Medical devices
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.
Key information
- For information on obtaining market authorisation go to Supply a medical device.
- For information on medical device manufacture go to Manufacture a medical device.
More information
- 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
Latest alerts
- Hazard Alert: Scandinavian Total Ankle Replacement (STAR) Ankle ProsthesisBe alert to an issue affecting all units of the Scandinavian Total Ankle Replacement (STAR) Ankle Prosthesis supplied in the Australian market.
- Forearm Crutch - tall and adult sizesRecall of API Forearm crutches - tall and adult sizes
- Updated information for repaired Philips Respironics Trilogy 100 devicesPhilips Respironics (the manufacturer) detected two problems with corrected Trilogy 100 ventilators
Latest articles
- Medical devices vigilance program pilotWe 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.
- EU MDR transition extensionThe TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
Events and webinars
Latest publications
- National Symposium on Point-of-care Manufacturing of medical devicesRead the meeting summary for the National Symposium on Point-of-care Manufacturing of medical devices, held on 19 June 2023.
- Medical devices manufactured at the point-of-care - Analysis of survey results by sectorAccess our report on medical devices manufactured at the point-of-care - analysis of survey results by sector.
- ACMD meeting statement, Meeting 74, 10 August 2023Read the meeting statement from 10 August 2023 meeting of the Advisory Committee on Medical Devices (ACMD).