Tga Guidance Medical Devices

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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 monitoring of device performance and ensure systematic investigation of failures …

Standards, guidelines & publications (medical devices

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

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical …

Medical devices | Therapeutic Goods Administration (TGA)

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

Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it. Listen. Medical devices include a wide range of products, …

Active medical devices | Therapeutic Goods …

https://www.tga.gov.au/resources/resource/guidance/active-medical-devices

Active medical devices Download PDF [434.41 KB] Download Word [7.47 MB] Active medical devices are a subset of devices that use energy to operate. This document …

Guidance on Therapeutic Goods (Conformity …

https://www.tga.gov.au/guidance-therapeutic-goods-conformity-assessment-standard-quality-management-systems-order-2019

Two key requirements of the conformity assessment procedures for medical devices are that a manufacturer must implement: a Quality Management System (QMS) for the …

Medical device cyber security guidance for industry

https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices/medical-device-cyber-security-guidance-industry

This guidance has been produced in order to support Australia's medical device cyber security capability, embedding improved cyber security practices across the …

Real world evidence (RWE) and patient reported …

https://www.tga.gov.au/real-world-evidence-rwe-and-patient-reported-outcomes-pros

Updates to the Clinical Evidence Guideline for Medical Devices. The TGA has revised the Clinical Evidence Guideline for Medical Devices to offer some …

Real world evidence and patient reported outcomes – …

https://www.tga.gov.au/real-world-evidence-and-patient-reported-outcomes-medical-devices

Potential of Unique Device Identification (UDI) The TGA is implementing a Unique Device Identification system for Australian medical devices. When fully implemented, the label …

TGA Publishes Guidance Documents for …

https://www.emergobyul.com/news/tga-publishes-guidance-documents-reclassified-medical-devices

The guidance documents address the following categories, with their new classifications provided alongside: Active medical devices for therapy with a …

Boundary and combination products guidance

https://consultations.tga.gov.au/tga/boundary_and_combination_products_guidance/

This consultation process is your opportunity to contribute to helping the TGA deliver guidance that strengthens Australia’s regulatory framework for all therapeutic …

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