Resource Library for Medical Device Professionals

13 total results. Show all resources.

This video about the Australia medical device market gives an overview of the regulatory framework and registration process basics.watch now

Video | 4 minutes

This video series about the Australia medical device market shows you the process and identifies the key concepts to know before you begin.watch now

Video | 16 minutes

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

Process Chart | 2 pages

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

White Paper | 6 pages

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.watch now

Video | 7 min

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.view all

Market Data | 1 page

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.view all

Service Overview | Varies

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

Market Data | 1 web page

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

Process Chart | Interactive Page

Read by 50,000+ device professionals worldwide. Stay updated on changes to global medical device regulations.view all

 

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

Device Regulation | Downloadable PDFs

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

White Paper | 8 pages

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

Market Data | 1 page