The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue. Recently the Australian and New Zealand governments announced their agreement to cease the Australia...
The following announcement was made in October by the Therapeutic Goods Administration: ‘New regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using...
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...
The world of medical device regulation is a complicated one. There is a lot of guidance documents available, but it’s very difficult to tell which will be useful and practical...
This year will see the introduction of many new or revised harmonised standards relating to medical devices. Harmonised standards are used by medical device and IVD manufacturers to demonstrate compliance...
In preparation for the merge of the Australian Therapeutic Goods Administration (TGA) and New Zealand (NZ) Medsafe, Medsafe have published a change the existing process for defining medical devices and...
The Asian Harmonization Working Party (AHWP) has published a white paper on medical software for comment. The AHWP has developed the paper in conjunction with the EU and the US...
Are you planning on lodging a new medical device application with the TGA and wondering what fees apply to you? The TGA have published the new fee schedule for 2014/2015....
The Medical Technology Association of Australia (the MTAA) has released a white paper on the regulatory burdens medical device companies face in Australia. They key focus of the paper regulatory...
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 manufacturers must comply...