Australia’s Therapeutic Goods Administration (TGA) is seeking comments from the MedTech industry and regulators on the use of marketing approval by comparable overseas regulators for medical devices in overseas markets to support the inclusion of them in the Australian Register of Therapeutic Goods (ARTG).
The TGA has been directed by the Australian government to review regulations and reduce ‘red tape’ where possible. The TGA says it is specifically seeking feedback on criteria for identifying comparable overseas regulators to allow consideration of its market authorisation decisions, as well as identifying overseas designating authorities that are comparable to the TGA to allow confidence in the third parties it designates.
As part of its process, the TGA will consider the risks associated with the devices and will not reduce the level of oversight on high risk devices.
The consultation period closes on 30 June 2017. Click here
for details on how to submit comments. Once finalised, the comparable overseas regulator criteria and implementation arrangements will be published on the TGA’s website. Contact us
today for more information and to discover how regulatory intelligence and registration management system LICENSALE.COM®
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