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An overview of in vitro diagnostic devices

Information about how therapeutic goods move through the regulatory lifecycle from early product development to post-market for in vitro diagnostic devices (IVDs). 

If you're planning to bring an in vitro diagnostic (IVD) device to market in Australia, this is your starting point. 

You need to understand how IVDs are regulated, the regulatory requirements, and your obligations.

This includes:  

  • determining the intended purpose 

  • selecting the correct risk classification

  • preparing evidence that demonstrates compliance with the safety and performance requirements. 

Preparation is key to making sure your product meets Australian requirements. This also helps avoid any regulatory delays. To gauge your readiness, you can request a pre-submission meeting.

Start by learning your responsibilities and planning each stage of your product’s lifecycle.
  

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

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types