Medical devices reforms: Class I low risk medical devices

Project overview

The regulation of low risk Class I medical devices is still under review, to remove unnecessary regulation while ensuring these products are appropriately regulated.

Completed work includes:

• introduction of a Class I application fee, to provide resources for review of Class I entries in the ARTG (this commenced 1 July 2018)
• review of the Therapeutic Goods (Excluded Goods) Order 2011, which has been replaced by the Therapeutic Goods (Excluded Goods) Determination 2018 and the Therapeutic Goods (Declared Goods) Order 2019.
• Advice for health procurement teams about therapeutic goods and medical devices

Ongoing work includes:

• collaborating with the Low Risk Devices Working Group of industry stakeholders to develop guiding principles for determining which products are very low risk and therefore should be excluded from regulation, including Products used for and by people with disabilities.
• review of existing Class I medical devices in the ARTG to ensure they meet the requirements for inclusion, with product types identified as not meeting these requirements to be removed from the ARTG.
  • As part of this review the TGA has developed a self-assessment tool to determine if a product is a medical device. This tool is also available to potential applicants at Is my product a medical device?.
  • This review has also prompted Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices, which aims to improve the integrity of the ARTG and reduce the number of incorrect inclusions.

For more information about consultations on reforms to low risk devices, visit Medical device reforms: Low risk products.

Guidance for industry

For general guidance on Class I medical devices see:

• Overview of medical devices and IVD regulation
• Is my product a therapeutic good?
• Is my product a medical device?
• What classification is my medical device?

For more information about other reforms visit Medical devices reforms.