The Sponsor Vigilance Self-Assessment Tool (SAT) is a set of questions on your post-market regulatory requirements. It also links resources to support your understanding of these requirements.
The SAT is a component of the Medical Devices Vigilance Program (MDVP) Pilot.
Submitting your SAT response to the TGA is voluntary.
The TGA will select sponsors for MDVP Pilot desktop audits and on-site inspections based on SAT responses and available regulatory information. A desktop audit and on-site inspection complete the three components of the MDVP Pilot.
Completing the SAT
The SAT is accessible on the TGA Consultation Hub. The link has been provided to sponsors who registered for the MDVP Pilot information session.
If you did not attend the information session and still want to take part, email MDVP@health.gov.au.
The SAT is now open and will close 11:59 pm AEST, 27 October 2023.
You will only need to submit one SAT response per sponsor. Even if you hold multiple medical device ARTG entries and/or if you represent more than one legal medical device manufacturer.
The SAT should take around an hour to complete if you have all the information required on hand. It may take longer if you need to get information from your legal manufacturer(s).
Authorised representatives with submitter access in the TGA eBusiness Services (eBS) portal should submit the SAT response.
Remember to keep your authorised contacts up to date on the eBS portal.
Information on the SAT questions
The SAT User Guide will assist you to navigate through the SAT questions. The SAT User Guide is available as an attachment on the SAT landing page on the TGA Consultation Hub.
If you have any questions about the SAT, first refer to the SAT User Guide. Contact us if you need further assistance.
Required questions
Questions marked ‘required’, will need an answer to progress through the SAT.
Some questions have a ‘Not Applicable’ or an ‘Other’ option where you can write your own response in a free text box.
Include only active medical device ARTG entries
Do not include cancelled or expired ARTG entries or other types of therapeutic goods in your response.
English only
The SAT is only available in English and responses must be provided in English.
Next steps
Upon submission, you'll get an acknowledgement and a link a PDF version of your responses. You should keep a copy of your responses as the TGA may need to contact you about your responses.
After reviewing your SAT responses, we will get in touch if you're selected for a desktop audit and on-site inspection.
General updates and feedback will be available on the MDVP webpage.
Contact us
If your question is not answered in the SAT User Guide, email MDVP@Health.gov.au.