KD&A Pty Ltd
KD&A Pty Ltd is a regulatory consultancy specializing in medical devices and IVDs for the Australian market. They offer expert guidance on TGA compliance, ARTG inclusions, and act as Australian TGA sponsors for overseas manufacturers.
KD&A Pty Ltd is a specialized regulatory consultancy firm focused on medical devices and In Vitro Diagnostic (IVD) devices. They provide expert guidance and services to manufacturers, sponsors, and distributors navigating the complexities of the Australian Therapeutic Goods Administration (TGA) regulatory framework. Their core services include assisting with TGA Conformity Assessment, CE Marking, and ensuring ARTG inclusions. KD&A is particularly adept at supporting overseas manufacturers by acting as their Australian TGA sponsor and providing essential regulatory support, including establishing an Australian address for devices. The firm stays abreast of evolving TGA regulations, including changes to Essential Principles, IVD classification, and Unique Device Identification (UDI) systems. They offer comprehensive support for developing Technical File Documentation, implementing Quality Management Systems (ISO 13485/MDSAP), and managing post-market surveillance. KD&A aims to help clients achieve regulatory success efficiently, enabling them to launch products and access new markets with confidence. Their expertise covers a wide range of regulatory requirements, from initial device classification and strategy to ongoing compliance and TGA annual invoicing management.
About
**Who they are**
KD&A Pty Ltd is a regulatory consultancy based in Australia, specializing in medical devices and in vitro diagnostic (IVD) devices for the Australian market.
**Expertise & scope**
* Expert guidance on TGA compliance and ARTG inclusions.
* Services as an Australian TGA sponsor for overseas manufacturers, ensuring regulatory compliance and an associated Australian address.
* Assistance with TGA Conformity Assessment Processes, including technical documentation examination and quality management system audits.
* Development of Medical Device Regulatory Strategies to map out market entry requirements and steps.
* Creation and maintenance of Quality Management Systems (QMS) compliant with ISO 13485 and MDSAP.
* Support for global medical device registrations.
* Post-market surveillance.
* Guidance on evolving TGA regulations, including device classification, Essential Principles, UDI systems, and AI in medical devices.
* Assistance with TGA annual invoicing to avoid ARTG cancellations.
**Reputation / proof points**
* Over three decades of experience in the medical device sector, with experience as both a manufacturer and regulatory consultant.
KD&A Pty Ltd is a regulatory consultancy based in Australia, specializing in medical devices and in vitro diagnostic (IVD) devices for the Australian market.
**Expertise & scope**
* Expert guidance on TGA compliance and ARTG inclusions.
* Services as an Australian TGA sponsor for overseas manufacturers, ensuring regulatory compliance and an associated Australian address.
* Assistance with TGA Conformity Assessment Processes, including technical documentation examination and quality management system audits.
* Development of Medical Device Regulatory Strategies to map out market entry requirements and steps.
* Creation and maintenance of Quality Management Systems (QMS) compliant with ISO 13485 and MDSAP.
* Support for global medical device registrations.
* Post-market surveillance.
* Guidance on evolving TGA regulations, including device classification, Essential Principles, UDI systems, and AI in medical devices.
* Assistance with TGA annual invoicing to avoid ARTG cancellations.
**Reputation / proof points**
* Over three decades of experience in the medical device sector, with experience as both a manufacturer and regulatory consultant.
Additional information
KD&A Pty Ltd emphasizes providing critical initial and ongoing support throughout the regulatory process, aiming to ensure clients achieve and maintain device certification efficiently. They highlight their ability to guide clients through applications, audits, and full compliance. The consultancy positions itself as an integral part of their clients' teams, demonstrating enthusiasm and ownership in managing tasks of all sizes. They focus on helping clients understand regulatory requirements early to plan cost-effectively and with minimal disruption, saving time and money in preparing devices for market launch.
Key Highlights
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Specializes in TGA compliance, ARTG inclusions, and acting as an Australian TGA sponsor for overseas manufacturers.
Source
“KD&A can assist overseas manufacturers by providing Australian TGA sponsor services and regulatory support.”
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Offers comprehensive support for TGA Conformity Assessment Processes, including technical documentation and QMS audits.
Source
“KD&A can assist you to successfully work through the TGA and/or CE Marking Conformity Assessment Processes. Including the examination of technical documentation and quality management system audits.”
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Provides creation, implementation, audit, and maintenance services for ISO 13485 and MDSAP Quality Management Systems.
Source
“KD&A supports companies to meet QMS ISO 13485, MDSAP and other applicable requirements through providing QMS creation, implementation, audit and maintenance services.”
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Possesses over three decades of experience in the medical device sector, with expertise as both a manufacturer and regulatory consultant.
Source
“With over three decades of experience in the medical device sector, Kea possesses a wealth of expertise, having worked as both a medical device manufacturer and regulatory consultant”
Certifications & Trust Signals
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Acts as an Australian TGA sponsor, requiring an Australian address for medical devices/IVDs.
Source
“The Australian Therapeutic Goods (Medical Device) Regulations 2002 as amended requires an Australian sponsor and an Australian address to be associated with any medical device/IVD”
Buyer Snapshot
Best for
- Overseas manufacturers seeking TGA sponsorship
- Medical device and IVD companies needing ARTG inclusion
- Businesses requiring TGA compliance expertise
How engagement typically works
- Integral team member approach
- Proactive guidance and support
- Customized regulatory strategy development
Typical deliverables
- TGA Sponsor services
- ARTG inclusion applications
- ISO 13485/MDSAP QMS documentation
- Regulatory Strategy Reports
- Conformity Assessment support
Good to know
- Best when requiring specialized knowledge of the Australian TGA regulatory landscape for medical and IVD devices.
HQ:
Sydney, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
IVD, Laboratory diagnostics
Portfolio:
6-25
Onboarding time:
5–30 days
Pricing model:
Retainer
Starting from:
AUD 3,500
Included services:
Sponsor address and labeling review, ARTG inclusion application preparation and submission, eBusiness Services account setup support, Change notification and variation assessment
Supports Artg:
Yes
Device Classes Supported:
IVD
Evidence Review:
Yes
Australian Entity State:
Australian Sponsors & Distributors
Recall Vigilance Support:
Yes
Additional tga_sponsor_au Details
Device Classes Supported
All classes (implied by TGA regulations)
Supports Artg
Yes
Recall Vigilance Support
Post Market Surveillance mentioned
Onboarding Steps
Implied through guidance on applications, audits, and QMS creation/implementation.
Australian Entity State
AU
