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
