Regulatory Open Forum

I work for a medical device distributor in the US and our sister company (manufacturer) would potentially like us to repackage and relabel devices for them that get returned to our distribution center. Sometimes the marketing box would be damaged upon return and instead of returning the marketing box/device back to the manufacturer, and to save on shipping costs back to the manufacturer, they would send us marketing boxes/labels for us to repackage/relabel.

We would not change any content of the labeling supplied from the manufacturer and would only repackage in the marketing boxes they supply to us.

So, my question is – would we have to register/list as a repackager/relabeler?

Thank you for any help!

I work for a medical device distributor in the US and our sister company (manufacturer) would potentially like us to repackage and relabel devices for them that get returned to our distribution center. Sometimes the marketing box would be damaged upon return and instead of returning the marketing box/device back to the manufacturer, and to save on shipping costs back to the manufacturer, they would send us marketing boxes/labels for us to repackage/relabel.

We would not change any content of the labeling supplied from the manufacturer and would only repackage in the marketing boxes they supply to us.

So, my question is – would we have to register/list as a repackager/relabeler?

Thank you for any help!

I work for a medical device distributor in the US and our sister company (manufacturer) would potentially like us to repackage and relabel devices for them that get returned to our distribution center. Sometimes the marketing box would be damaged upon return and instead of returning the marketing box/device back to the manufacturer, and to save on shipping costs back to the manufacturer, they would send us marketing boxes/labels for us to repackage/relabel.

We would not change any content of the labeling supplied from the manufacturer and would only repackage in the marketing boxes they supply to us.

So, my question is – would we have to register/list as a repackager/relabeler?

Thank you for any help!

I work for a medical device distributor in the US and our sister company (manufacturer) would potentially like us to repackage and relabel devices for them that get returned to our distribution center. Sometimes the marketing box would be damaged upon return and instead of returning the marketing box/device back to the manufacturer, and to save on shipping costs back to the manufacturer, they would send us marketing boxes/labels for us to repackage/relabel.

We would not change any content of the labeling supplied from the manufacturer and would only repackage in the marketing boxes they supply to us.

So, my question is – would we have to register/list as a repackager/relabeler?

Thank you for any help!