Tga Medical Devices Register

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Medical devices & IVDs | Therapeutic Goods …

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

Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X …

Searching the Australian Register of Therapeutic Goods …

https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/searching-australian-register-therapeutic-goods-artg

The publicly accessible version of the Australian Register of Therapeutic Goods (ARTG) is the reference database of the Therapeutic Goods Administration …

Medical devices | Therapeutic Goods Administration (TGA)

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

Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it. Listen. Medical devices include a wide range of products, …

Medical devices overview | Therapeutic Goods …

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

How does the TGA approve medical devices? A sponsor of a medical device must apply to the TGA to include their device on the Australian Register of Therapeutic Goods …

Medical device inclusion process | Therapeutic Goods …

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good-0/supply-medical-device/medical-device-inclusion-process

Medical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'. Page Find out the …

Australian regulatory guidelines for medical devices …

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

Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure Electronic Instructions for Use - eIFU Patient implant …

Medical device application processing times

https://www.tga.gov.au/resources/resource/guidance/medical-device-application-processing-times

Medical device applications are already subject to two statutory timeframes under the Therapeutic Good Act 1989 (the Act) and further information can be found in the Medical …

Step-by-Step Guide for How to Register Your Medical …

https://www.regdesk.co/register-medical-device-australia/

The TGA has established the Australian Regulatory Guidelines for Medical Devices (ARGMD), which closely resembles the regulations put into place by the European Union. Before starting the …

Medical Device & IVD Registration with Australian TGA - Emergo

https://www.emergobyul.com/services/medical-device-registration-australian-tga

The Australian Sponsor is responsible for device registration (ARTG listing) and post-market activities, such as adverse incident reporting and recalls. The Australia Sponsor’s …

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