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Regulatory requirements for secondary packages in terms of label content

#1
Dear members
I am looking for specific regulatory requirements for secondary packages in terms of label content.
it is clear what should go on the device itself in terms on label content, yet what is the rule on any other layer of packages (except UDI which is clearly defined)? Should any level of packaging (say a carton box containing 10 devices) reflect the devics inside to the level of serial number?

Can you help providing references for US, Canada and EU?

Thank you all
 
#3
Hi Guy,
With most medical devices the labelling regulation do not go beyond the primary packaging. Requirements for secondary packaging are rare and are product specific. For example, the FDA has specific requirements for container and package (carton) label when it comes to Biological Products.

When there is no regulatory requirements from your secondary packaging, you should consider QA needs (e.g. storage conditions), distributor needs and customs needs. Most manufacturers just put everything on every label, but this approach of "overkill" is inefficient.

Cheers,
Shimon

P.S. Say 'hi' to Judith from me :)
 
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