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CONTACT USIf you are thinking about entering the US market for the first time, understanding the FDA regulatory requirements can be overwhelming. Information about medical device regulations on the US FDA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer.
Free information packet makes it easier to understand the process in the US
To help medical device manufacturers who want to export medical devices to the US, we assembled a packet that includes the basic information you need before deciding to enter the US market. It outlines the registration requirements and ongoing obligations to maintain compliance.
Here is what we will send you
If you set aside just one hour to read/watch these items, we guarantee you will have a MUCH better understanding of how the US FDA regulatory process works.
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