How Medical Devices Are Classified in Australia (and Why It Matters)
Medical device classification is one of the most foundational decisions in bringing a device to market. It determines what evidence you need, how your device is assessed, and the r
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 Product Registration – KD&A’s Tips and Tricks
If you wish to sell medical devices in Australia, the Therapeutic Goods Administration (TGA) require you to include the device on the Australian Register for Therapeutic Goods (ART
TGA Time Frames – How Long Should You Wait?
Are you waiting to hear from the TGA about your new medical device or IVD application? Maybe it’s an application audit response…. read on for more information about TGA time fr
Mutual Recognition Agreement Amendments 2013: How Do They Affect Device Registration
The Mutual Recognition Agreement between Australia and the European Union (EU), the EC MRA, facilitates medical device sponsors (entities or individuals who place medical devices o
