An Insight Into Medical Device Requirements in Kenya
The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices. The docum
TGA Launches NEW Improved website – Find documents and guidance more easily
On 4 May 2011 the TGA is going to launch its new website. A site map and navigation guide have been released by the TGA to assist users, these documents can be found on the website
TGA Release Additional IVD Guidance
New IVD requirements (Regulations implemented on July 1, 2010) have brought a number of challenges for IVD manufacturers and sponsors in Australia. To assist, the TGA have released
Problems with Review and Funding of Medical Technology in Australia
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 revie
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
