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Tag Archives: Medical Device

No CE mark? No problem.

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading

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NZ Regs Shake-up – what will become of medical devices?

The New Zealand Ministry of Health has announced that they are developing a new regime for the regulation of therapeutic products. Following the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA), the New Zealand Ministry of Health is … Continue reading

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In a world of rapidly evolving technology, can we maintain regulatory clarity?

This was the question asked at a recent roundtable discussion hosted by BioMelbourne Network. Invited by the TGA, industry representatives were brought together to assess the new Software as a Medical Device (SaMD) guidance on the application of appropriate quality … Continue reading

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Industry Insight – TGA Blueprint

Regardless of the type of therapeutic good you commercialise – original brand medicine, generic medicine, biological or medical device – we all share the common challenge of operating in a heavily regulated market. Therefore the role of the TGA in approving these products for market entry and maintaining marketability is paramount for commercial success in the pharmaceutical and medical device industry. In this Industry Insight we see how the TGA’s Blueprint reforms stack up and look at the impact on industry. Continue reading

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Industry Insight – Ready for Joint Implant Reclassification?

Industry Insight is a new regular feature of Eye Spy. This month we address the latest challenge for sponsors of medical devices. Continue reading

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IVDs and Regulation

We assess the TGA’s new regulations for in vitro diagnostic products. Continue reading

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