, listed in the indirect food additive regulations (21 CFR 174–178), or covered by an effective Food Contact Notification. Ask your resin and coating suppliers for compliance letters.", "because": "You marked food contact.", "when": { "all": [ "m:us", "f:food" ] }, "level": "required", "steps": [ "design", "file" ], "cost": null, "lead": null, "sources": [ { "label": "21 CFR 174.5 (eCFR)", "url": "https://www.ecfr.gov/current/title-21/section-174.5" }, { "label": "FDA: packaging and food contact substances", "url": "https://www.fda.gov/food/food-ingredients-packaging/packaging-food-contact-substances-fcs" } ] }, { "id": "us-doe", "market": "us", "name": "DOE efficiency: external power supplies and battery chargers", "short": "DOE EPS / charger", "what": "If you ship a wall adapter (external power supply) or a battery charger with the product, it must meet DOE efficiency standards under 10 CFR 430.32: Level VI for power supplies, unit-energy-consumption limits for battery chargers. DOE proposed rescinding both in May 2025; until a final rule says otherwise, they still apply.", "because": "You selected mains AC, USB or a rechargeable battery; this applies if the box includes an adapter or charger.", "when": { "all": [ "m:us" ], "any": [ "p:ac", "p:usb", "p:li" ] }, "level": "maybe", "steps": [ "design", "file" ], "cost": null, "lead": null, "sources": [ { "label": "DOE: external power supplies", "url": "https://www.energy.gov/cmei/buildings/external-power-supplies" }, { "label": "DOE: battery chargers", "url": "https://www.energy.gov/cmei/buildings/battery-chargers" }, { "label": "10 CFR 430.32 (eCFR)", "url": "https://www.ecfr.gov/current/title-10/section-430.32" } ] }, { "id": "ca-ices003", "market": "ca", "name": "ICES-003: digital apparatus emissions", "short": "ICES-003", "what": "Canada's emissions standard for IT equipment and digital apparatus (Issue 7). It's self-declared: test to CISPR 32 or ANSI C63.4, usually alongside FCC Part 15B, and label the product \"CAN ICES-003(B)/NMB-003(B)\".", "because": "Your product has digital electronics and will be sold in Canada.", "when": { "all": [ "m:ca", "electronic" ] }, "level": "required", "steps": [ "pre", "test", "file" ], "cost": null, "lead": null, "sources": [ { "label": "ISED: ICES-003", "url": "https://ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/interference-causing-equipment-standards-ices/ices-003-information-technology-equipment-including-digital-apparatus" } ] }, { "id": "ca-ised", "market": "ca", "name": "ISED radio certification (RSS-Gen, band RSS, RSS-102)", "short": "ISED + IC number", "what": "Radio apparatus needs certification through an ISED-recognized certification body, tested to RSS-Gen plus the band standard (RSS-247 for Wi-Fi and Bluetooth, RSS-210 for other licence-exempt devices, or the cellular RSSs) and RSS-102 for RF exposure. The label shows \"IC: XXXXX-YYYYYYYYYYY\".", "because": "Your product has a radio and will be sold in Canada.", "when": { "all": [ "m:ca", "radio" ] }, "level": "required", "steps": [ "pre", "test", "file" ], "cost": null, "lead": null, "tip": "RSS-Gen Issue 6 took effect on July 30, 2026 (amended Sept 15, 2026) with a one-year transition, so plan new certifications against Issue 6. A module with its own IC number can be reused, much like an FCC modular grant.", "sources": [ { "label": "ISED: RSS-Gen", "url": "https://ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/radio-equipment-standards/radio-standards-specifications-rss/rss-gen-general-requirements-compliance-radio-apparatus" }, { "label": "ISED: RSS-210", "url": "https://ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/radio-equipment-standards/radio-standards-specifications-rss/rss-210-licence-exempt-radio-apparatus-category-i-equipment" }, { "label": "ISED: RSS-102 (RF exposure)", "url": "https://ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/radio-equipment-standards/radio-standards-specifications-rss/rss-102-radio-frequency-rf-exposure-compliance-radiocommunication-apparatus-all-frequency-bands" }, { "label": "ISED: wireless certification program", "url": "https://ised-isde.canada.ca/site/certification-engineering-bureau/en/wireless-program" } ] }, { "id": "ca-safety", "market": "ca", "name": "Electrical safety certification (CSA, cUL, cETL)", "short": "CSA / cUL", "what": "Provincial electrical codes require electrical products to be approved by an accredited certification body before they're sold, displayed or advertised (Canadian Electrical Code Rule 2-024). Recognized marks include CSA, cUL, cETL (Intertek), Nemko, TÜV Rheinland and QPS.", "because": "Products that connect to the electrical supply need an approval mark in Canada.", "when": { "all": [ "m:ca", "electronic" ] }, "level": "maybe", "levels": [ { "when": { "any": [ "p:ac" ] }, "level": "required", "note": "It plugs into the mains." } ], "steps": [ "test", "file" ], "cost": null, "lead": null, "sources": [ { "label": "Electrical Safety Authority (Ontario): electrical products", "url": "https://esasafe.com/electrical-products/" }, { "label": "ESA: recognized certification marks", "url": "https://esasafe.com/electrical-products/recognized-certification-marks/" } ] }, { "id": "ca-toys", "market": "ca", "name": "Canada Consumer Product Safety Act + Toys Regulations", "short": "CCPSA toys", "what": "Toys and other products for children must meet the Toys Regulations (SOR/2011-17) under the Canada Consumer Product Safety Act, covering small parts, magnets, lead, phthalates, electrical toys and more.", "because": "You marked a children's product sold in Canada.", "when": { "all": [ "m:ca", "f:child" ] }, "level": "required", "steps": [ "design", "test" ], "cost": null, "lead": null, "sources": [ { "label": "Toys Regulations SOR/2011-17", "url": "https://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/index.html" }, { "label": "Canada Consumer Product Safety Act", "url": "https://laws-lois.justice.gc.ca/eng/acts/C-1.68/" } ] }, { "id": "ca-labels", "market": "ca", "name": "Bilingual labelling (Consumer Packaging and Labelling Act)", "short": "EN/FR labels", "what": "Prepackaged consumer products need their mandatory label information (product identity, net quantity, dealer name and address) in both English and French, with some exemptions.", "because": "You'll sell a consumer product in Canada.", "when": { "all": [ "m:ca" ] }, "level": "likely", "steps": [ "file" ], "cost": null, "lead": null, "sources": [ { "label": "Consumer Packaging and Labelling Act", "url": "https://laws-lois.justice.gc.ca/eng/acts/C-38/" }, { "label": "Consumer Packaging and Labelling Regulations", "url": "https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._417/index.html" } ] }, { "id": "gl-un383", "market": "global", "name": "UN 38.3 transport testing (lithium cells and batteries)", "short": "UN 38.3", "what": "Lithium cells and batteries must be of a type that passed the UN Manual of Tests and Criteria, Part III, sub-section 38.3 (altitude, thermal, vibration, shock, external short circuit and more) before they can be shipped, and a test summary must be made available. In the US this is 49 CFR 173.185.", "because": "Lithium cells, rechargeable or lithium-metal primaries like coin cells, are regulated as dangerous goods in transport.", "when": { "any": [ "p:li", "p:primary" ] }, "level": "maybe", "levels": [ { "when": { "all": [ "p:li" ] }, "level": "required", "note": "Your product contains a Li-ion battery." }, { "when": { "all": [ "p:primary" ] }, "level": "maybe", "note": "It applies if your primary cell is lithium metal (a CR2032, for example). Alkaline cells aren't covered." } ], "steps": [ "test", "file" ], "cost": null, "lead": null, "tip": "Get the UN 38.3 test summary from your cell or pack supplier. A custom pack needs its own test. US marking rules changed recently: watt-hour marking is required, and old lithium marks are allowed only until Dec 31, 2026.", "sources": [ { "label": "49 CFR 173.185: lithium cells and batteries", "url": "https://www.ecfr.gov/current/title-49/section-173.185" }, { "label": "49 CFR 171.7: UN Manual incorporated by reference", "url": "https://www.ecfr.gov/current/title-49/section-171.7" } ] }, { "id": "gl-iec62133", "market": "global", "name": "IEC 62133-2: lithium cell and battery safety", "short": "IEC 62133-2", "what": "The international safety standard for portable sealed lithium cells and batteries (IEC 62133-2:2017+AMD1:2021). Product safety standards such as IEC 62368-1 expect compliant cells, and importers and retailers often ask for the report.", "because": "Your product contains a Li-ion battery.", "when": { "all": [ "p:li" ] }, "level": "likely", "steps": [ "test" ], "cost": null, "lead": null, "sources": [ { "label": "IEC 62133-2:2017+AMD1:2021 (IEC webstore)", "url": "https://webstore.iec.ch/publication/70017" } ] }, { "id": "gl-bt-sig", "market": "global", "name": "Bluetooth SIG qualification and listing", "short": "Bluetooth SIG", "what": "Every product that includes Bluetooth technology must be qualified and listed with the Bluetooth SIG. That's a licence requirement, not a government one, and it's separate from FCC or CE radio approval. It's also what lets you use the Bluetooth name and logo.", "because": "Your product uses Bluetooth.", "when": { "all": [ "r:ble" ] }, "level": "required", "steps": [ "file" ], "cost": { "text": "Qualification fee from Mar 1, 2026: $12,000 per product for Adopters (free membership); $8,000 for a Contributing Adopter's first qualification each year; $6,000 per qualification for Associates. The last two tiers pay annual dues.", "source": { "label": "Bluetooth SIG: qualification fees", "url": "https://www.bluetooth.com/develop-with-bluetooth/qualification-listing/qualification-listing-fees/" } }, "lead": null, "tip": "Building on an already-qualified module usually means referencing its qualification rather than re-testing, but the fee still applies to your product.", "sources": [ { "label": "Bluetooth SIG: qualification and listing", "url": "https://www.bluetooth.com/develop-with-bluetooth/qualification-listing/" }, { "label": "Bluetooth SIG: qualification fees", "url": "https://www.bluetooth.com/develop-with-bluetooth/qualification-listing/qualification-listing-fees/" } ] }, { "id": "gl-wifi-alliance", "market": "global", "name": "Wi-Fi Alliance certification (for the logo)", "short": "Wi-Fi CERTIFIED", "what": "Interoperability certification from the Wi-Fi Alliance. Only members can certify, and certification is what lets you use the Wi-Fi CERTIFIED logo. No government requires it.", "because": "Your product uses Wi-Fi.", "when": { "all": [ "r:wifi" ] }, "level": "maybe", "steps": [ "file" ], "cost": null, "lead": null, "sources": [ { "label": "Wi-Fi Alliance: certification", "url": "https://www.wi-fi.org/certification" } ] }, { "id": "gl-csa", "market": "global", "name": "Zigbee / Matter (CSA) and Thread Group certification", "short": "CSA / Thread", "what": "Certification from the Connectivity Standards Alliance (Zigbee, Matter) or the Thread Group proves interoperability and lets you use their logos. It's members-only, and no government requires it.", "because": "Your product uses Zigbee or Thread.", "when": { "all": [ "r:zigbee" ] }, "level": "maybe", "steps": [ "file" ], "cost": null, "lead": null, "sources": [ { "label": "CSA: why certify", "url": "https://csa-iot.org/certification/why-certify/" }, { "label": "Thread Group", "url": "https://www.threadgroup.org/thread-group" } ] }, { "id": "gl-lora", "market": "global", "name": "LoRaWAN certification (LoRa Alliance)", "short": "LoRaWAN cert", "what": "Optional interoperability certification for LoRaWAN devices. It's members-only, and certificates last five years.", "because": "Your product uses LoRa.", "when": { "all": [ "r:lora" ] }, "level": "maybe", "steps": [ "test", "file" ], "cost": { "text": "Certification fee for an end device: $1,200 via an authorized test lab or $1,700 self-tested (modules $2,000 / $2,800). Lab fees are extra.", "source": { "label": "LoRa Alliance: certification", "url": "https://lora-alliance.org/lorawan-certification/" } }, "lead": null, "sources": [ { "label": "LoRa Alliance: LoRaWAN certification", "url": "https://lora-alliance.org/lorawan-certification/" } ] }, { "id": "gl-ip", "market": "global", "name": "IP rating test (IEC 60529)", "short": "IP rating", "what": "IEC 60529 defines IP codes, such as IP67, for protection against dust and water. No market requires an IP rating by law, but if you claim one on the box or in marketing, you need a test to back it up.", "because": "You marked outdoor or wet use.", "when": { "all": [ "f:wet" ] }, "level": "likely", "steps": [ "design", "test" ], "cost": null, "lead": null, "tip": "Seals, vents and connectors decide the rating. Choose the target IP code before EVT, because adding sealing after tooling is expensive.", "sources": [ { "label": "IEC 60529 (IEC webstore)", "url": "https://webstore.iec.ch/publication/2452" } ] }, { "id": "gl-iec62471", "market": "global", "name": "Photobiological safety of LEDs and lamps (IEC 62471)", "short": "IEC 62471", "what": "Assesses eye and skin hazards from LEDs and lamps, including IR emitters, and assigns a risk group from Exempt to 3. It's how you show an LED-based IR or high-brightness product is safe where laser standards don't apply.", "because": "You marked a laser or IR emitter; this applies if it's an LED rather than a laser.", "when": { "all": [ "f:laser" ] }, "level": "maybe", "steps": [ "test" ], "cost": null, "lead": null, "sources": [ { "label": "IEC 62471:2006 (IEC webstore)", "url": "https://webstore.iec.ch/publication/7076" } ] }, { "id": "gl-cb", "market": "global", "name": "IECEE CB Scheme (one safety report, many countries)", "short": "CB Scheme", "what": "A CB test report and certificate from one participating lab can be accepted by certification bodies in other member countries, so you don't repeat safety testing for every market.", "because": "You're selling in several markets, and a safety standard applies to your product.", "when": { "all": [ "multi" ], "any": [ "p:ac", "p:li" ] }, "level": "maybe", "steps": [ "test" ], "cost": null, "lead": null, "sources": [ { "label": "IECEE (CB Scheme)", "url": "https://www.iecee.org/" } ] }, { "id": "gl-medical", "market": "global", "name": "Medical device regulators outside the US and EU", "short": "Device regulators", "what": "Health and medical claims bring in each market's own device regulator: Health Canada (Medical Devices Regulations), the MHRA in the UK, the TGA in Australia and Medsafe in New Zealand, and the PMDA and MHLW in Japan. Each has its own classes and registration route.", "because": "You marked medical or health claims.", "when": { "all": [ "f:medical" ], "any": [ "m:ca", "m:uk", "m:au", "m:jp" ] }, "level": "required", "steps": [ "design", "file" ], "cost": null, "lead": null, "sources": [ { "label": "Canada: Medical Devices Regulations SOR/98-282", "url": "https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html" }, { "label": "UK: regulating medical devices (GOV.UK)", "url": "https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk" }, { "label": "Australia: Therapeutic Goods (Medical Devices) Regulations 2002", "url": "https://www.legislation.gov.au/F2002B00237/latest/text" }, { "label": "New Zealand: Medsafe medical devices", "url": "https://www.medsafe.govt.nz/devices/devices-landing.asp" }, { "label": "Japan: PMDA reviews", "url": "https://www.pmda.go.jp/english/review-services/reviews/0001.html" } ] } ] }