Updated Standards to Keep Manufacturer’s Busy
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 t
KD&A’s Guide of Guides – Australia
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 in
Revised Medical Device Definitions Implemented in New Zealand – Effective 1 July 2014
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 definin
TGA Release New Fee Schedule
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.
Medical Device Software – Potential for Consistent Regulation in Asia
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 wit
