For your situation, if your 3PL (distributor) does not have state distribution licenses for medical devices, in each required state, you will need one under your name. But that's the only state licenses besides FDA clearances if you are not manufacturing in the US, and if your devices are not specific electronic licenses, such as X-ray, CT, laser based devices.
Have a look at the HIDA (Health Industry Distributors Website). The major distributors have these licenses. If you don't want to go through a full distributor, I had run at estimating cost and time to get them. Plan on 12-18 month to get the state licenses, and a service to help you do it at a cost- total maybe 30k? The licenses range from 1 to 3 year duration, and are not inexpensive.
Again, you may find more information on the HIDA website.
Www.HIDA.com I believe.
------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 20-Jan-2023 17:27
From: Anonymous Member
Subject: State license for OTC DTC Class II medical device
This message was posted by a user wishing to remain anonymous
Dear RAPS members,
I have a question related to State Licensing. We are a Class II medical device manufacturer with headquarter outside of USA and currently applying for FDA authorization. We want to commercialize our product in all states in USA and will be using 3PL service to warehouse and ship our product. Do you think our over-the-counter (OTC) and direct-to-consumer (DTC) product will need state licensing in any of the states? If yes, which states? Also, do you know of any company that helps with the state licensing? Please suggest. Thanks in advance!