---
title: Medical Device Regulations Blog | Australia
description: Australia | All the news on Medical Device Regulations around the globe
---

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# Articles about Australia

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 Feb 22, 2023 8:15:00 AM

## [Accelerated pathways for innovative medical devices](https://www.regtik.com/mdrblog/accelerated-pathways-for-innovative-medical-devices)

Bringing medical devices to market is a process that often takes years. Manufacturers are required...

[![](https://www.regtik.com/hs-fs/hubfs/Public%20Health.%20Medical%20Concept%20with%20Blurred%20Text%2c%20Stethoscope%2c%20Pills%20and%20Syringe%20on%20Grey%20Background.%20Selective%20Focus..jpeg?width=365&name=Public%20Health.%20Medical%20Concept%20with%20Blurred%20Text%2c%20Stethoscope%2c%20Pills%20and%20Syringe%20on%20Grey%20Background.%20Selective%20Focus..jpeg)](https://www.regtik.com/mdrblog/mdcg-publishes-guidance-on-health-institution-exemption-under-eu-mdr-/-ivdr)

 Feb 20, 2023 7:15:00 AM

## [MDCG publishes guidance on health institution exemption](https://www.regtik.com/mdrblog/mdcg-publishes-guidance-on-health-institution-exemption-under-eu-mdr-/-ivdr)

The Medical Devices Coordination Group (MDCG) has published guidance discussing the health...

[![](https://www.regtik.com/hs-fs/hubfs/wesley-tingey-snNHKZ-mGfE-unsplash%202.jpg?width=365&name=wesley-tingey-snNHKZ-mGfE-unsplash%202.jpg)](https://www.regtik.com/mdrblog/medical-device-essential-requirements-understanding-the-basics)

 Jan 2, 2023 8:30:00 AM

## [Medical device essential requirements – understanding the basics](https://www.regtik.com/mdrblog/medical-device-essential-requirements-understanding-the-basics)

Essential requirements are a common feature of medical device regulations around the world. At the...

[![](https://www.regtik.com/hs-fs/hubfs/Waving%20Australian%20flag%20in%20Melbourne.jpeg?width=365&name=Waving%20Australian%20flag%20in%20Melbourne.jpeg)](https://www.regtik.com/mdrblog/australian-tga-to-recognise-medical-device-assessments-from-singapores-health-sciences-authority)

 Nov 7, 2022 8:00:00 AM

## [Australian TGA to recognise approvals from Singapore’s HSA](https://www.regtik.com/mdrblog/australian-tga-to-recognise-medical-device-assessments-from-singapores-health-sciences-authority)

Australia’s Therapeutic Goods Administration, the national regulator for medical devices, has...

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 Oct 20, 2022 5:18:30 PM

## [Australian TGA consults on draft borderlines guidance](https://www.regtik.com/mdrblog/tga-seeking-views-on-draft-guidance-boundary-and-combination-products-medicines-medical-devices-and-biologicals)

The Therapeutic Goods Administration (TGA) – the national regulator for medical devices in...

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