We are a Medical Device manufacturer located in the Midwest and selling through distributors throughout the country. I received an email today from one of our distributors in Maryland stating that we need to obtain a license from the state of Maryland in order to sell our devices in that state.
The email states-
Our Maryland location received the following item from you: [part]. This item carries the following statements:
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician or Rx Only Symbol.
Thus making these items a prescription device; Maryland law states that any vendors shipping prescription devices into the state of Maryland are required to have a Maryland license to do so. As a Maryland -licensed drug and devices distributor, [Distributor] is required to verify the licenses of all of our vendors who ship prescription devices to our Maryland facility.
We received the above listed product(s) from your facilities . I need you to send me a copy of this facility?s license issued by the state of Maryland. If you do not have one please advise as to what action your company is going to take in order to be compliant with the state of Maryland?s regulations.
This is a medical device, not a drug. My understanding was that the distributor needs the license, not us.
Has anyone else run into this?
The email states-
Our Maryland location received the following item from you: [part]. This item carries the following statements:
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician or Rx Only Symbol.
Thus making these items a prescription device; Maryland law states that any vendors shipping prescription devices into the state of Maryland are required to have a Maryland license to do so. As a Maryland -licensed drug and devices distributor, [Distributor] is required to verify the licenses of all of our vendors who ship prescription devices to our Maryland facility.
We received the above listed product(s) from your facilities . I need you to send me a copy of this facility?s license issued by the state of Maryland. If you do not have one please advise as to what action your company is going to take in order to be compliant with the state of Maryland?s regulations.
This is a medical device, not a drug. My understanding was that the distributor needs the license, not us.
Has anyone else run into this?