SGquality

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#1
We had a very interesting discussion this morning where the team was split in use of both Lot Numbers and UDI serial numbers. We will be having a new Class II medical device where each of the units (these are small units and not huge capital equipment) will have a UDI serial number. These units are contract manufactured in China.

The question is if Lot Number is required or would UDI be alone acceptable to demonstrate traceability?
 

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