Tga Classification Of Medical Devices

What classification is my medical device? | Therapeutic …

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

Medical devices are classified according to the level of harm they may pose to users or ...

Medical devices overview | Therapeutic Goods …

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

Classification of active medical devices (including …

https://www.tga.gov.au/resources/resource/guidance/classification-active-medical-devices-including-software-based-medical-devices

Classification rules Detecting, diagnosing, screening, monitoring, investigation Therapy Recording patient images and anatomical models General rule for any other active …

Medical devices | Therapeutic Goods Administration (TGA)

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

Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. While the objective of these …

Classification of IVD medical devices | Therapeutic …

https://www.tga.gov.au/resources/publication/publications/classification-ivd-medical-devices

Classification of IVD medical devices | Therapeutic Goods Administration (TGA) Classification of IVD medical devices Published 4 December 2020 This guidance on …

Classification of active medical devices (including …

https://www.tga.gov.au/sites/default/files/classification-of-active-medical-devices-including-software-based-medical-devices.pdf

classification rules are discussed in more detail below. 4.2, 4.4, 4.8, 5.7 Classification intended purpose classificationThere are several rules of the device. rulesThe rules for …

Overview of medical devices and IVD regulation

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

TGA assessment of applications for ARTG inclusion. The degree of rigour of the TGA's assessment ...

Australian regulatory guidelines for medical devices …

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

The Principles are in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). Meet safety, performance and quality …

TGA Guidance on Classification of Active Medical …

https://www.regdesk.co/tga-guidance-on-classification-of-active-medical-devices-basics/

The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Classify Your Medical Device | FDA Classify Your Medical Device The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different …