Australia Medical Device Approval

Medical devices overview | Therapeutic Goods …

https://www.tga.gov.au/products/medical-devices/medical-devices-overview

The Australian Government has been undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia. An Action Plan for Medical Devices (Action Plan), released in 2019, is a three-part strategy to strengthen Australia’s regulatory system, whilst continuing to be patient focused an… See more

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

We are currently in the process of reviewing and updating the Australian Regulatory Guidelines for Medical Devices (ARGMD). • For information on our regulation …

Medical devices - Australian Government Department of …

https://www.health.gov.au/topics/medical-devices

Medical devices regulation basics - Therapeutic Goods …

https://www.tga.gov.au/medical-devices-regulation-basics

The Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia. Medical …

Medical devices | Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/products/medical-devices

TGA confirms the performance of Australian approved Rapid Antigen Tests with COVID-19 Variants The TGA has confirmed the performance of COVID-19 rapid antigen tests …

Australia TGA Approval Process for Medical Devices - Emergo

https://www.emergobyul.com/resources/australia-tga-regulatory-approval-process-medical-devices

Determine classification using Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. If your device has European CE Marking, …

Medical Device Approval Process In …

https://credevo.com/articles/2020/07/25/australia-medical-device-approval-process/

The approval process for medical devices in Australia involves two steps. Step 1: Pre-market assessment. Conformity assessment ; Step 2: Market …

Australia Medical Device Registration - TGA Approval

https://arazygroup.com/medical-device-registration-australia/

From the 1 st of October and 4 th of December 2020, applicants of class I medical devices (non-measuring, non-sterile) and class 1 IVDs, respectively, need to …

Medical device registration & approval in …

https://www.emergobyul.com/services/medical-device-regulatory-overview-australia

Registering your device with the TGA entails risk-based classification; compliance with quality, safety and performance principles; compliance with regulatory …

Australia MRA - Australian Medical Devices Regulations

https://www.sgs.com/en-ca/services/australia-mra-australian-medical-devices-regulations

Only a few Notified Bodies such as SGS have been approved by the Therapeutic Goods Administration (TGA) under this MRA for the Australian medical devices regulations. …