KD&A provides end-to-end global medical device and IVD registration services, supporting manufacturers and sponsors to obtain regulatory approvals and market access across Australia and key international jurisdictions.

We guide organisations through complex regulatory pathways – including ARTG inclusions, TGA conformity assessments, EU CE marking, FDA submissions and other international registrations – helping streamline applications, reduce regulatory risk and accelerate time to market.

Drawing on decades of regulatory and manufacturing experience, KD&A designs registration strategies to your device type, classification and commercial goals.

FAQ 1: What is an ARTG inclusion or TGA registration?

In Australia, medical devices and IVDs must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied. This process – often referred to as TGA registration or ARTG inclusion – varies depending on the device classification, technology and available conformity-assessment evidence.

FAQ 2: Can overseas approvals be leveraged for Australian registration?

Yes. Where available, overseas conformity-assessment evidence such as CE certificates, MDSAP audit reports, FDA clearances or approvals, and approvals from other recognised regulators can often be used to streamline the Australian ARTG pathway.

Why global registrations matter

A well-planned registration strategy:

• Enables timely access to target markets
• Reduces regulatory uncertainty and rework
• Supports investment and commercial growth
• Aligns development programs with approval pathways
• Minimises delays from regulator questions
• Supports long-term lifecycle compliance