Austria

Ministry of Health

Australian Government, Department of Health

Regulatory Authority

Australian Therapeutic Goods Administration (TGA)

Medical Device Regulation

Therapeutic Goods (Medical Device) Regulation 2002

Australian regulatory guidelines for medical devices (ARGMD)

Official Language

English

Classification

Medical Device – Class I, Is, Im, IIa, IIb, III

IVD – Class 1, 2, 3 and 4

Registration Process

• Determine classification of the medical device.
• Appoint an Australian TGA Sponsor (for non-Australian manufacturers)
• Prepare Technical File or Design Dossier and Australian Declaration of Conformity.
• Sponsor submits Manufacturer’s Evidence (CE Mark Certificate) in TGA Business Services System.
• Sponsor submits Medical Device Application in TBS System.
• Application fee to be paid.
• TGA will review the submitted Design Dossier as part of Level 2 Application Audit
• TGA grants approval or rejection for the application
• If approval is granted, the Manufacturer can market their product in Australia.