News

AUSTRALIA: EU MDR transition extension – June/July 2023

AUSTRALIA: EU MDR transition extension – June/July 2023

  • 2023-06-28 09:52:24

The Therapeutic Goods Administration (TGA) created a plan to help Australian medical device sponsors and stakeholders transition to the new EU Medical Device Regulation (MDR). The EU then extended the transition period, so the TGA reviewed its original plan. An updated strategy guideline has been published by the TGA regarding the transition and reclassification of certain medical devices.

More
AUSTRALIA: EU MDR Transition Web Publication Services – May/June 2023

AUSTRALIA: EU MDR Transition Web Publication Services – May/June 2023

  • 2023-05-24 07:26:30

TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.

If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.

More
QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

  • 2023-02-23 02:33:41

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

More