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
Hip, Knee and Shoulder Joint Reclassification – TGA Announce Regulation Changes
In light of the recent PIP breast implant adverse events and other significant device recalls, the GHTF has finalised a new standard called N87 (based on a previous guidance docum
New MEDDEV Documents Released
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
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
What is the ACMD and why should I be interested?
The ACMD stands for the Advisory Committee on Medical Devices, a committee which provides independent medical and scientific advice to the Minister and the Therapeutic Goods Admini
Harmonisation for Australia and NZ on the Horizon
Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The jo
The TGA and Local Representative Requirements
The Therapeutic Goods Administration (TGA) local representative (termed sponsor by the TGA) requirements can be a significant road block for non-Australian based manufacturers. KD&
Six Essential Web Resources, Australian Medical Device & IVDs
The internet is a vast resource and hunting through available information can be time consuming – making it difficult for you to find what you need, when you need it. As an Aust
