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The QMN Weekly Bulletin

TGA Proposes to Allow Marketing of Devices Approved Overseas

June 9, 2017

Australia’s Therapeutic Goods Administration is proposing to allow the marketing of devices that have already received marketing approval by certain overseas regulatory authorities.

The TGA is asking devicemakers to comment on which overseas regulators should be considered.

Australia’s medical device regulations closely mirror EU regulations, and the country also participates in the Medical Device Single Audit Program. The TGA is also a founding member of the International Medical Device Regulators Forum, and IMDRF signatories are closely aligned when it comes to device classification, conformity assessments and quality standards.

The TGA also has cooperative agreements with Brazil, Canada, France, Germany, Ireland, Japan, Singapore, the UK and the U.S.

The EU has up-ended its entire medical device oversight system — replacing its three current guidance directives with two massive regulations that bind devicemakers to a variety of new requirements. Understanding the New EU Medical Device Regulations directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the new provisions and what they’ll mean for your business.

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