Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Big Changes Kicking In Under Australia’s Personalized Medical Devices Rules

Executive Summary

Most of the products currently supplied under Australia’s custom-made medical device exemption will no longer be eligible for supply in this way.

You may also be interested in...



Australia Tries Again At Tightening Personalized And 3D-Printed Device Rules

The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.

New EU Filings

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug

The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT143316

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