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GHTF

Critical guidance documents adopted

The Global Harmonization Task Force (GHTF) steering committee has adopted as final five guidance documents, two of which are being promoted as being crucial to the group's efforts to achieve convergence in global medical device regulation.

The two documents, for use by regulatory authorities updating existing or developing new regulatory requirements for medical devices, are: SG1/N015:2006 Principles of Medical Device Classification and SG1/N040:2006 Principles of Conformity...

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