Resource Library for Medical Device Professionals

13 total results. Show all resources.

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 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

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

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

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

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