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Application and market authorisation for medical devices

Guidance and information about how to submit an application and our evaluation processes and application fees for medical devices.

Bringing a new medical device to market starts with early-stage work like product design and testing. It is worth considering how you will meet your regulatory obligations as part of your initial design process.  
  

You may need clinical data to prove safety and performance. This is especially true for higher-risk devices.  
  

Strong research and development will help you meet regulatory requirements, get market entry and build consumer trust.    
 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about medical devices, and specific types of medical devices. You may also have to meet obligations that apply to all products.

Application pathways and processes

Find application routes to market approval.

Pre-submission planning

Access requirements for pre-submission planning and meetings.

Fees and charges

Understand fees, exemptions and how to make payments.

Global Medical Device Nomenclature

Access the correct GMDN terms for devices.

Product changes and variations

Access information to vary products and sponsorship.

Product types