If 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.
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.
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.
No salesperson will call you
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system t
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