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.