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
Regulatory Requirements: The Basic Information for Australian Medical Device Manufacturers
To manufacture and sell a medical device in Australia, you must hold certification from the Therapeutic Goods Administration (TGA). Depending on the risk level of the device you ma
TGA Release Proposal Paper: Are Tighter Controls and Alternative Options for Conformity Assessment Ahead?
The TGA have released a proposal paper introducing changes which could shake things up for Australian and overseas medical and IVD device manufacturers. The paper explores changes
Regulatory Requirements: A Simple Guide for Australian Medical Device Distributors
So you’ve found a new medical device that is just what Australia needs? Follow these steps to better understand the regulatory requirements for selling medical devices in Austral
Early Warning Mechanisms for Australia and New Zealand
The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing a
Export Corporation Penalised $3.1 Million for Illegal Supply
On the 3rd of February 2012 the Federal Court ruled that Export Corporation (Australia) Pty Ltd should pay civil penalties of just over $3.1 million for importing and supplying a n
Changes Afoot for Medical Device Manufacturers in Argentina, Brazil, Colombia and Cuba
The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers
The Australian Government Release a Blueprint for TGA’s Future – How Does This Affect Your Organisation?
The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. Th
IEC 60601-1, 3rd Edition
IEC 60601-1 third edition has become a common subject of discussion for medical device manufacturers in recent times. The third edition of 60601-1 represents an overhaul of the 606
