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, providing expert guidance on TGA compliance and acting as Australian TGA sponsors for overseas manufacturers.
**Expertise & scope**
* Guidance on TGA compliance and ARTG inclusions.
* Acting as Australian TGA sponsors for international medical device manufacturers, managing ARTG submissions, ongoing compliance, and post-market obligations.
* Specialist support for TGA Conformity Assessment and European CE Marking processes, including technical documentation reviews, QMS audits, and regulator engagement.
* Development of medical device and IVD regulatory strategy reports to define pathways, classification, approval routes, standards, timelines, and costs for market entry in Australia and globally.
* Creation, implementation, and maintenance of ISO 13485 and MDSAP Quality Management Systems (QMS) for medical device and IVD manufacturers.
* Support for internal auditing, audit readiness, and post-market surveillance.
* Expertise in navigating TGA Compliance Principles, including updates and emerging focus areas.
**Reputation / proof points**
* Over three decades of experience in the medical device sector.
KD&A Pty Ltd is a regulatory consultancy specializing in medical devices and IVDs for the Australian market, providing expert guidance on TGA compliance and acting as Australian TGA sponsors for overseas manufacturers.
**Expertise & scope**
* Guidance on TGA compliance and ARTG inclusions.
* Acting as Australian TGA sponsors for international medical device manufacturers, managing ARTG submissions, ongoing compliance, and post-market obligations.
* Specialist support for TGA Conformity Assessment and European CE Marking processes, including technical documentation reviews, QMS audits, and regulator engagement.
* Development of medical device and IVD regulatory strategy reports to define pathways, classification, approval routes, standards, timelines, and costs for market entry in Australia and globally.
* Creation, implementation, and maintenance of ISO 13485 and MDSAP Quality Management Systems (QMS) for medical device and IVD manufacturers.
* Support for internal auditing, audit readiness, and post-market surveillance.
* Expertise in navigating TGA Compliance Principles, including updates and emerging focus areas.
**Reputation / proof points**
* Over three decades of experience in the medical device sector.
Additional information
KD&A Pty Ltd tailors conformity assessment strategies to device type, classification, and commercial objectives, covering pathway selection, submission preparation, audit readiness, regulator liaison, and post-certification support. They assist organizations in preparing robust, regulator-ready applications to demonstrate compliance with Australian and European regulatory requirements, aiming to reduce audit risk, streamline assessments, and support timely market access. Their services are designed to help manufacturers and sponsors understand applicable regulatory requirements early, enabling cost-effective planning and minimal disruption for market launch.
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 ISO 13485 and MDSAP Quality Management System (QMS) creation, implementation, and maintenance services.
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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Develops Medical Device Regulatory Strategy Reports to define market entry pathways.
Source
“Our Regulatory Strategy Reports define the regulatory pathway for your device, including classification, approval routes, standards, timelines, and costs, so you can make confident development and commercial decisions early.”
Certifications & Trust Signals
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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”
Buyer Snapshot
Best for
- International medical device manufacturers seeking TGA sponsorship.
- Companies needing assistance with TGA conformity assessment and CE marking.
- Organizations requiring development or maintenance of ISO 13485/MDSAP QMS.
How engagement typically works
- Collaborative strategy development.
- End-to-end regulatory support.
- Expert guidance and consultation.
Typical deliverables
- TGA Sponsor services
- ARTG submissions
- Regulatory Strategy Reports
- ISO 13485/MDSAP QMS documentation
- Conformity assessment support
Good to know
- Best when engaging early in the product development lifecycle for optimal strategy.
- Requires clear definition of device classification and intended markets.
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 services like TGA conformity assessment, ARTG inclusions, and regulatory strategy)
Supports Artg
true
Recall Vigilance Support
true
Onboarding Steps
Advise to ensure all details are up to date with the TGA through the online TGA Business Service Portal.
Australian Entity State
AU
