• Certifications: What you need to know


By Robin Schaffer | 16th March, 2016

The product development process can be a rather daunting task, but with the correct team and support, you will be able to ensure a successful market launch and grow your business exponentially. For a guideline on how to develop your new products, have a look at our previous post: 10-step new product development process. Still, there is one aspect of product development can easily be overlooked – certifications.


Product certifications are basically stamps of approval that your product has passed quality assurance and meets performance tests while adhering to certain regulations and specifications.

Certification is often done in tandem with the product development process, but if manufacturers or contract manufacturers claim to offer certifications themselves, make sure that they have experience with them as the process is rarely simple or easy. The product will usually need to go through two rounds of testing as well as surveillance in the marketplace to ensure it meets qualifications. Based on the certification, you may be shelling out thousands of dollars at the end of the process, so it is important for product developers to have at least a rough understanding of certifications and make room for them in their budgets from the beginning.


For new entrepreneurs, it can be tricky to identify which certifications to apply for and which ones are less crucial to your business. There are many learning resources available that can give you an in depth perspective, but for now, let’s go over the basics.


Here are 5 certifications that every product developer needs to know.

1. UL – Electrical Devices

The UL certification is the most recognizable of the Nationally Recognized Testing Laboratories (NRTL) in the United States which provides safety certifications, technical information and standards on products regulated by electrical code.

Why Get it?

If you want to target the US market, and your product is an electronically operated device, then an NRTL certification is a must. It is not legally required by Federal law, so UL approval is optional but may be required by some local inspectors.

Even so, if your widget does not meet a certification body’s requirements, it would be very difficult to enter the market. Most large companies will not buy equipment that is not certified, especially as it may be a liability if anything should go wrong.

The Certification Process

If after careful research you decide to certify your product with UL, you can submit your product for testing via an application form on their official website. It may take several months before your product meets the certification requirements. The most common UL label is the UL listing mark which can be found on computer equipment, appliances, fuses, electrical panel boards, heaters, smoke detectors to name a few.

Alternatives exist which meet the requirements of product safety standards in the United States. The differences lie the capabilities of the testing labs which issue the certifications as well as their prices and customer service quality. A list of approved certifications can be found on the website for the Occupational Safety and Health Administration (OSHA) under which the NTRL is a designation.

2. CE – European Equivalent of UL

The CE is a mandatory mark which certifies that industrial products have met health, safety and environmental requirements, allowing them to circulate freely within the European Union. This marking may also be found on products sold outside the EU that were manufactured in or designed to be sold the European Economic Area.

Why Get It?

If you plan to target the EU, the CE mark is necessary for product. It is required for 20 categories which include low voltage electrical equipment, medical devices, machinery, hot water boilers, construction products, and toys for children under the age of 14.

For a full list see the official website at: ce-marking.org

The Certification Process

The CE mark differs from the UL in market and in certification process. Most products can be self-certified by manufacturers using the EU standards to meet the requirements of the CE mark directives. Offshore manufacturers can do this as well, as long as the requirements are met. The manufacturer must then prepare a ‘declaration of conformity’ which is a document which shows that the product meets the necessary requirements. Once the product meets the CE mark, it can be sold throughout the European Union. The cost of this certification may be around $3000 to $5000 and can take 3 – 6 weeks.

3. FCC – Electronic Products

The FCC label is a mark of certification that electromagnetic interference from electronic products either manufactured or sold in the United states are under the limits set by the Federal Communications Commission.

Why Get It?

All electronic devices sold or manufactured in the US require at least the minimum FCC certification, even those which do not use radio transmitters since any device which contains a high speed clock may possibly interfere with other devices.

The Certification Process

If your device is an unintentional radiator, you would need an FCC verification or declaration of conformity. This is limited to devices such as cameras or clocks which do not emit radio waves as their primary purpose. To verify these, you could expect to pay a couple thousand dollars and wait 6 to 8 weeks. For a certification of intentional radiators, however, you could be paying anywhere from $10,000 to $20,000. Intentional Radiators include radios, wireless routers and Bluetooth modules, which emit radio waves as their primary purpose. The certification process may take anywhere from 8 to 12 weeks.

So if you want your product to be Bluetooth enabled, remember to set aside at least US$ 10,000 in your budget.

4. ISO – Waterproof / Water Resistant Products

ISO develops international standards but does not issue certifications. Standards provide guidelines, characteristics, requirements, or specifications that can be used to ensure that materials and products are fit for their purpose.

The most well-known ISO standards may be for waterproof and water resistant watches, but standards also exist for waterproof or high tension materials used in road vehicles.

Why Get It?

ISO certifications are performed by external certification bodies, and these certifications are signals to consumers, giving an idea of what the product can and cannot withstand. A watch that has been ISO 6425 certified, means that it meets the ISO standard as a divers’ watch and consumers can be sure that it can cover more extreme depths. Companies are not required to test their products according to this standard, but international standards give the products credibility.

The Certification Process

When choosing a certification body, it may be best to choose an accredited body as this confirms reliability. Prices and times vary depending on chosen certification body. The certification process is done in accordance with the chosen ISO standard.

5. FDA – Pharma/Medical Products

The Food and Drug Association (FDA) is a federal agency of the United States which supervises and regulates devices, drugs, and food additives for people and animals, color additives in drugs, food and cosmetics.

In the case medical devices, the FDA’s Center for Devices and Radiological Health (CDRH) regulates firms who manufacture, import, relabel or repackage medical devices sold in the US. It also regulates radiation emitting electronic products, even those that are not used for medical purposes such as color TVs and microwave ovens.

For all the categories listed above FDA must decide that the benefits of an item outweigh the potential risks – when the item is used as intended – before it can be approved. Once a product has FDA approval then it can be marketed for sale in the United States.

Why Get It?

Before a product that meets one of the aforementioned categories can be sold in the United States it must have FDA approval. This is a mandatory step as it is illegal to market these products without FDA approval.

Still, FDA approval is an expensive, rigorous, and time consuming process that may take years to complete.

In the case of cosmetics, checking the FDA manufacturing guidelines can prevent this process since cosmetics themselves do not have to be regulated.

The Certification Process

The FDA does not offer testing. This must be undertaken by the manufacturer with results being reviewed by the regulation body.
The most difficult product to approve is a new drug. It may take decades and hundreds of millions of dollars before it can be sold. The worst part? The odds of the drug being approved are about 1 in 1000.

The approval for food additives is less complicated. A petition which establishes that the additive is safe under its intended use must be filed with the FDA. Once this is demonstrated, the FDA can issue a regulation which specifies the terms of use for that additive.

As for color additives, cosmetic companies only have to conform to the existing FDA regulations and label their products properly. If not, the products may be detained and the companies will receive warning letters.

Finally, approval for medical devices greatly depends on how it is categorized. They are separated into Class I, II and III. The regulatory control increases with each class. Most Class II devices, such as a powered wheelchair, require pre-market notification, and Class III devices, such as an implantable pacemaker, usually require premarket approval. Class I, however, usually only needs to meet existing regulations.

More information on FDA regulations can be found on their website http://www.fda.gov

Conclusion:
Certification is an arduous but necessary process that is dependent on what kind of product you are making and where you want to sell it. If you want more than one certification for your product, then testing for them at the same time can dramatically cut costs. Another way to cut costs is to do your own preliminary testing before beginning the certification process. At the end of the day, product developers must conduct the necessary research and – if necessary – make room in their budgets before manufacturing their products.

Do you have an idea for an awesome new product? Contact us for a no-obligation project review

https://www.osha.gov/dts/otpca/nrtl/nrtlmrk.html
http://www.ce-marking.org/what-product.html
http://www.batteryspace.com/ul-ce-emc-fcc-and-csa.aspx
http://www.ul.com/global/documents/corporate/aboutul/publications/newsletters/electricalconnections/october08.pdf
http://ul.com/marks/ul-listing-and-classification-marks/promotion-and-advertising-guidelines/specific-guidelines-and-rules/
https://ul.com/code-authorities/electrical-code/
https://www.sparkfun.com/tutorials/398
http://www.iso.org/iso/home/standards/certification.htm
http://acstestlab.com/solutions/testing/wireless-testing
http://electronics.stackexchange.com/questions/5196/which-products-should-have-fcc-certification-and-about-how-much-does-that-cost
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194468.htm
http://www.fda.gov/Cosmetics/default.htm
http://www.rotlaw.com/legal-library/what-does-fda-approval-mean/
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm

Discover more great inspiration from Sourcing Overseas

About Us

Sourcing Overseas is an all-in-one offshore manufacturing consulting and product development firm whose mission is to bring your product from ideation to launch in a seamless manner, freeing you to build a successful business. Through years of experience, we are well-equipped to offer you a sophisticated and proven service that have helped hundreds of other clients to facilitate successful product launches. Just think of us as an extension of your company, your very own expert engineering and project management team.

Copyright 2016 Sourcing Overseas Co. Ltd All rights reserved (USA)1 800 724 9594 (Taiwan) 886 2 28365589