Regulations for Relabeling of Medical Device for Address Change



Does anyone know the impact or regulations for relabeling of product due to a new address change in US and OUS?



Re: Relabeling of medical device for address change

Are you the Manufacturer of the product? If so, you can re-label as required as long as you have appropriately controlled systems and all critical information is retained, i.e. the new label displays the same manufacturing date, expiration date, etc. as the old label.

Fully document what you're doing, of course, in case there are questions later.

In the case of labeling on validated packaging, you have to be sure that the validation conditions are conformed to. Sometimes it's not possible to re-label sterile packaging, for instance.

Often it's easier, and avoids both customer and regulator/auditor questions, to put a second small label alongside the original label--perhaps in distinct colors--with the new address/contact information and a brief explanation of what change occurred and when.

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