Tga Registered Medical Devices

Medical devices & IVDs | Therapeutic Goods …

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

Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart …

Medical devices | Therapeutic Goods Administration (TGA)

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

The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are …

Medical devices overview | Therapeutic Goods …

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

Searching the Australian Register of Therapeutic Goods …

https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/searching-australian-register-therapeutic-goods-artg

The publicly accessible version of the Australian Register of Therapeutic Goods (ARTG) is the reference database of the Therapeutic Goods Administration …

Australian Register of Therapeutic Goods (ARTG)

https://www.tga.gov.au/resources/artg

Australian Register of Therapeutic Goods (ARTG) Search the ARTG by name, ID or sponsor. Search results include product name and formulation details, sponsor …

Overview of medical devices and IVD regulation

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

Any application for inclusion of a medical device in the ARTG must include certain information as required in the application form, including conformity assessment …

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 the …

Australia Medical Device Registration - TGA Approval

https://arazygroup.com/medical-device-registration-australia/

From the 1 st of October and 4 th of December 2020, applicants of class I medical devices (non-measuring, non-sterile) and class 1 IVDs, respectively, need to …

Step-by-Step Guide for How to Register Your Medical …

https://www.regdesk.co/register-medical-device-australia/

The TGA has established the Australian Regulatory Guidelines for Medical Devices (ARGMD), which closely resembles the regulations put into place by the European Union. Before starting the …