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 specializing in medical devices and IVDs for the Australian market, offering expert guidance on TGA compliance and acting as Australian TGA sponsors for overseas manufacturers.
**Expertise & scope**
* Provides specialist support for TGA Conformity Assessment and European CE Marking processes, guiding manufacturers through technical documentation reviews, QMS audits, and regulator engagement.
* Assists organizations in preparing regulator-ready applications to demonstrate compliance with Australian and European regulatory requirements, aiming to reduce audit risk and streamline market access.
* Offers Australian TGA sponsor services for international medical device manufacturers, acting as the local regulatory representative for ARTG submissions, ongoing compliance, and post-market obligations.
* Develops medical device and IVD regulatory strategy services to plan and execute market entry in Australia and globally, including defining regulatory pathways, classification, approval routes, standards, timelines, and costs.
* Provides ISO 13485 and MDSAP Quality Management System (QMS) creation, implementation, and maintenance services for medical device and IVD manufacturers.
* Offers guidance on TGA Compliance Principles, understanding TGA updates, advertising medical devices, device classification, Essential Principles, IVD classification, AI in medical device regulation, UDI systems, and medical devices containing medicinal substances.
**Reputation / proof points**
* Possesses over three decades of experience in the medical device sector.
* Services cover pathway selection, submission preparation, audit readiness, regulator liaison, and ongoing post-certification support.
KD&A Pty Ltd is a regulatory consultancy specializing in medical devices and IVDs for the Australian market, offering expert guidance on TGA compliance and acting as Australian TGA sponsors for overseas manufacturers.
**Expertise & scope**
* Provides specialist support for TGA Conformity Assessment and European CE Marking processes, guiding manufacturers through technical documentation reviews, QMS audits, and regulator engagement.
* Assists organizations in preparing regulator-ready applications to demonstrate compliance with Australian and European regulatory requirements, aiming to reduce audit risk and streamline market access.
* Offers Australian TGA sponsor services for international medical device manufacturers, acting as the local regulatory representative for ARTG submissions, ongoing compliance, and post-market obligations.
* Develops medical device and IVD regulatory strategy services to plan and execute market entry in Australia and globally, including defining regulatory pathways, classification, approval routes, standards, timelines, and costs.
* Provides ISO 13485 and MDSAP Quality Management System (QMS) creation, implementation, and maintenance services for medical device and IVD manufacturers.
* Offers guidance on TGA Compliance Principles, understanding TGA updates, advertising medical devices, device classification, Essential Principles, IVD classification, AI in medical device regulation, UDI systems, and medical devices containing medicinal substances.
**Reputation / proof points**
* Possesses over three decades of experience in the medical device sector.
* Services cover pathway selection, submission preparation, audit readiness, regulator liaison, and ongoing post-certification support.
Additional information
KD&A Pty Ltd tailors conformity-assessment strategies to device type, classification, and commercial objectives. Their services are designed to help organizations prepare robust, regulator-ready applications, reducing audit risk and supporting timely market access. They emphasize providing sound regulatory advice to save clients time and money, ensuring a clear understanding of applicable requirements early in the process to plan cost-effectively with minimal disruption. The firm's extensive understanding of medical device regulations across different markets ensures accurate and up-to-date information for clients.
Key Highlights
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Acts as an Australian TGA sponsor for international medical device manufacturers.
Source
“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.”
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Specializes in TGA Conformity Assessment and European CE Marking processes.
Source
“KD&A provides specialist support for TGA Conformity Assessment and European CE Marking processes, guiding medical device and IVD manufacturers through technical documentation reviews, QMS audits and regulator engagement to achieve and maintain certification.”
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Offers comprehensive medical device and IVD regulatory strategy services.
Source
“KD&A provides medical device and IVD regulatory strategy services to help manufacturers plan and execute successful market entry in Australia and globally.”
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Provides ISO 13485 and MDSAP Quality Management System (QMS) creation and maintenance.
Source
“KD&A provides ISO 13485 and MDSAP Quality Management System (QMS) creation, implementation and maintenance services for medical device and IVD manufacturers operating in global markets.”
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Possesses over three decades of experience in the medical device sector.
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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Focuses on providing expert guidance on TGA compliance.
Source
“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.”
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Aims to help clients launch products and access new markets.
Source
“Expert Regulatory Consulting Services to help you launch products and access new markets.”
Buyer Snapshot
Best for
- International medical device manufacturers seeking TGA sponsorship
- Companies needing assistance with TGA conformity assessment
- Manufacturers requiring QMS development (ISO 13485, MDSAP)
How engagement typically works
- Collaborative strategy development
- End-to-end regulatory support
- Expert guidance and consultation
Typical deliverables
- TGA Sponsor representation
- ARTG submission support
- Regulatory Strategy Reports
- QMS documentation and implementation
- Conformity assessment strategies
Good to know
- Best when requiring specialized knowledge of Australian TGA regulations for medical devices and IVDs.
HQ:
Sydney, AU
Languages:
English
Timezones:
Australia/Sydney
Claim 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 scope of TGA and CE marking services)
Supports Artg
true
Recall Vigilance Support
true
Onboarding Steps
Implied steps include: defining regulatory strategy, preparing technical documentation, QMS creation/maintenance, conformity assessment, and ARTG submissions.
Australian Entity State
AU
