Instructions For Use for Medical Devices
Overview
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe.
The Therapeutic Goods Act 1989 and associated supporting legislation set out the regulatory requirements for medical devices. This includes the information to be provided with a medical device through product label and Instructions for Use (IFU) and the format it must be provided in. The IFU is the information provided by the manufacturer for the intended user detailing how the device can be used safely for its intended purpose. For implanted medical devices, further information is available to patients in the form of patient information leaflets (PIL) and patient implant cards (PIC).
We are seeking feedback on how IFU are provided, and whether electronic IFU (eIFU) should be made available in more flexible format.
Why your views matter
The feedback received through this consultation will contribute towards further strengthening of the regulatory framework related to IFU for medical devices and the format in which it is made available. Please download and read the consultation paper available as attachment at the bottom of this page for information on the proposals.
The survey:
The proposals are listed in a questionnaire format for your feedback. Click on the link ‘Consultation Questions’ available at the bottom of this page to provide feedback. On the ‘Introduction’ page, there are questions seeking information about yourself and a mandatory question regarding consent to publish your feedback. After you finish responding to questions on this page, click on ‘Continue’ button to view questions on the next page. Respond to the questions on the page ‘Instructions for Use for Medical Devices’ and click on ‘Continue’ button to move to the next page ‘Submit Document’. If you wish to submit your response through a document or attach supporting document, click on the ‘Choose File’ button on the ‘Submit Document’ page. Click ‘Continue’ button to submit your response through the ‘Almost Done…’ page. Your response will not be submitted until you click on ‘Submit Response’ button on the ‘Almost done…’ page.
Average time to complete the survey is 10 minutes.
Please contact the TGA by email at: devicereforms@tga.gov.au if you have any questions or concerns related to this consultation.
Provide feedback
Audiences
- Anyone from any background
Interests
- Hospitals
- e-Health
- Health technology
- Legislation
- Regulatory policy
- Preventative health
- Strategic Policy
- Policy Development
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