Regulation of medical devices
Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.
If you have an enquiry about medical devices that is not answered by this website, please see the contact details below.
Regulatory guidelines & standards
- What is a medical device?
<http://www.tga.gov.au/devices/overview.htm> - Overview of the medical devices regulatory system
<http://www.tga.gov.au/devices/overview.htm> - Core components of the medical devices regulatory system
<http://www.tga.gov.au/devices/core.htm> - Guidance for medical device manufacturers
<http://www.tga.gov.au/devices/manuf.htm> - Guidance for medical device sponsors
<http://www.tga.gov.au/devices/sponsors.htm> - Enforcement guidelines
<http://www.tga.gov.au/legis/enfguidelines.htm> - Post market activities
<http://www.tga.gov.au/devices/postmarket.htm> - Vigilance & reporting adverse events
<http://www.tga.gov.au/safety/monitoring.htm#devices> - Development of Australian Regulatory Guidelines for Medical Devices (ARGMD)
<http://www.tga.gov.au/devices/argmd.htm>
Regulation of
- Condoms
<http://www.tga.gov.au/devices/condomsreg.htm> - Single use devices
<http://www.tga.gov.au/devices/sud.htm> - Dental products
<http://www.tga.gov.au/docs/html/dentalreg.htm> - Variants for Class III and AIMD medical devices
<http://www.tga.gov.au/docs/html/devguid13.htm> - Medical devices containing animal material
<http://www.tga.gov.au/docs/html/devguid14.htm> - Device/medicine boundary products
<http://www.tga.gov.au/devices/boundary.htm> - Medical devices packaged together
<http://www.tga.gov.au/devices/fs_packtog.htm> - Remote control drug infusion devices via data communication interface
<http://www.tga.gov.au/devices/fs_druginfus.htm> - Medical devices in alternative therapies
<http://www.tga.gov.au/docs/html/devguid7.htm>
Contact details for enquiries about medical devices
If your enquiry is not specifically about medical devices, see: Contact the TGA <http://www.tga.gov.au/contact.htm>
If you are a sponsor and your query is about how to lodge an application electronically, see: Device Electronic Application Lodgement (DEAL)
- Email: cab.medical.device.information@tga.gov.au
- Phone:
- 1800 141 144 (freecall within Australia) and select from the following 4 options:
- press 1: For sponsors with queries regarding Overseas Manufacturers Evidence (ie certifications for overseas manufacturers of medical devices)
- press 2: For sponsors with queries about Application Audits or Manufacturers who are applying for Conformity Assessment Certificates
- press 3: For queries regarding In Vitro Diagnostics
- press 4: For queries of a general nature concerning medical devices
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- 1800 141 144 (freecall within Australia) and select from the following 4 options:
- Fax: 02 6232 8785
- Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia