Tga Medical Device Definition

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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

The amended definitions for medical device and accessory provide additional clarification around certain aspects of "what is a medical device" or "an accessory to a medical device" that were already considered within the scope of the existing definition, but not explicitly stated in legislation. These clarifications incl… 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 …

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 …

Medical devices overview | Therapeutic Goods …

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

Share. Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and x-ray equipment. They differ from …

Overview of medical devices and IVD regulation

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

What is a medical device? Medical devices are defined by section 41BD of the Therapeutic Goods Act 1989 (the Act), and further informed by the Therapeutic Goods (Medical …

What classification is my medical device? | Therapeutic …

https://www.tga.gov.au/resources/what-classification-my-medical-device

active implantable medical device active medical device Note: implantable medical device intended purpose joint replacement medical device ancillary medical device intended …

Regulation of software based medical devices

https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices

The TGA is a founding member of the International Medical Device Regulators Forum (IMDRF), a group of medical device regulators from around the world who meet regularly …

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 …

Digital Medical Devices Regulation: TGA Approach

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 for its proper application) intended, by the …

THERAPEUTIC GOODS ACT 1989 - SECT 41BD What …

http://www5.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s41bd.html

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

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