If you intend to market or manufacture your product overseas, then you will need to understand international product certifications. Product certifications essentially ensure that a product has passed various performance tests and quality assurance checks before it hits the mass market. In some cases, certification is legally required in specific countries; in others it can simply help avoid a nasty public relations industry. At first, this might seem like another frustrating barrier to success once you’ve finished your dream product, but, remember that these legislations are in place to keep us all safer, and for the good of the industry and the environment as a whole.
While there are a number of certifications required for different countries and different types of products, here are some of the main examples to consider when manufacturing or marketing abroad:
CE
CE is the ‘European Union EMC & Safety Compliance Declaration’. This certification is required for all products that have an input of 50-1,000 Vac or 75-1,500 Vdc, as well as for products that could be affected by an electromagnetic disturbance.
UL
UL is North American Product Safety Certification, a common North American certification from Underwriter Laboratories. This mark shows that a product was tested by UL, that it meets US and Canadian safety standards, and that the manufacturer’s facilities have undergone periodic checks to ensure that everything is in working order as well. This may not be a requirement, but if you hope to sell to businesses, then it can help a lot with sales.
ESUI
ESUI stands for ‘Essential Safety & Usage Information’. This international product certification shows that NI (National Instruments) products include essential information regarding proper usage and safety. In other words, they ensure that enough information is provided along with the actual product itself.
FCC
FCC is a certification from the U.S. Federal Communications Commission which relates to electromagnetic interference regulations regarding a range of transmitters, receivers, and IT. Anything that has a radio or connectivity will often need to go through a range of tests, this would include products such as a computer, a smartphone, or of course, a radio. All IoT wearable devices would need to obtain this certification before hitting the market.
WEEE
WEEE stands for ‘Waste Electrical and Electronic Equipment Directives’, so it’s not as fun as it sounds at first. This relatively new set of directives was passed by the European Union in 2003, and aims to improve the environmental performance of a number of electronic equipment by ensuring that they are manufactured in an eco-friendly manner. Member states adopted legislation in 2005, so it’s required if you’ll be selling in Europe.
RoHS
Also from the EU comes RoHS, which restricts the use of mercury, lead, cadmium, chromium, and a number of other substances for use in electronic equipment in the European market. Explore the precise levels involved here.
China RoHS
For those selling or manufacturing in China, the Control of Pollution Caused by Electronic Information Products requirements apply. Products marked with the ‘e’ logo are free from hazardous materials.
FDA
The FDA is the Food and Drugs Administration which you most often think of as regulating drugs companies and food companies (hence the name!). If your device is medical in nature though then it will still fall under FDA jurisdiction. Electronics regulated by the FDA include x-ray equipment, laser products, mercury vapor lamps and microwaves. Meanwhile, medical devices might mean dentures, surgical implants or prosthetics. This could even apply to some particularly advanced health trackers in that case. Learn more here. If your device is intended for use with animals meanwhile, you may need to check the Center for Veterinary Medicine.
According to David Lennarz, VP of Registrar Corp, U.S. FDA Compliance Assistance, “Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA).” See the rest of his answer here.
Conclusion
The best way to proceed if you are planning on selling anything electrical, or anything that will come into contact with the skin or with food, is to research the individual areas that you intend to sell your product in. You may also want to consult with your manufacturers or lawyers. You can find more information on various international product certifications from the National Instruments website.
The pricing and cost for each of these certifications will vary depending on the product you are developing. We suggest contacting companies that deal with product certifications and testing for further information. A few on our list are:
Are there any other certifications you believe that everyone should also be aware of? Do you have any tips on international product certifications to share with your fellow makers? Be sure to leave a comment below and let us know what you think! Sign up for our FREE newsletter here to know more about product certifications and tips on establishing your hardware startup.
