Six Essential Web Resources, Australian Medical Device & IVDs
The Therapeutic Goods Administration website acts as an excellent resource, providing information such as the Australian Regulatory Guidelines for Medical Devices and IVD guidance documents.
The Australian ComLaw website provides access to full copies of the Therapeutic Goods (Medical Device) Regulations 2002 as amended along with other Acts and Regulations.
The Therapeutic Goods Advertising Code Council (TGACC) website provides information regarding requirements for advertising materials in Australia for therapeutic goods.
The Health Technology Assessment (HTA) website provides an overview of the current Australian Government HTA processes used to inform decisions about the registration of health technologies for use in Australia, and reimbursement under Australian Government funding programs.
Although the future of the Global Harmonisation Task Force (GHTF) is changing, this website still provides practical guidance documents which are well recognised.
Finally, there are a number of industry association websites which can be accessed from the TGA website.
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