Expected to improve dramatically time-to-market, a new priority designation process for eligible medical devices has opened with guidance documents from the Australian Therapeutic Goods Administration (TGA).
Published in early January, the guidance outlines the requirements for the new priority review designations for medical devices, including in vitro diagnostics, following the Commonwealth Government’s response to the Expert Review of Medicines and Medical Devices Regulation.
To be eligible, devices must meet three specific criteria that are outlined in the documentation, but in general address an unmet need for a serious condition, using new technology, or for new technology has substantially better safety or performance than what is already available.
The TGA’s guidance includes suggested content of a submission to address the specific criteria. The applicant will need to make a concise, persuasive argument against all three criteria. The TGA will also allow for pre-submission meetings to take place prior to the submission.
The anticipated timeframe for TGA’s assessment and decision making on a designation application is up to 20 working days and the decision is valid for six months.
More information is available at the TGA website.