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 certification.

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).

KD&A as an expert regulatory consultant, has significant experience with the ARTG inclusion process for all medical devices (Class I, IIa, IIb, and III) and IVD devices (Class 1, 2, 3 and 4). 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 in Australia.

If your device has CE Marking, MDSAP, 510(k) clearance, etc., this process can be streamlined.

Get your IVD or medical device onto the Australian market quickly with a  TGA product registration by KD&A.

Further information on ARTG inclusion for medical devices can be found below.

CLASS III MEDICAL DEVICE ARTG INCLUSION

To complete this process a valid product certifications such as CE Marking, MDSAP, etc., and an Australian address. KD&A will ensure the product certification is suitable for TGA submission, and then complete all required actions to obtain ARTG inclusion for your Class III medical device.  This process includes obtaining, assembling and submitting documentation provided by the manufacturer to the TGA as part of a TGA Level 2 Audit.

Contact us for a custom quote for your Class III medical device.

CLASS IIA AND IIB MEDICAL DEVICE ARTG INCLUSION

To complete this process a valid product certifications such as CE Marking, MDSAP, etc., and an Australian address.. KD&A will ensure the product certification is suitable for TGA submission, and then complete all required actions to obtain ARTG inclusion for your Class IIa or IIb medical device.

Contact us for a custom quote for your Class IIa and IIb medical device.

CLASS I MEDICAL DEVICE ARTG INCLUSION

To complete this process an Australian address is required. KD&A will complete the application process required to obtain ARTG inclusion for your Class I medical device.

Contact us for a custom quote for your Class I medical device. 

IVD ARTG INCLUSION

KD&A can guide your organisation to demonstrating regulatory compliance with the Therapeutic Goods (Medical Device) Regulations 2002 as amended (which includes IVD’s after amendments in March 2010) in the most effective way, to reduce the burden on your organisation and the time to market. KD&A’s experience ensures your organisation and IVD device have a smooth regulatory process.

Contact us for a custom quote for your IVD .

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.

Have a few questions? Visit our Frequently Asked Questions page.