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Medical Device Registration Consultant

Medical Device Registration In Australia

Companies that have already acquired market access in Europe will find the TGA process much easier because Australia recognizes CE Marking. In fact, most foreign companies seeking market access in Australia already have CE Marking. However, even if the medical device or IVD has CE Marking, it must still be registered with the TGA and receive an ARTG listing number. There is also a mandatory audit for certain device classifications.

The devices are classified as Class I (Measuring and sterile) , Class IIa, Class IIb and Class III . 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.

Australia in-country representation for medical device companies:

Companies without an established place of business in Australia must appoint an in-country representative, known as an Australian Sponsor. The Australian Sponsor is responsible for device registration (ARTG listing) and post-market activities, such as adverse incident reporting and recalls.

We can assist with Australia TGA Medical Device Registration

With an experienced team in India , Operon is fully equipped to help you access Australias thriving medical device market. Our experienced consultants have experience with conformity assessments for a broad range of device types. Heres 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 clinical summary (a TGA requirement).
  • Submit device applications to the TGA.
  • Act as your Australian Sponsor to the TGA.