The Therapeutic Goods Administration (TGA) has refined its guidance on system or procedure packs (SOPPs) as of January 2024. This revision builds on the foundational document released in November 2021,...
This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive guidance for manufacturers of Specific Devices. This...
The Therapeutic Goods Administration (TGA) is seeking feedback on its proposed fees and charges for the 2024-25 financial year. This consultation allows stakeholders to comment on the potential impact of...
In September 2023, Berlin hosted the 24th IMDRF Management Committee meeting, chaired by the EU and attended by over 550 global participants over five days, revealing significant developments in medical...
Introduction 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 devices operated by gravity...
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 section 42BAA of the Therapeutic Goods...
What is a valid ISO 13485 QMS certificate accepted by the TGA? International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International...
In July 2021 the Therapeutic Goods Administration (TGA) published significant updates to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). Access the current version of the Regulations via the...
Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves...
What does this mean? The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October...