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FDA regulations for medical devices cover technical specifications, documentation, lab testing and labeling requirements.
For example, the mandatory labels include the following information:
Manufacturer / Importer
Unique device ID
c. Food & Beverage
The FDA regulates most types of food products and beverages, imported and sold in the US. Some types of food require a pre-market approval, before imported to the United States.
In addition, the FDA also regulates how food product packaging must be labelled:
The FDA also regulates health benefit claims, and other claims made on the food packaging.
Do I need to get my products tested by the FDA?
FDA generally don’t test products, but there are testing companies that do.
So do you need to get your FDA regulated products tested?
That depends. For some products, third party compliance testing is mandatory, but that is not the case for most categories regulated by the FDA.
Just keep in mind that the US customs, CPSC or FDA can request test reports, or other documents, that prove that your products are compliant – even if lab testing is not required by law.
If they have reason to believe that your imported food packaging or medical device is non-compliant, they have the power to force you to provide test reports and other documents – or issue a forced recall.
That is the last thing you want to happen.
To be on the safe side, always book a third party lab test, before importing FDA regulated products from China.
All of the large laboratory testing companies can help with ‘FDA testing’, including, but not limited to;
When contacting these labs, you should not refer to ‘FDA testing’. At a very minimum, you should provide product information, and explain that they should do all testing required for the certain product category, in the United States.
Or, even better, refer directly to the regulation, such as 21 CFR.
Do I need a premarket approval from the FDA?
Yes, when importing certain types of medical devices, or even food products, you need to obtain a premarket approval. Without such an approval, you cannot legally import and sell the product in the United States.
Keep in mind that only a US entity can obtain a premarket approval, so don’t rely on your supplier to do it for you.
The pre-marketing approval requirement is also applicable to certain substances used in food packaging and kitchen utensils.
The problem, when importing from Asia, is that most suppliers don’t have detailed documentation of the materials – that covers chemicals and heavy metals.
Hence, importers can only rely on third party lab testing to assess if a premarket notification is necessary or not.
Do I need to make sure that my products are FDA compliant to sell on Amazon.com?
Yes, like in all marketplaces, sellers on Amazon.com must comply with all applicable product regulations in the United States.
That said, FDA only regulates products sold in the United States. If you, for example, plan to sell products on Amazon.de or Amazon.co.uk – you must ensure compliance with European Union product regulations.
In addition, the EU has its own documentation, labeling and lab testing requirements. A premarket notification submitted to the FDA in the US, cannot be used to sell the same product in Europe.
Further, Amazon is increasingly strict when it comes to enforce product compliance. Many product categories, some of which are within the scope of FDA regulations, are restricted – and must be ‘unlocked’ by the seller.
Part of this process involves the submission of compliance documents.
They are also actively reviewing products and sellers, and can reject any product that is listed without the sufficient compliance documents.
While they currently reflect the legal minimums set in each country, it’s possible that Amazon will go beyond this – and set product standards that are even higher than what is required by the FDA.
How do I find ‘FDA certified’ suppliers in China?
First of all, a supplier cannot be FDA certified. It comes down to the product, not the company.
That said, a product can be ‘FDA compliant’.
As mentioned, the FDA is not a standard – but a federal government agency that administers regulations for many different product categories.
Yet, many Chinese suppliers refer to FDA as a standard. When browsing manufacturers of kitchen utensils on Alibaba.com or Globalsources.com, it’s common to see suppliers stating ‘FDA compliance’.
What they actually mean, is that their product is 21 CFR compliant.
In the end, what matters is that they can make a compliant product. This can, however, not be taken for granted when sourcing suppliers in China.
Many suppliers don’t have a clue if their products contain chemicals or heavy metals that are restricted by the FDA.
At best, they can provide a Chinese language substance list from a subcontractor, but that is far from enough.
Yet, it’s also about as good as it gets.
When sourcing suppliers, you should always limit your selection to those that can provide verifiable test reports and chemical documentation.
But, you cannot expect to find suppliers that have test reports for their entire product catalog. At best, you will get a two or three test reports, that may not even be valid in the US.
But that’s acceptable.
How do I know if my supplier can make an FDA compliant product?
The only way to be sure, is to send a pre-production sample for laboratory testing. As mentioned, there are plenty of compliance testing companies that can verify if your product is compliant with all relevant FDA regulations.
Just keep in mind that compliance testing can be costly. Labs charge at least US$500 for one product sample.
Co-founder of Asiaimportal (HK) Limited and based in Hong Kong. He has been quoted in and contributed to Bloomberg, SCMP, Alibaba Insights, Globalsources.com, China Chief Executive, Quartz Magazine and more.
Hey there, I’m Fredrik!
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