Medical devices & IVDs

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Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.

Medical devices regulation basics
General information about how medical devices are regulated in Australia
IVD medical devices regulation basics
General information about how in vitro diagnostic medical devices (IVDs) are regulated in Australia
Standards, guidelines & publications
Standards, guidelines and publications about the regulation of medical devices and in vitro devices
Forms for medical device & IVD sponsors
Links to forms for sponsors of medical devices and in vitro diagnostic medical devices
Medical devices reforms
The TGA has begun work on a series of reforms to the regulation of medical devices
Regulatory decisions & notices
Links to regulatory decisions about medical devices and in vitro devices, e.g. advertising exemptions

Contact details for enquiries about medical devices or IVDs

If your enquiry is not about medical devices or IVDs, see: Contact the TGA

Email:	devices@tga.gov.au
Phone:	1800 141 144 (freecall within Australia) and select from the following 4 options: press 1: For enquires about Applications to include Medical devices or Notifications to lodge Manufacturer's evidence press 2: For Manufacturers who are applying for Conformity Assessment Certificates press 3: For queries regarding In Vitro Diagnostics press 4: For queries regarding Clinical trials and Special Access Scheme use of unapproved 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
Fax:	+61 2 6232 8785
Post:	Office of Devices Authorisation, TGA, PO Box 100, Woden ACT 2606, Australia
Street address (for deliveries)	Therapeutic Goods Administration 136 Narrabundah Lane Symonston ACT 2609 Australia

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Medical devices & IVDs

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Contact details for enquiries about medical devices or IVDs

Safety information

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