Before any Medical Device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA).
We Can enable you to Enlist your IVD or medical device with the TGA so you can start exporting your products to the Australian market.
Operon Can Assist You To Register Your Medical Devices In Australia:
Is Fully Equipped to help you access Australia’s thriving medical device market. Our experienced consultants have experience with conformity assessments for a broad range of device types. Here’s how we can help:
Assess the Australian TGA registration requirements for your device(s).
Research the proper GMDN codes for your medical device(s).
Conduct a Technical File review to ensure completeness.
Assistance with compilation or review of the clinical summary (a TGA requirement).
Submit device applications to the TGA.
Act as your Australian Sponsor to the TGA.
operon can help with all aspects of the TGA registration process. Your success in Australia is our goal.
Medical Device Classification In Australia:
The TGA uses a four-tiered classification system based on risk to the human body, with ascending risk assigned to Classes I (including sterile and measuring), IIa, IIb, and III, respectively. Like most systems, regulatory control increases with increasing risk level.
Australian classification rules are almost identical to the EU classification criteria and classification in Australia will generally reflect that of the EU.