The medical device industry is growing, and we’re seeing the impact at Two Labs as more and more clients are asking us for support in launching their new medical device products.
The medical device industry is projected to grow 6.8% through 2025.
One area of planning that these clients are seeking advice on is state licensing. While the state licensing process for a typical new drug launch may be complex, states are generally good at putting their requirements out there for us to work with.
But for medical devices, it’s a different story. Licensing boards tend to be more vague about their states’ requirements for medical devices, if they have any at all. Most states don’t even mention medical devices in their statutes or regulations, leaving manufacturers to dig for this information, or else risk launch delays down the road.
Two Labs’ experience and relationships with state regulators allow us to keep up with what isn’t in the fine print.
To date, at least 20 states currently do require device manufacturers to carry a license to distribute in their state. And although this information is hard to track down, it’s still the manufacturers’ responsibility to check those boxes.
Here are just a few examples. California requires a license, but only if it’s your home state. New York, New Jersey and Pennsylvania all require licenses, but the specifics vary for each one. And similar to typical drug licensing, these nuances depend on the relationships between the client, their CMO, and their 3PL. Or if a state is an FDA-approval state, that could also warp the process.
How do you know if you need a license to distribute across certain state lines? The short answer is: it depends. But you don’t need to spend time researching each state’s requirements and cross-referencing with your device launch plan. We’re here to help you navigate the nuances of each state you’re looking to distribute in.