You can manufacturer anything but you will not be able to commercialize it without getting approval (e.g. FDA approval in the US or CE marking in Europe) Anyth

You can manufacturer anything but you will not be able to commercialize it without getting approval (e.g. FDA approval in the US or CE marking in Europe) Anything that qualifies as a 'medical device' has a plethora of processes and documentation that must be delivered to the regulatory bodies for that specific country or region.