top of page

The photo to the left is misleading...the FDA regulations could fill a stadium.  Thank God our products (Class I Medical Devices) are subject to far less regulation than most other medical devices.  Here is how it works:  In order to import, or manufacture class I medical devices (like eyewear) you must register your establishment (your business) with the FDA and pay an annual fee. (2018 fee is $4631.00)  You are, however, allowed to distribute class I medical devices without being an FDA registered establishment.  So if you were registered in the past with the FDA you simply suspend your "Initial Importer" status and become a "domestic distributor", which frankly is a better description of what you do to earn your profits anyway.  Through a legal agreement with my company we agree to import your products for you.  The shipments still go directly to you and you still maintain all of your relationships with your foreign suppliers and all of your accounts with them and your shipping companies.  We still have to register all of your suppliers and your brand names with  the FDA on our FDA profile page, but we don't get involved directly with any of them.  Just like now, your foreign manufacturers and your foreign exporters must also register and pay their FDA establishment fee in order for us to do business with them.    

Who must Register and Pay?
bottom of page