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Warning: Gridlock Ahead

Through 2013,  TGA required reclassification of implantable load bearing joint prostheses from Class IIb to Class III.  To encourage early submission, TGA offered a fee free window for applications submitted…

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RoHS 2 - Just Six Months To Go

The 2011 “Recast” (Eurospeak for “revision”) of the Restriction of Hazardous Substances Directive, dubbed RoHS 2, introduced a rolling phase-out of the exemptions built into the original RoHS 1. This…