IVD
Bringing an IVD to the Australian market means working under the TGA's IVD framework, with a four-tier Class 1 to 4 classification, inclusion on the ARTG via an Australian Sponsor, and - unlike the US - regulation of in-house (laboratory-developed) IVDs.
At Taylored Consultancy Ltd, we make IVD compliance clear and stress-free. From classification and evidence to ARTG inclusion, we help you meet TGA requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, and ready for market.
We determine the correct class (1 to 4) for your IVD, which sets your evidence and audit requirements.
We help you compile analytical and clinical performance evidence, leveraging comparable overseas approvals where the TGA accepts them.
Class 3 and 4 IVDs, point-of-care and self-test IVDs face mandatory audit. We help you prepare and respond.
For laboratory-developed IVDs, we help you meet the TGA's specific requirements.
We build your risk management file to the recognised standard.
We review your labelling and instructions for use against TGA requirements.
We manage ARTG inclusion and help you appoint a local Australian Sponsor to hold the entry.
We help you implement a QMS to ISO 13485, the backbone of IVD compliance.
We help you evidence usability and human-factors work to show your IVD is safe to use.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 13485 - Medical devices QMS
ISO 14971 - Risk management for medical devices
ISO 15189 - Medical laboratories quality and competence
ISO 15197 - Blood glucose monitoring systems
ISO 18113 - IVD labelling and instructions for use
ISO 23640 - Stability evaluation of IVD reagents
CLSI guidelines - Laboratory method validation
IEC 61326 - EMC requirements for laboratory equipment
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
Class 3 and 4 IVDs, plus point-of-care and self-test IVDs regardless of class, face mandatory conformity assessment audit in Australia, a step up from lower classes, which can rely more on manufacturer self-assessment. Audit readiness needs to be built into your technical documentation from the start, not tacked on afterwards. We help clients prepare for and respond to these audits.
Often, yes. The TGA accepts comparable overseas approvals as supporting evidence for many IVDs, which can streamline your path onto the ARTG rather than starting from scratch. It's not a guaranteed shortcut for every class, so it's worth checking exactly what your existing approval covers before assuming it will carry across.
Yes, every IVD included on the ARTG needs a local Australian Sponsor to hold that entry and take on specific regulatory responsibilities in-market. If you're an overseas manufacturer without an Australian presence, we can act as, or help you appoint, your Sponsor.
Yes. Unlike some other markets, Australia does regulate laboratory-developed IVDs (also called in-house IVDs), with the TGA setting specific requirements for the laboratories that develop and use them. This is a common trip-up for labs assuming LDTs sit outside formal oversight, so it's worth checking your obligations early if you're developing tests in-house.
The TGA uses a four-tier system, Class 1 to 4, with your class set by the risk your IVD poses, including factors like whether results directly affect patient management, and the severity of harm from a wrong result. Class determines your evidence burden and whether audit is mandatory, so getting classification right first is essential.
ARTG inclusion is the formal listing that allows your IVD to be legally supplied in Australia, and getting there means satisfying the TGA's conformity assessment requirements for your device's class first. Your Australian Sponsor holds the ARTG entry, but the underlying compliance work of classification, evidence and QMS is what actually determines whether inclusion is granted.
Still have questions? Contact us and we'll be happy to help.
