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In The News

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TGA releases new clinical guidelines for Medical Devices and IVDs 31 Mar 2017

The Australian TGA has published more detailed guidance on clinical evidence requirements for medical devices and IVD products.

TGA clinical evidence requirements are based on GHTF standards and European MEDDEV documents.

Australian regulators may demand clinical evidence from medical device and IVD registrants at any time, not just during premarket review.

Full Emergo article - click here

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