Australia’s Prescribed List: Reimbursement and Application Tiers
In a previous article (available here), we provided an overview of Australia’s Prescribed List, the medical device reimbursement process…
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Understanding TGA Application Audits for ARTG Inclusion
While not all applications for inclusion of a device on the Australian Register of Therapeutic Goods (ARTG) are subject…
TGA UDI System: What Manufacturers Must Know for Compliance
The Therapeutic Goods Administration (TGA) Unique Device Identification (UDI) system has been in development for several years with several…
Australia Prostheses List and Implications for Medical Device Manufacturers
Following several years of industry complaints regarding the process for obtaining private health insurance reimbursement authorization for devices and…
Australia TGA Approval: Leveraging CE Certification and FDA Clearance
Australia has long been considered a market where device CE certification has presented the easiest pathway to entry for…
Medical Device Vigilance Reporting for Australia TGA Compliance
As in other jurisdictions, the Therapeutic Goods Administration (TGA) has established several requirements related to medical device vigilance reporting…
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