Classification Medical Devices Tga

What classification is my medical device? | Therapeutic …

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

The following tool will assist in determining the classification of a medical device that is ...

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/sites/default/files/classification-of-active-medical-devices-including-software-based-medical-devices.pdf

The classification original classifications of device may • functionality intended purpose is added or indications change over time; the manufacturer or removeddifferent ; or claims …

Classification of active medical devices (including …

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

Classification of active medical devices (including software-based medical devices)[PDF, 348.03 KB] Classification of active medical devices (including software …

Applying the classification rules - Therapeutic Goods …

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

Classification Rule 1.1 (b) This rule applies to IVDs that are intended to detect infectious agents capable of causing serious disease which: could result in death or long-term …

Medical devices regulation basics - Therapeutic Goods …

https://www.tga.gov.au/medical-devices-regulation-basics

Medical devices regulation basics | Therapeutic Goods Administration (TGA) Medical devices regulation basics Last updated 10 November 2021 How medical devices are …

Classification of IVD medical devices | Therapeutic …

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

4 December 2020. This guidance on the classification of in-vitro diagnostic medical devices (IVDs) is to assist manufacturers to classify their IVDs according to the …

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 …

Classify Your Medical Device | FDA

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

The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. …

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 …