Summary of the TGA’s Guidance Document for Active Medical Devices
The TGA’s August 2023 guidance focuses on requirements for active medical devices, which are defined as devices that significantly convert energy to operate. This excludes device
New guidance documents published – Australian Therapeutic Goods Advertising Code
The Therapeutic Goods Advertising Code (the Code) sets out the rules which govern advertisement of therapeutic goods to Australian consumers. This regulatory framework made under s
Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices
International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The
Australian Medical Device Conformity Assessment Regulations updated by the TGA
In July 2021 the Therapeutic Goods Administration (TGA) published significant updates to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
TGA’s Medical Device Regulatory Changing Landscape
In 2020, the TGA are implementing a range of changes to the medical device regulations due to a number of reasons; some of which include changes to the European device regulations
Road to registering your medical device in Australia
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take ef
KD&A’s Guide of Guides – Australia
The world of medical device regulation is a complicated one. There is a lot of guidance documents available, but it’s very difficult to tell which will be useful and practical in
TGA Release New Fee Schedule
Are you planning on lodging a new medical device application with the TGA and wondering what fees apply to you? The TGA have published the new fee schedule for 2014/2015.
TGA Fees & Timeframes – MTAA White Paper Bares All
The Medical Technology Association of Australia (the MTAA) has released a white paper on the regulatory burdens medical device companies face in Australia. They key focus of the pa
Planning is Key for Regulatory Success
Planning is a recognised and vital step in the development of any medical device…. planning of design, manufacture, customer requirements … the list goes on. However regulatory
