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From my understanding of this revised regulation both the Package Insert and Device Label now need to include both Date of Manufacture and Expiration Date as of October 01, 2014.
As we typically do not include manufacturing dates on IVD labels, has anyone else implemented this change? Anyone shipped product to China since Oct 01 without the DOM on the labelling?
Is anyone aware of any grace period for implementing this regulation. Our problem is we need to ship product that was manufactured before the date of this regulation, so do we now need to rework the finished to add the DOM before shipping?
Another one of the new regulations requires all labelling changes to be submitted to the CFDA for approval. So can this change to add the Date of Manufacture even be done without the prior labelling change approval from CFDA?
As we typically do not include manufacturing dates on IVD labels, has anyone else implemented this change? Anyone shipped product to China since Oct 01 without the DOM on the labelling?
Is anyone aware of any grace period for implementing this regulation. Our problem is we need to ship product that was manufactured before the date of this regulation, so do we now need to rework the finished to add the DOM before shipping?
Another one of the new regulations requires all labelling changes to be submitted to the CFDA for approval. So can this change to add the Date of Manufacture even be done without the prior labelling change approval from CFDA?
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