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
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).
Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition – What is required by the May 2020 deadline?
Some manufacturers who have existing medical device MDD certificates may not transition before May 2020 and retain their current MDR until expiry, however a significant change to t
Importance of Data Integrity and Document Management
In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibili
Advertising – What’s Required? All the Info You’ll Need for Australia and New Zealand
In the world of marketing, it is very easy to forget that there are legal requirements associated with the advertising of therapeutic goods. Medical device suppliers and manufactur
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 Extend Reclassification Transition Deadline
The TGA have announced an extension to the deadline for the reclassification of hip, knee and shoulder joints. The due date for final transition has been extended by one year to 30
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
