Before jumping in the deep, describing the most common types of product certification, let’s make sure you know what product certification means.
Product certification can be explained as the process of certifying that a specific product fulfils requirements set out in contracts, regulations or specifications (aka “certification schemes”) and has passed all necessary quality assurance and performance tests. Product certification is often required in industries and marketplaces where product failure could bring serious negative consequences to the health and safety of people, animals and property. Sometimes the consequences can be even fatal. Product certification gives product users the confidence they need to purchase certain goods. If a product is certified according to applicable national or international laws, customers know that that product will function correctly and won’t cause any harm.
Violations of product certification very often result in severe legal punishments such as monetary fines and product recalls, or even imprisonment.
Certified products are typically endorsed with a certification mark, aka conformity mark. The product certifier provides the product certification mark. It is usually affixed to the product itself, somewhere easy to see. It allows users to track down the type of certification to determine the criteria that a specific product meets. Some often-required types of product certification are CE marking, FDA, FCC and CB Scheme. You can read about each one of these types of product certification below.
CE marking – Europe
CE marking is a legal requirement allowing free trade of products within the EU/EEA. It represents a manufacturer’s declaration that a product complies with the minimum product safety, health, and environmental requirements of all relevant EU directives. The CE marking is a mandatory certification mark for non-food products placed on the market in the EU/EEA. It indicates that a product:
- Fulfils the requirements of all applicable EU product directives,
- Meets all the requirements of the relevant recognised EU harmonised standards,
- Is fit for its purpose,
- Will not endanger lives or property.
The presence of CE marking on a product further indicates that appropriate technical documentation supporting the use of the certification mark is available.
The FCC is a mandatory certification mark for electronic equipment and electronics that are manufactured or sold in the USA. This marking certifies that a specific product complies with standards of the Federal Communications Commission regarding electromagnetic interference. The FCC label is mandatory for products such as IT equipment and industrial or medical devices that emit RF radiation.
If a product is manufactured in the US but sold outside the US territory, it must have FCC certification. The opposite is true as well. If a product is made outside of the US but sold within the US, it must have the FCC marking affixed on it.
IECEE CB Scheme – Europe, North America, parts of Asia and Australia
The CB Scheme is an international program established and operated by the International Electrotechnical Commission for Electrical Equipment (IECEE). The CB Scheme is a global system for mutual acceptance of product safety test reports and certificates. It offers product manufacturers a simpler way of obtaining several national safety certifications for their products. The CB Scheme provides manufacturers and importers with a market entry into over 50 countries worldwide. It is beneficial for everyone: governments, industries and end-users.
FDA – the USA
FDA stands for the Food and Drug Administration in the US. It is a government agency responsible for the safety and efficacy of various types of products that are being sold or manufactured in the United States. For instance: medicines, food, medical devices, cosmetics, radiation-emitting electronics, veterinarian products and tobacco products.
The FDA certification and registration are mandatory for companies that manufacture, re-pack, re-label or sell any of the afore-mentioned product groups, except for cosmetics.
A product can be FDA approved or FDA cleared, and it’s imperative to understand the difference.
If a product is FDA approved, it means that the benefits of that product outweigh the known risks. To get an FDA approval for their products, manufacturers must submit a premarket approval application (PMA) and the clinical data results. Products such as medical devices class III require FDA approval.
FDA cleared means that the manufacturer can demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that has already received FDA clearance or approval. Medical devices class I and class II require FDA clearance.
Clever Compliance – One place for all product certification needs
Clever Compliance offers a compliance marketplace and a compliance management system. For you, who is looking for a way to obtain any of the above-described types of product certification marks, the compliance marketplace is where you need to be.
The catalogue of services covers a vast range of product types, and any compliance needs can be met. Many importers, manufacturers and suppliers visit it on a daily basis. It is the place where importers can get certificates for their products and manufacturers can book test centres, consult with experts or request any other compliance help they may need.
The access to the compliance marketplace is free of charge and just a click away. It has a user-friendly interface and is 24/7 accessible.
So, with all that said, go ahead and explore it!