Market authorisation is the approval given to supply a therapeutic good in Australia. In most cases this involves entry of the product in the Australian Register of Therapeutic Goods (ARTG).
If you are a consumer and want information on specific medical devices such as breast implants, transvaginal mesh and cosmetic injections go to Medical devices.
To confirm you have a medical device go to Is my product a medical device?
For manufacturing requirements for medical devices, including IVDs, go to Manufacture a medical device.
- PageMedical device inclusion processSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
- PageUnderstand medical device labelling requirementsInformation for manufacturers and sponsors on meeting medical device labelling requirements.
- PageVary an Australian Register of Therapeutic Goods entry for a medical deviceHow to vary an Australian Register of Therapeutic Goods (ARTG) entry for your medical device.
- PageMedical devices reformsThe Medical Devices Reforms aim to enhance the safety, performance and quality of medical devices in Australia and focus on patient safety.
- PageEU MDR TransitionOverview and management of the EU MDR transition under the Australian regulatory framework.
More information
Laboratory tests
- Regulation of IVDs: laboratory-specific information
- The regulation of nutrigenetic tests in Australia
- HIV testing in Australia
- IVD companion diagnostics
- Specimen collection swabs
- Seasonal Influenza Rapid Antigen Self-tests and Combination tests
Personal protective equipment (PPE)
- Guidance on Personal Protective Equipment for Health Professionals
- Face masks and respirators that are regulated by the TGA
- Evidence requirements for face masks that are medical devices
- Guidance on medical/surgical face masks and respirator standards - key performance aspects
Implantable medical devices
In-vitro diagnostic devices (IVDs)
- IVD medical devices: Definitions & links
- Including IVD medical devices in the ARTG
- Regulatory requirements for in-house IVDs
- Hepatitis B and C viruses IVD self-tests
- Chlamydia, gonorrhoea and syphilis IVD self-tests
- Software as in vitro diagnostic medical devices (IVDs)
- Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)
- Manufacturer evidence for medical devices and IVD medical devices
Unique Device Identification (UDI) system
- UDI Webinar No. 7 - Global manufacturer UDI learnings
- Unique Device Identification Webinar #7 - Global manufacturer UDI learnings, 22 March 2022
- Webinar presentation: Unique Device Identification, 19 April 2022
Resources and presentations
- Useful resources for business and researchers
- Presentation: Engaging with the TGA
- Presentation: Medical device regulatory lifecycle and clinical evidence requirements
- Presentation: Quality control of biotech products - regulatory perspectives
- Presentation: ACCESS consortium in the context of ATMPs
- Presentation: ICH-E2C(R2) guideline and PBRER template
- Presentation: TGA evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims, 2 March 2022
- Australian regulatory guidelines for medical devices (ARGMD), V1.1 - archived
- Overview of medical devices and IVD regulation
Obtain consent to supply a medical device that does not meet all requirements
Topics