Product Sponsor

You cannot supply regulated medical devices in Australia without a locally based representative who can meet ongoing regulatory obligations. A TGA sponsor acts as the formal point of accountability between the manufacturer and the Australian regulator.

This role becomes critical when authorities require rapid access to documentation, clarification of compliance evidence, or immediate action following an incident. Appointing a capable local representative supports continuity of supply while protecting regulatory standing.

Vicki acts as an Agent/Sponsor for a number of international companies who need an Australian based person to be available 24 x 7 to liaise with the Therapeutic Goods Administration (TGA) on all matters relating to the provision of Medical Devices in Australia.
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In particular, Vicki is available on call to liaise with the TGA in response to Recall issues. Many companies employ legal firms to perform this task, but these firms lack specific knowledge of Medical Device Regulation and are quite expensive to engage in.

Many international manufacturers default to legal firms to manage sponsor responsibilities. However, legal providers often approach regulatory obligations from a contractual perspective rather than a compliance one.
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Engaging a dedicated sponsor with direct regulatory experience allows you to address issues efficiently, without unnecessary escalation or cost. This approach supports clear communication with the Therapeutic Goods Administration while keeping regulatory responses aligned with device specific requirements.

As a medical device product sponsor, Vicki provides more than administrative coverage. You gain access to informed regulatory judgement that supports decision making before issues arise. This includes preparation for audits, recall readiness, and structured responses to authority requests.

Acting as a sponsor requires constant availability and familiarity with evolving expectations, particularly when managing overseas manufacturing arrangements.

The role of a Sponsor includes

• being available to the Therapeutic Goods Administration 24 x 7 in case of adverse events;
• be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia;
• have procedures in place, including a written agreement with the manufacturer, to obtain information from the manufacturer when requested by the TGA for certification;​

ensuring that:

• the manufacturer has available sufficient information to substantiate compliance with the Essential Principles or has procedures in place to ensure that such information can be provided from the manufacturer to the TGA within 20 working days;
• an appropriate conformity assessment procedure has been applied to the medical devices;
• the medical device manufacturers have appropriate conformity assessment evidence for the medical device;
• ​invoices for application fees, annual fees, and any audit fees are processed by the manufacturer’s accounts in a timely manner by forwarding any such information to the attention of the manufacturer’s accounts section;

upon request:

• provide documentation relating to the medical device to the TGA;
• deliver samples of the medical device to the TGA;
• allow a person authorized by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located;
• notify the TGA of certain incidents and performance issues;
• ensure the information about the device complies with the regulatory requirements;
• ensure advertising/ promotional material aligns with the Therapeutic Goods Advertising Code;
• monitor the safety and performance of the device during its lifetime;
• report any problems with the device to the TGA and to the users of the device;
• recall and/or correct devices that have defects, design flaws, or unacceptable clinical risks or levels of performance;
• notify the TGA so the device can be removed from the ARTG;
• notify the TGA of substantial changes to the design, production or intended performance of the device;
• notified in writing by the appropriate legal representative, within 3 months of the event occurring, if the manufacturer:
  • dies
  • is declared bankrupt
  • is a body corporate that is wound up.
• pay annual charges for maintaining a medical device on the ARTG

Ongoing sponsor support helps you maintain confidence that obligations remain under control as products mature in the market. Clear oversight reduces the likelihood of missed deadlines, incomplete submissions, or delayed responses. Working with an experienced TGA sponsor allows you to focus on manufacturing and distribution while regulatory responsibilities are managed with consistency and care.

If you are seeking a dependable Australian based sponsor who understands regulatory expectations in practice, Vicki Partridge offers structured support tailored to international manufacturers managing Australian market access.