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Global Medical Device Registrations including ARTG Inclusions/ TGA Registrations
Get your IVD or medical device onto the Australian market quickly with a TGA product registration by KD&A.
KD&A can assist you organisation with obtaining critical medical device registrations such as EU CE Marking, Australia TGA Conformity Assessment and Australian Register of Therapeutic Goods (ARTG) inclusions, US FDA, Health Canada, UK UKCA, Singapore HSA, etc.
In Australia the Therapeutic Goods Administration (TGA) requires that all medical devices (including software as a medical device) and IVDs sold in Australia be included on the Australian Register for Therapeutic Goods (ARTG). This is known formally as ARTG inclusion or TGA registration. To obtain an ARTG inclusion for your medical device or IVD, you need to complete a registration process that varies according to device type and classification (risk profile). If your device has CE Marking Certification, Pre-Market Certificate (Japan), Register Entry (Singapore) and MDSAP with the applicable product assessment evidence (510(k), De Novo request or Medical Device License (Canada) this process can be streamlined.
KD&A as an expert regulatory consultant, has significant experience with the medical device registration process. KD&A can provide your organisation with a complete medical device regulatory solution; one that transforms this difficult process into a trouble-free step on the road to market.
Further information on ARTG inclusion for medical devices can be found below.
Note: supporting technical documentation which complies with TGA requirements must be held for medical devices and IVDs. The TGA may or may not review this documentation, this is dependent on product type and classification.
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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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