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Hello Cove members,
I have a hypothetical scenario and need your help to address it:
If a Medical device firm has an approved device in Canada but not in USA, can this device be imported into USA for Service purpose only i.e. to say if the device malfunctions at the end-user facility in Canada, will it be possible for the service/distributor firm in USA to legally bring the device into USA and repair the device and return to the end-user?
Is it possible for a firm to export an unapproved device (in USA) to another country (legally approved) and does it fall under section 801(e) (1) of the FD&C act?
Thanks
I have a hypothetical scenario and need your help to address it:
If a Medical device firm has an approved device in Canada but not in USA, can this device be imported into USA for Service purpose only i.e. to say if the device malfunctions at the end-user facility in Canada, will it be possible for the service/distributor firm in USA to legally bring the device into USA and repair the device and return to the end-user?
Is it possible for a firm to export an unapproved device (in USA) to another country (legally approved) and does it fall under section 801(e) (1) of the FD&C act?
Thanks