Medical Device Consulting Services for Australia

Emergo Group helps medical device and IVD manufacturers obtain regulatory approval from the Australian Therapeutic Goods Administration (TGA). We can assist you with many quality assurance, regulatory compliance and distribution management issues in Australia, including those listed below.

Australian TGA Sponsor Representation

Emergo Asia Pacific Pty. Ltd. can act as your independent regulatory "Sponsor" in Australia.

Medical Device and IVD Registration with the Australian TGA

We can assist with registering your medical device or IVD in the Australian Register of Therapeutic Goods (ARTG).

Summary Technical Document (STED) Preparation for Australian Device Approval

The TGA accepts new device applications in STED format and we can prepare and submit one to the TGA for you.

Australia Clinical Research Consulting

If you are considering Australia for clinical research, we can assist in selecting a CRO or managing the trials.

Medical Distributor Search in Australia

Our team of distribution specialists can find and qualify medical distributors in Australia.