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Contract Packager or Repackager? And can client assume responsibility?
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Contract Packager or Repackager? And can client assume responsibility?
Contract Packager or Repackager? And can client assume responsibility?
Contract Packager or Repackager? And can client assume responsibility?
Contract Packager or Repackager? And can client assume responsibility?
Contract Packager or Repackager? And can client assume responsibility?
Contract Packager or Repackager? And can client assume responsibility?
Contract Packager or Repackager? And can client assume responsibility?
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Contract Packager or Repackager? And can client assume responsibility?


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class ii medical device, contract services, non-sterile medical devices, single use devices (sud)
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Old 14th February 2018, 07:23 PM
suffusive

 
 
Total Posts: 2
Question Contract Packager or Repackager? And can client assume responsibility?

I have a situation with a very small client who is an initial importer of a Class II non-sterile, individually-wrapped, single-use device.

They get this device supplied in retail boxes (over-the-counter) from the Contract Manufacturer which may include 20 single-use, individually-wrapped devices.

But there are some size variations to this device so they also take receipt of individually-wrapped single-use devices and mix different sizes in a box themselves for the convenience of end users which they then directly ship to homes via a subscription service.

The problem is that the client is currently outsourcing this activity to a non-profit and they'd love to keep this activity there. In any other industry this activity would amount to simple order fulfillment/the most basic packaging job ever, but unfortunately it seems like the facility performing this outsourced operation needs to be FDA registered as a Repackager with appropriate QMS/controls in place. This is never going to happen at a little non-profit shop and therefore they will have to move this business elsewhere.

Any advice on how to navigate this would be great. The only approach I could think of is this:
This particular device can be sold in individual form in vending machines so this "bulk" individually-packaged form is DEFINITELY finished device form. That said, the non-profit shop isn't really "Repackaging" since they are taking completely finished devices and putting them in the exact same packaging/labeling that the retail versions have, just with a different mixture of sizes. Inasmuch as this is true, could we argue that the non-profit shop is functioning as a Contract Packager or Distributor and not a true Repackager?

I was also trying to think of ways my client could control the process/assume regulatory responsibility for this off-site activity, if you have ideas or unique approaches along those lines please let me know!

Thanks,
~Josh

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