Understanding Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal Origin Substances
Recombinant, or Animal Origin Substances Recent regulatory updates for medical devices containing medicinal, microbial, recombinant, or animal origin substances took effect on 1 Ju
TGA Recall Reforms: A Closer Look at the PRAC
Earlier this month, we shared an update on LinkedIn regarding the Therapeutic Goods Administration (TGA) recall reforms and the introduction of the Procedure for Recalls, Product A
KD&A Can Help You From the Start – Medical Devices Steps to Market
Do you have a medical device and don’t know what to do? Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical devic
New Regulatory Changes for Medical Devices Containing Medicinal Substances, Animal, Microbial, or Recombinant Materials
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
Navigating the Updates to TGA Guidance on Excluded Software and Essential Principle 13B
In July 2024, the Therapeutic Goods Administration (TGA) released significant updates to their guidance documents on Excluded Software and Essential Principle 13B. These updates ai
Updates to Medical Device Regulations
Various changes have been made to the regulation of numerous types of medical devices by the TGA, including software-based medical devices, prescription spectacle lenses, medical d
Updated Guidance – System or Procedure Packs
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 relea
Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template
This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive gui
TGA Fees and Charges Proposal 2024-25
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
Highlights from the 24th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Berlin, Germany
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 d
