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The definition of a Medical Device differs a little between countries. Very often whether something is a medical device or not will depend upon the intended use and claims made about it - what you write is as important as the device!
Many systems (for example: the U.S., E.U. and Chinese systems) are based on classifation of the device according to the envisaged risk associated with its use. The strigency of regulatory control in both the pre- and post- marketing environment will depend on this classification - the greater the risk, the greater the regulatory control!