You would like to run a new business that wants to import and distribute medical devices in Canada. This device will be intended as Dilator Sheath for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.
In maximum five pages, please describe the steps you would take to ensure that your establishment/business is in compliance with all Federal laws and regulations.
In addition, please outline how you would verify that the devices that you are importing from overseas would meet the Food and Drugs Act (FDA) and its regulations.
You would like to run a new business that wants to import and distribute medical
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