TGA
We no longer accept ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a Declaration of Conformity under the EU IVD Directive before 26 May 2022.
IVD medical devices that are already approved for supply based on ISO 13485 certificates will need to transition to another form of acceptable manufacturer evidence once the certificate expires, to continue to supply in Australia.
This guidance helps sponsors identify the actions they must take to transition to new manufacturer evidence and ensure ongoing regulatory compliance.
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