Medical device package insert in EU and USA

med_cert

Involved In Discussions
Hello,

we are required to provide a document "Medical device package insert in EU and USA". This is official requirement by Japanese ministry.
Some guidance we received from our distributor is attached...

Does anyone has any clue hiow should it look like?
 

Attachments

  • Package-Insert-Notification-System-JAPAN.pdf
    1.4 MB · Views: 270

Watchcat

Trusted Information Resource
"Package insert" is the pharma term for "IFU." You should provide IFU(s) that support FDA clearance/approval and those that support CE Marking, if they are different. They should be in the format that you use when distributing them with your device in the US and EU.
 
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