Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it.
Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. While the objective of these products is to help improve your health and wellbeing, it's important to know that their use also has potential risks.
Please report any adverse events associated with medical devices.
- Importing & supplying medical devices
- Advice for health procurement teams about therapeutic goods and medical devices
- Off-label use of medical devices: Frequently asked questions
Cyber security of medical devices
- Medical device cyber security information for users
- Medical device cyber security - Consumer information
Action plan for medical devices
- Medical devices reforms: An Action Plan for Medical Devices
- An Action Plan for Medical Devices
- Action Plan for Medical Devices - Progress Report Card: April 2020
- Action Plan for Medical Devices - Progress Report Card: June 2021
Medical device reforms
- Regulatory changes for software based medical devices
- Reclassification of active medical devices for therapy with a diagnostic function
- Reclassification of active implantable medical devices (AIMD)
- Reclassification of medical devices that administer medicines or biologicals by inhalation
- Refinements to the Personalised Medical Device Framework
Australian conformity assessment bodies
- Be alert to an issue affecting all units of the Scandinavian Total Ankle Replacement (STAR) Ankle Prosthesis supplied in the Australian market.
- We are starting a new medical device pilot program to support medical device sponsors to comply with their ongoing post-market surveillance responsibilities.
- Nius Development Pty Ltd fined $26,640 for allegedly importing unapproved cosmetic injectable productsWe have issued infringement notices for $26,640 to Nius Development Pty Ltd for the alleged unlawful import of unapproved cosmetic injectable products.
- The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).