The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26 May 2023.
This means that the TGA can no longer accept ISO 13485 certificates to support IVD inclusion applications.
Approved IVD medical devices supported by ISO 13485 certificates remain valid until the certificate expires. Sponsors will then need another form of acceptable manufacturer evidence to support their approved device; other documentation may be found at this link.
The TGA will publish guidance on the transition to new manufacturer evidence for IVD medical devices soon.
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