Medical device Label

RachelM

Starting to get Involved
We have class lll medical devices that ship to US and Canada, can we have Identifiers for both (Canada licence number and device identifier and USA licence number and device identifier) on the same packaging label. So it is easy for us, and not have multiple labels in place?
 

GERAI LTD

Registered
We have class lll medical devices that ship to US and Canada, can we have Identifiers for both (Canada licence number and device identifier and USA licence number and device identifier) on the same packaging label. So it is easy for us, and not have multiple labels in place?
Do you have an Importer in Canada or are you using your own establishment?
 

GERAI LTD

Registered
We have class lll medical devices that ship to US and Canada, can we have Identifiers for both (Canada licence number and device identifier and USA licence number and device identifier) on the same packaging label. So it is easy for us, and not have multiple labels in place?
Yes, you can include both the Canada licence number and device identifier, as well as the U.S. licence number and Unique Device Identifier (UDI) on the same packaging label. This is permissible as long as the label complies with the regulatory requirements of both Health Canada and the U.S. FDA, ensuring that all necessary information is clearly displayed and meets each country's specific guidelines.
 

RachelM

Starting to get Involved
Yes, you can include both the Canada licence number and device identifier, as well as the U.S. licence number and Unique Device Identifier (UDI) on the same packaging label. This is permissible as long as the label complies with the regulatory requirements of both Health Canada and the U.S. FDA, ensuring that all necessary information is clearly displayed and meets each country's specific guidelines.
Great this helps. Thank you.
 
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