Hello Mauro,
Indeed the shipping box/shipping box label information is not regulated by the medical device (if speaking about medical devices) requirements. In fact, in some cases like UDI is explicitly states this is not required at the shipping level. However, the requirements related to information on the shipping box are related to import and export requirements where product is being sent from and going into which country. You need to check what are the import/export requirements for information placed at the shipping level. In many cases, it can just be the sender and consignee. Though depending on the shipment, there may be many other paperwork which contains information about the identity, quantity, and special conditions of the goods in the shipment. The outside shipping box may also need designations or warnings if containing certain materials inside the shipping box, i.e. batteries, liquids, chemicals, biohazardous.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Oct-2022 13:32
From: Mauro Rinaldi
Subject: Mandatory information on Shipping Box EU /US
Dear Regulatory experts,
could somebody help with the mandatory information to be placed on the shipping box label for the EU /US.
From the regulation, I understand that a shipping box doesn't follow device packaging labelling regulation.
What is mandated? what is sufficient to place on the delivery note?
Thank you
Mauro
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Mauro
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