Certifications got you feeling certifiable?
A topic that everyone seems to have an opinion on with all of the changes in FDA regulations this year …
Disclaimer: We are not experts. We do not work for the government or the FDA. This blog is intended to simply share our experiences and provide useful tips for businesses in similar positions.
Spectrum has been in business for 30 years and we’ve been an FDA importer for about 20 of those years. What this means is we had to register with the FDA to bring in any product that is deemed a medical product by the FDA. This ranges from exercise equipment, to masks, to stethoscopes, and certain types of drugs.
Businesses cannot bring any products into the U.S. unless they are a registered FDA importer. This changed in 2020 due to regulations because of Covid-19 so that suppliers could import PPE quickly. Companies that were not FDA registered were allowed to bring in products as long as they met basic FDA requirements. Everyone started bringing in these products, and there were a lot of counterfeit and unregulated goods, which put pressure on customs and the FDA to make sure they are really looking through these goods. This has also put pressure on the regulating organizations of exporting countries to make sure they are doing their due diligence as well.
There is a lot to consider when working with new customers and medical suppliers. Here are some things we feel you should do as a precaution to make sure you are following regulations and staying in a generally safe zone for doing business:
If you’re looking at a long-term partnership with a vendor, their FDA importer number is important. You should know that your vendor is FDA registered and can still bring in the products as regulations change down the line.
Another thing to watch for is if your client asks for an FDA registration number or anything like that. The first thing to do is to provide the vendor’s FDA number and that should suffice in order to say that they are an FDA importer and they only bring in FDA certified products.
The second thing to do is look for the FDA number and registration number on each specific product. A lot of vendors will ask you to sign a non-disclosure agreement in order to protect themselves because this information is going to the distributor and the client.
You can double check that the FDA number is legitimate by checking it in the FDA database.
We hope you are able to find these tips useful as you become a reliable partner for your clients in the medical industry. We wanted to share this with you because the medical industry is growing and will continue to grow for many years … but that’s a topic of its own which we hope to share on our blog in the near future …