Tga Register Of Medical Devices

Medical devices & IVDs | Therapeutic …

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

For general postmarket medical device enquiries and adverse event reporting: [email protected]. For medical device annual reports and product reviews: …

Searching the Australian Register of Therapeutic Goods …

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

Medical devices | Therapeutic Goods Administration (TGA)

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

The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are …

Medical devices overview | Therapeutic Goods …

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

A sponsor of a medical device must apply to the TGA to include their device on the Australian Register of Therapeutic Goods (ARTG). A sponsor is a person or company …

Australian Register of Therapeutic Goods (ARTG)

https://www.tga.gov.au/resources/artg

Australian Register of Therapeutic Goods (ARTG) Search the ARTG by name, ID or sponsor. Search results include product name and formulation details, sponsor …

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

Accessing TGA Business Services You will need to have a Client ID and access to the TGA Business Services (TBS) website in order to submit your medical device application. …

Overview of medical devices and IVD regulation

https://www.tga.gov.au/overview-medical-devices-and-ivd-regulation

Any application for inclusion of a medical device in the ARTG must include certain information as required in the application form, including conformity assessment …

Medical devices - Australian Government …

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

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices in Australia. In vitro diagnostic devices In vitro diagnostic (IVDs) are typically …

TGA Guidance on ARTG Registration Step …

https://www.regdesk.co/tga-on-medical-device-inclusion-process-step-by-step/

The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a detailed guidance …