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Australian TGA Sponsor Services
With KD&A as your TGA agent and/or sponsor, you can be confident that Australian regulatory compliance will be expertly managed and maintained.
KD&A provides Australian TGA sponsor services for international medical device manufacturers, acting as the local regulatory representative and supporting ARTG submissions, ongoing compliance, and post-market obligations.
FAQ 1: Do international medical device manufacturers need an Australian TGA sponsor?
Yes. International medical device manufacturers must appoint an Australian-based TGA sponsor to submit ARTG applications and meet ongoing regulatory obligations in Australia.
FAQ 2:What does a TGA sponsor do?
A TGA sponsor acts as the local regulatory representative, responsible for ARTG submissions, communication with the TGA, post-market compliance, incident reporting, and maintaining regulatory documentation.
FAQ 3: Can KD&A act as our TGA sponsor?
Yes. KD&A provides Australian TGA sponsor services for international manufacturers and supports regulatory strategy, submissions, and ongoing compliance activities.
FAQ 4: Do we need a TGA sponsor before applying for ARTG inclusion?
Yes. A TGA sponsor must be appointed before an ARTG application can be submitted and remains responsible for regulatory obligations throughout the product lifecycle.
FAQ 5: Does KD&A support sponsor transfers?
Yes. KD&A assists with TGA sponsor transfers, including regulatory assessment, documentation, and coordination with the TGA to ensure a smooth transition.
Why Choose KD&A as Your Official TGA Sponsor
- Deep local regulatory knowledge – we understand how the TGA interprets and applies compliance requirements.
- End-to-end sponsor support – from ARTG application submission to post-market regulatory commitments.
- Global manufacturer focus – we support companies from Europe, North America, Asia and beyond entering the Australian market.
- TGA communications handled for you – we act as your voice with the regulator, minimising risk and delays.
We pride ourselves on providing excellent
customer service to our clients
Cyclomedica Australia Pty Ltd
In the 2.5 years we have been working together, no task or challenge is too small or too big. They take both extremes with enthusiasm and ownership not often seen with other consultants. In fact, we don’t see them as consultants, they are an integral part of our team.
CT Healthcare
We have found KD&A’s service, support and understanding invaluable in helping to guide our business through different situations that have arisen. Their work has been done in an extremely professional, efficient and prompt manner, which has been important in situations where immediate action has been needed.
SPD Development Company Ltd
In the 5 years we have been working together, we have found KD&A to be helpful, knowledgeable and always professional. Their ability to provide clear, accurate and timely responses to regulatory enquiries has been valuable to our business.
PainChek
We have found KD&A’s services to be solution driven, the team is professional and efficient. I highly recommend KD&A regulatory services and expertise.
Bodyflow International Pty Ltd
“KD&A provided Bodyflow with professional, informative and relevant regulatory advice. In addition, the workshop I attended (held by KD&A along with two other regulatory consultants) allowed for interactive learning – growing my understanding of the requirements for our medical device.”
Elastagen Pty Ltd
“KD&A have provided invaluable quality management system and regulatory support as Elastagen has successfully transitioned from an R&D organisation to a clinical stage medical device company operating in compliance with ISO 13485 & 21CFR820. KD&A have been by our side from day 1 and are always available to help with any of our regulatory questions.”
Opto Global Pty Ltd
“KD&A have been providing Opto global with high quality and professional assistance for 5 years. Their service is delivered efficiently, thoroughly and within the required timeframe.”
Signostics Ltd
“We have used KD&A’s services since our inception. Initially, KD&A managed the creation of our quality system, which they implemented quickly and efficiently. Since the initial engagement we have grown and employed quality and regulatory managers, with KD&A continuing to provide quality management and regulatory affairs advice. They have always been responsive and totally professional in their approach and dealings. We have no hesitation in recommending them.”
Australian Dental Manufacturing Pty Ltd
“We could not help but come away with respect for, and impressed with, the service KD&A provided to our company. I would not hesitate in recommending KDA to anyone who needs to deal with TGA regulatory requirements.”
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