Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Blood And Tissue Screening Tests Top Australia’s IVD Regulatory Scheme

This article was originally published in The Gray Sheet

Executive Summary

In vitro diagnostics that screen for pathogens in the blood supply or in organ and tissue donations would be regulated as highest-risk Class IV devices under the regulatory framework for IVDs proposed by Australia's Therapeutic Goods Administration (TGA)

You may also be interested in...



Australian IVD Framework Proposal Would Broaden Regulatory Oversight

Australia's proposed regulatory structure for in vitro diagnostic devices would bring new regulatory requirements and costs for a number of products that currently are exempt from oversight

Edgewell Finds COVID Bright Side: Wet Ones On Way To Becoming ‘Little Mega-Brand’

Skin hygiene is one of several categories where Edgewell Personal Care has a “right to win" after 18 months of renovations, according to the company’s 20 November Investor Day presentation. The firm has doubled its production capacity and has plans for a “full suite” of product innovation to build on Wet Ones’ 60% growth in fiscal 2020.

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

UsernamePublicRestriction

Register

LL1134882

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel