Tga Medical Device Classification Rules

What classification is my medical device? | Therapeutic …

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

Based on your selections, the classification of your medical device is Class Is. About Class ...

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 …

Applying the classification rules - Therapeutic Goods …

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

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 …

Overview of medical devices and IVD regulation

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

The classification rules for medical devices are prescribed in Schedule 2 and Schedule 2A of the MD Regulations and outlined in the ARGMD. Classification of medical devices …

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 intended purpose classificationThere are several rules of the device. rulesThe rules for active Detecting, diagnosing, screening, monitoring, have medical that …

Re-classification of software based medical devices

https://www.tga.gov.au/re-classification-software-based-medical-devices

All new applications for inclusion of software based medical devices in the Australian Register of Therapeutic Goods (ARTG) must meet these new classification rules. For …

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 …

Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2017C00534

Part 7—Exempting medical devices from inclusion in the Register Part 8—Obtaining information Part 9—Fees Part 10—Miscellaneous Part 11—Transitional …

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. …