Tga Medical Device Register

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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 devices included in the ARTG have sponsors, who take legal responsibility for their supply in or from Australia. The sponsors of medical … See more

Medical devices & IVDs | Therapeutic Goods …

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

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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 …

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 …

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 device inclusion process | Therapeutic Goods …

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

TGA Business Services (TBS) Set up your TBS account and manage applications and ARTG entries - information for sponsors and manufacturers. Submitting an application …

Australian regulatory guidelines for medical devices …

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

Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards …

Medical device application processing times

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

Report on TGA processes and timeframes for the regulation of medical devices and access to market: International benchmarking (pdf,609kb) As outlined in the report, conformity …

Australia Medical Device Registration - TGA Approval

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

Australia Medical Device Registration - TGA Approval Medical Device Registration and Approval in Australia General country-specific regulatory information is …

Medical Device & IVD Registration with Australian TGA - Emergo

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

The TGA uses a four-tiered classification system based on risk to the human body, with ascending risk assigned to Classes I (including sterile and measuring), IIa, IIb, and III, …

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