Guideline

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Information Document Concerning the Definition of the Term “Medical Device”
Internet:	http://www.ghtf.org/documents/sg1/sg1n29r162005.pdf
Origin/Publisher:	GHTF
Content:	This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.