Anon,
See the couple other recent posts - accessories can be treated as their own entity and may follow typical labelling requirements for the individual country.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 10-May-2024 11:29
From: Anonymous Member
Subject: Accessory Order Packaging box label
This message was posted by a user wishing to remain anonymous
What are the requirements of labelling for accessory order for class I (non sterile, non measuring, but reusable) medical devices for UK, EU, AUS, US, and NZ?
Currently, when we send through main device, we provide to distributor in a box.
And when we send separately means when distributor or end user asked, we shipped in a separate box and do mention PO # only in a shipping box for track only.
We don't add SN# on it.
Are we compliance with US, EU, UK, AUS regulations?
Will appreciate your expert feedback