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Resource Library for Medical Device Professionals

11 total results. Show all resources.
Download the free chart: Australia Regulatory Approval Process for Medical Devices

Australia TGA Regulatory Approval Process for Medical Devices

This chart illustrates the steps in the Australia TGA medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013

Medical Device Consulting Services for Australia

Interested in selling your medical device or IVD in Australia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

May 19, 2008

Medical Device Registration in Australia & New Zealand

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.

6 pages
Nov 12, 2014

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Fill out our short form to request information about Australia

Get smart about Australia in 1 hour

Thinking about entering the Australian market for the first time? Understanding the TGA's regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.

1 page
Jun 5, 2017
Learn about the Australian TGA regulations which apply to medical devices

Australia TGA Medical Device Regulations

A comprehensive list of medical device regulations in Australia with links to the original documents.

Downloadable PDFs
Apr 14, 2008

TGA - Australia Therapeutic Goods Administration

Learn about the regulatory structure in Australia and major medical device regulations.

1 page
Feb 10, 2014
Learn about basic demographic and healthcare market data on Australia

AUSTRALIA – Overview of medical device industry and healthcare stats

A brief look at Australia's medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Aug 28, 2014
Compare the time, cost and complexity of getting regulatory approval for medical devices

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Interactive Page
Aug 25, 2015

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018