Expert advice for manufacturers, sponsors & distributors

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Global Regulatory Solutions for International companies

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Achieve a smoother path to market with KD&A

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Australian Sponsors and Distributors

List your Medical Device for sale on the Australian market

As a distributor selling medical devices or IVDs on the Australian market, you could be considered a “sponsor” by the Australian regulator, the Therapeutic Goods Administration (TGA). Before selling  medical devices or IVDs in Australia, you are required to obtain TGA certification, known officially as Australian Register for Therapeutic Goods (ARTG) Inclusion.

KD&A is expert on the regulations of medical devices and as a medical device regulatory consultant, KD&A can help you simplify the process for your organisation, resulting in a smoother path to market.

Recommended Route for Regulatory Compliance

Establish an Agreement with the Medical Device Manufacturer

Obtain Copies of Certification and Product Information

Lodge an Application for ARTG Inclusion

Get your IVD or medical device onto the Australian market quickly with a TGA product registration by KD&A. Call us today to discuss your medical device registration/inclusion process in the ARTG to access the Australian market. Find out more information

Promotional Materials Review

Ensure your medical device’s promotional materials (including labelling and packaging) comply with the Therapeutic Goods Advertising Code (TGAC).   Find out more information

Post Market Surveillance System

It is a mandatory TGA requirement and a condition of medical device ARTG inclusion that sponsors complete post market surveillance. KD&A can assist you with the development of a compliant Post Market Surveillance system that is tailored to your organisation.

 

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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.

James McBrayer,

Managing Director & CEO, Cyclomedica Australia Pty Ltd

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.

Sean Crealey,

Director of Operations, CT Healthcare

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.

Graham Howard,

Regulatory Affairs Manager, SPD Development Company

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.

Philip Daffas,

CEO, PainChek

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.”

Dean Libertone,

Compliance Officer, Bodyflow International Pty Ltd

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.”

Orsola Regaglia,

Operations Manager, Elastagen Pty Ltd

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.”

Medhat Eldeeb,

Regional Sales Manager, Opto Global Pty Ltd

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.”

Stewart Bartlett,

COO, Signostics Ltd

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.”

Dr. Matthew Athanassiadis,

Director, Australian Dental Manufacturing Pty Ltd

Our team of experts

Kea Dent

Managing Director

Bibiana Franco

Senior Associate

Louise Pirauo

Associate

Mya Imgraben

Assistant

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