Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices
International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The
IVD Regulatory Compliance Deadline
Time is up for the manufacturers and sponsors of IVD devices in Australia. July 1st 2015 is the deadline for the transitional period to ensure compliance with the new regulatory fr
IVD Point of Care Tests Go Under the Spotlight
The Therapeutic Goods Administration (TGA) ACMD (Advisory Committee on Medical Devices) recently held a meeting to review the requirements for IVD Point of Care Tests (class 3 IVDs
New EU IVD Regulations, Potentially In Line with Australian IVD Requirements
The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be pote
Greater scrutiny for in-vitro diagnostic (IVD) devices
In-vitro diagnostic (IVD) device companies will soon be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs
