KD&A can assist you organisation with obtaining critical medical device registrations such as EU CE Marking, Australia TGA Conformity Assessment and Australian Register of Therapeutic Goods (ARTG) inclusions, US FDA, Health Canada, UK UKCA, Singapore HSA, etc.
In Australia 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 registration. 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). If your device has CE Marking Certification, Pre-Market Certificate (Japan), Register Entry (Singapore) and MDSAP with the applicable product assessment evidence (510(k), De Novo request or Medical Device License (Canada) this process can be streamlined.
KD&A as an expert regulatory consultant, has significant experience with the medical device registration process. 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.
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 are required. 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 are required. 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.
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