10. Do I need to apply for an amendment to my Medical Device Establishment License if I am adding a product which adds a new Class to my license?

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  • 10. Do I need to apply for an amendment to my Medical Device Establishment License if I am adding a product which adds a new Class to my license?

In the case of a new Class of device being added to the listing of your Medical Device Establishment License, you will need to apply for a full amendment with associated fees (visit the SAMED website for the fee schedule).

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