Medical Device Classification Tga

What classification is my medical device? | Therapeutic …

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

Class Im. lower risk. Medical device regulation basics. Australian regulatory guidelines for medical devices (ARGMD) Application for conformity assessment certificates (forms and guidance. contact the TGA. Class IIa. low-moderate risk Australian Register of …

Medical devices overview | Therapeutic Goods …

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

Australian regulatory guidelines for medical devices …

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

This means that from 28 July 2021, devices that were previously described under regulation 4.1 (those that contain medicines or materials of animal, microbial, …

Classification of active medical devices (including …

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

General rule for any other active medical device; Supporting documents ... [PDF, 348.03 KB] Classification of active medical devices (including software-based medical devices) …

Global Medical Device Nomenclature (GMDN) Terms

https://www.tga.gov.au/global-medical-device-nomenclature-gmdn-terms

the same classification; the same GMDN Term; and; for Class III medical devices, Class AIMD medical devices and Class 4 IVD devices (other than an immunohaematology …

Medical devices regulation basics - Therapeutic Goods …

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

The Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia. Medical devices included …

Overview of medical devices and IVD regulation

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

Medical devices including IVD medical devices are assessed against the Essential Principles and in line with their intended purpose and risk-based classification. The …

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

• An accessory to a medical device is classified separately from the medical device; and • If a medical device is driven, or influenced, by an item of software, the software has the …

Classify Your Medical Device | FDA

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

Classify Your Medical Device. The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped …

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 …