Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi community,

Our organization sells class II (FDA) and class IIa (MDR) devices.  Our contract manufacturer, ships our devices, in finished form and when we receive them there are 3 levels of packaging (primary, secondary and tertiary).  If a customer has requested that we repackage into smaller quantities, taking the product + primary packaging, and repackage into a smaller package, what "repackaging" requirements/guidelines must be followed?  The repackaging will be conducted with us and not the contract manufacturer.  
- UDI?
- Additional labeling for the new package?
- Packaging re-validation?

Hello Anon,

Yes, it could be all of that.  It is hard to provide a succinct response as there are many factors involved when re-packaging and re-labelling.  You should also consider needing a work instruction(s) for how this is completed including quality control and inspection.  There is not a specific guidance or regulation on this, the closest you will find in the US is the definition of a re-packager and re-labeller.  There is also some information in the UDI guidance that might be helpful.  There can be quite a few considerations though depends on device type, packaging, sterility status, etc.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Dec-2021 12:37
From: Anonymous Member
Subject: Repackaging Medcial Devices

This message was posted by a user wishing to remain anonymous

Hi community,

Our organization sells class II (FDA) and class IIa (MDR) devices.  Our contract manufacturer, ships our devices, in finished form and when we receive them there are 3 levels of packaging (primary, secondary and tertiary).  If a customer has requested that we repackage into smaller quantities, taking the product + primary packaging, and repackage into a smaller package, what "repackaging" requirements/guidelines must be followed?  The repackaging will be conducted with us and not the contract manufacturer.
- UDI?
- Additional labeling for the new package?
- Packaging re-validation?

Dear Anon,
Yes, yes and yes!
New UDIs are needed since the repackaged quantity is different.
The new packages will need labeling that reflects the new UDI and net content.
Since the packages have a different shipping weight and dimensions, a revised packaging validation would be appropriate.
Also, ensure that the site has repackager/relabeller listing with the FDA.
Best,

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Stacey Henning
Principal Specialist, Regulatory Affairs
Waukegan, IL United States
------------------------------

Original Message:
Sent: 10-Dec-2021 12:37
From: Anonymous Member
Subject: Repackaging Medcial Devices

This message was posted by a user wishing to remain anonymous

Hi community,

Our organization sells class II (FDA) and class IIa (MDR) devices.  Our contract manufacturer, ships our devices, in finished form and when we receive them there are 3 levels of packaging (primary, secondary and tertiary).  If a customer has requested that we repackage into smaller quantities, taking the product + primary packaging, and repackage into a smaller package, what "repackaging" requirements/guidelines must be followed?  The repackaging will be conducted with us and not the contract manufacturer.
- UDI?
- Additional labeling for the new package?
- Packaging re-validation?