Designing a new consumer electronic product from scratch has led me to the broad and intimidating subject of regulatory requirements. If you want to import original products from China, or Vietnam, or India, or anywhere else, to the US, Europe, Australia, or other western markets, you are required by law to comply with numerous regulations and standards. Below is what I know so far:
- Consumer electronics must be tested to ensure compliance with CFR Title 47 Part 15, which is the FCC’s regulations around radio emitters. Whether your product is an intentional or unintentional radio wave emitter or receiver, you need testing performed by a 3rd party to ensure compliance. My device happens to be an intentional radiator since it uses both Bluetooth Low Energy (BLE) and WiFi. 3rd party testing companies must be accredited, and I’ve heard that Intertek, CMA, and SGS can perform the testing, although I have not used anyone yet, and have no affiliation with any of them. A Declaration of Conformity is then required by the supplier (you/me), including:
- Issuing company
- Product name
- Model number
- Applicable standard
- Representative name and signature
- Supporting test certification
- Underwriter Laboratories (UL) mark is not required by law, but may be required if you’re going to be a supplier to some larger enterprise. For me, I’ll consider if my suppliers are UL listed, but not go beyond that.
- California’s Proposition 65 requires testing OR the following statement included on product packaging. Clearly it’s easier and more cost-effective just to include the warning:
Prop. 65 Warning for California Residents
WARNING: This product may contain chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm.
- The Customs and Border Protection agency requires the Country of Origin be printed on the product and in packaging. Just do it. I’m going for “Made in Vietnam.”
- The Consumer Protection Safety Commission has rules around specification product categories. Make sure you products don’t fall under these, or meet the requirements if they do:
- Federal Hazardous Substances Act (FHSA) list of materials here: https://www.cpsc.gov/Regulations-Laws–Standards/Regulations-Mandatory-Standards-Bans
- General Certificate of Conformity (GCC) list of product categories here: https://www.cpsc.gov/Business–Manufacturing/Testing-Certification/Lab-Accreditation/Rules-Requiring-a-General-Certificate-of-Conformity/
- I will have a 3rd party test my product for compliance with Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The following companies have been recommended to me, although again I have not used anyone and have no affiliation: SGS, Bureau Veritas, QIMA, and TUV.
- The EU additionally has Restriction of Hazardous Substances Directive (RoHS), which applies specifically to electronic components. I’ll make sure my supplier use RoHS-compliant components, but don’t think I need to take any action beyond that.
- The Radio Equipment Directive (RED) is analogous to the FCC’s requirements in the US, and necessitates 3rd party testing (Bureau Veritas, Intertek, SGS, or TUV) and documentation including a Declaration of Conformity (DoC), user manual, and technical file. Meeting this any other applicable EU requirements then allows the CE mark to be placed on the device.
- The product packaging must all including labeling to comply with the Waste Electrical & Electronic Equipment (WEEE) directive.
There may be other regulations applicable to your product. What has been your experience in dealing with regulatory compliance for a new consumer product?