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Australia Reviews Device Classification Rules To Align With EU

 
• By Vibha Sharma

Certain products would be upclassified under new Australian proposals.

Australia - EU
Australia wants to align its medtech rules with the EU • Source: Shutterstock

Australia's Therapeutic Goods Administration is inviting stakeholder feedback on proposals to reclassify or introduce new classification rules for several types of medical devices to ensure their oversight is in line with the new EU regulatory framework. The proposed changes, if adopted, will effectively result in most affected device categories being assigned to a higher risk class than at present.

The proposals are in line with Australia's plan to align its medtech regulatory framework with the EU regulations wherever possible...

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