Australian TGA Sponsor Overview
An Australian TGA sponsor must meet the TGA (Therapeutic Goods Administration) standards as per the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. They assist in controlling the registration, quality, and Post-marketing Surveillance (PMS) of medical devices and other healthcare products in Australia. With a physical office in Australia, Freyr serves as an expert sponsor for medical device and IVD firms worldwide.
Freyr Australian TGA Sponsor Competencies:
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Medical device Regulatory experts at Freyr serve as liaisons between your company and the TGA.![]()
Assistance in compliance with the TGA regulation and latest guidance.![]()
End-to-end product registration support for all classes of medical devices and IVDs.![]()
Assist in the renewal of device registrations.![]()
Maintaining and updating of license (as required).![]()
Device post-approval change/variation support.![]()
License transfer support.![]()
Promotional material review.![]()
Local representation.![]()
Support vigilance activities by assisting with the reporting of recalls/adverse events to the TGA in collaboration with companies and distributors.![]()
Post-market Surveillance (PMS) activities.![]()
Regulatory consulting services.
Frequently Asked Questions (FAQs)
- Must be an Australian resident or have a registered legal entity in Australia.
- Understand the TGA's Regulatory obligations for medical devices.
- Ensure manufacturers have an appropriate Quality Management System (QMS), often ISO 13485.
- Provide evidence that the device meets Regulatory standards and requirements.
- Register the device with the TGA and list it on the Australian Register of Therapeutic Goods (ARTG).
- Have systems for monitoring, reporting, and responding to adverse events and recalls.
- Ensure device labeling and advertising comply with the TGA regulations.
- Conduct or ensure ongoing monitoring of the device after it is marketed.
- Possess the financial resources to fulfill sponsor responsibilities, including managing recalls.
Yes, a "third party" sponsor who is not monetarily involved in the sale of the products and only acts as a Regulatory representative in Australia is essential because they:
- Serve as the essential bridge to meeting Australia's TGA standards.
- Establish a local entity accountable for the device's safety and Regulatory adherence, which is crucial for legal and Regulatory purposes.
- Offer indispensable local Regulatory insight, speeding up approval processes and mitigating compliance risks.
- Enable prompt and efficient local monitoring, reporting, and action on safety issues, protecting patients.
- Act as a non-negotiable condition for market entry.
- Guarantee that devices entering the market uphold Australia's high public health and safety standards.
Yes, while this an amicable option, it additionally poses some risks, such as:
- Should you terminate your partnership with the distributor, a new sponsor must be appointed, to initiate the registration process anew. This could lead to significant delays and substantial expenses.
- Distributors, whose focus is on sales, might lack the required Regulatory compliance knowledge to serve as a sponsor efficiently.
- Assigning a distributor as a sponsor could risk conflicts of interest regarding product safety and quality.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
- Independent representation and Regulatory support.
- Continuous liaison with the agency for submissions, queries, and feedback.
- Single point of contact in the country for liaison with Regulatory agency.
