Tga Definition Medical Device

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Update to medical device definitions and requirements …

https://www.tga.gov.au/resources/resource/guidance/update-medical-device-definitions-and-requirements-system-or-procedure-packs

System or Procedure PacksOther changes to the requirements for systems or procedure packs set out in R…Beauty therapy products such as lasers and IPL devicesFurther discussions are occurring with targeted stakeholders about the … See more

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

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 …

Overview of medical devices and IVD regulation

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

Medical device reforms. Please note the TGA is currently considering a range of changes to the medical devices regulatory framework, including classification …

IVD medical devices: Definitions & links | Therapeutic …

https://www.tga.gov.au/resources/resource/guidance/ivd-medical-devices-definitions-links

Medical Device A medical device is defined in the legislation as any instrument, apparatus, implement, machine, appliance, implant, software, material or other …

Acronyms and glossary terms - Therapeutic Goods …

https://www.tga.gov.au/resources/acronyms-and-glossary-terms

An active medical device (other than an implantable medical device) that is intended by the manufacturer: either: to be, by surgical or medical intervention, introduced wholly, or …

Australian regulatory guidelines for medical devices …

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

The TGA has mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. These requirements facilitate the …

Digital Medical Devices Regulation: TGA …

https://www.qualitymeddev.com/2020/05/27/digital-medical-devices-regulation/

any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary …

Adverse event reporting | Therapeutic Goods …

https://www.tga.gov.au/resources/resource/guidance/adverse-event-reporting

a device, event or issue specifically identified by the TGA as an issue that requires close monitoring - sponsors of devices that are affected will be notified by the TGA when this …

Boundary and combination products guidance

https://consultations.tga.gov.au/tga/boundary_and_combination_products_guidance/

The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and …

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