Global Regulatory Solutions for International companies
Expert advice for manufacturers, sponsors & distributors
Achieve a smoother path to market with KD&A
International Medical Device Manufacturers
You can be confident that your Australian regulatory compliance will be expertly managed and maintained.
To place a medical device or IVD on the Australian market, non-Australian based manufacturers must appoint a local sponsor and obtain Australian Register of Therapeutic Goods (ARTG) Inclusions/Australian TGA certification.
The sponsor’s role is to act on your behalf in all TGA related situations, including any compliance issues that may arise resulting from the sale of your products on the Australian market. The sponsor’s details must appear on product labelling or packaging.
While any Australian resident or registered business can play the role of a sponsor, it is prudent to select a sponsor familiar with TGA regulations. You need to know that you can rely upon your sponsor to react appropriately and within mandatory response times. KD&A can provide guidance to ensure your elected sponsor understands the requirements of Australian sponsors if required.
We are TGA agents and sponsors who are experts in the Australian medical device and IVD market. With KD&A as your TGA agent and/or sponsor, you can be confident that Australian regulatory compliance will be expertly managed and maintained.
Recommended Route for Regulatory Compliance
Prior to supplying your medical device on the Australian market KD&A recommend the following additional services.
Australian Medical Device Companies, including IVD companies.
At KD&A we specialise in designing ISO 13485 Quality Management Systems and Technical Files for medical devices and providing support with the TGA Conformity Assessment process.
Australian Sponsors and Distributors
KD&A can guide your organisation in demonstrating TGA regulatory compliance in the most effective way, to reduce the burden on your organisation and the time to market.
International Medical device companies, including IVD companies
KD&A as an expert regulatory consultant, has significant experience with the global regulatory process for medical and IVD devices and can provide a complete medical device solution.
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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Kea Dent
Managing Director
Bibiana Franco
Senior Associate
Louise Pirauo
Associate
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Assistant
