Medical Technology Regulation


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 Australian medical device or IVD manufacturer or sponsor there are some key websites which allow you to have valuable and reliable information at your fingertips.  The sites below are worth adding to your favourites list.   The Therapeutic Goods Administration website acts as an excellent resource, providing information such as the Australian Regulatory Guidelines for Medical Devices and IVD guidance......

Continue Reading


The Next Phase of the Global Harmonisation Task Force (GHTF) Evolution...

Recently there has been significant discussion on the future direction of the GHTF. In a statement released on March 28 2011, Larry Kelly, the chair of the GHTF,  confirmed that the current GHTF structure will morph into a Regulator’s Group. This was considered the best way to continue to work towards the objective of harmonised regulatory requirements by GHTF senior officials....

Continue Reading


In an effort to improve the process for listing, evaluating and funding new medical technology, the Australian Government Department of Health and Ageing recently completed a review of health technology assessment (HTA) agencies in Australia. To be listed on the Australian Medicare Benefits Schedule (MBS), a new medical procedure must be submitted to Medical Services Advisory Committe (MSAC) for an HTA....

Continue Reading


Greater scrutiny for in-vitro diagnostic (IVD) devices In-vitro diagnostic (IVD) device companies will soon be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs into line with medical devices by requiring standard technical documentation (STED) and in some cases, a full quality system....

Continue Reading