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Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
In a previous article (available here), we provided an overview of Australia’s Prescribed List, the medical device reimbursement process…
While not all applications for inclusion of a device on the Australian Register of Therapeutic Goods (ARTG) are subject…
The Therapeutic Goods Administration (TGA) Unique Device Identification (UDI) system has been in development for several years with several…
Following several years of industry complaints regarding the process for obtaining private health insurance reimbursement authorization for devices and…
Australia has long been considered a market where device CE certification has presented the easiest pathway to entry for…
As in other jurisdictions, the Therapeutic Goods Administration (TGA) has established several requirements related to medical device vigilance reporting…
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