Pmarszal
Involved In Discussions
Hello,
We are currently printing our own product labels which include the UDI barcode. Our product is identified by a serial number and expiration date that is included in the UDI barcode and also includes the device identifier.
We are looking for a third party to print labels for us. If we are assigning the DI and PI and verifying it in-house 100%, does the third party company need to be registered as a labeler in GUDID?
I am confused if the labeler need to be registered with GUDID just because they print the label, or enter the information into the GUDID system.
Thanks in advance.
We are currently printing our own product labels which include the UDI barcode. Our product is identified by a serial number and expiration date that is included in the UDI barcode and also includes the device identifier.
We are looking for a third party to print labels for us. If we are assigning the DI and PI and verifying it in-house 100%, does the third party company need to be registered as a labeler in GUDID?
I am confused if the labeler need to be registered with GUDID just because they print the label, or enter the information into the GUDID system.
Thanks in advance.
