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Important Changes in the Regulatory Framework for IVDs

In house Class 4 IVDs – new manufacturer’s evidence accepted Goods new for laboratories that manufacture Class 4 in-house IVDs. A new conformity assessment procedure has been introduced. The following options are now applicable: TGA conformity assessment; or TGA issued Good Manufacturing Practice (GMP) licence (satisfying the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products); or NATA accreditation as a medical testing laboratory to ISO 15189 and compliance with the NPACC standard, Requirements for the development and use of......

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