AUSTRALIA: PHASE OUT OF ISO 13485 CERTIFICATES FOR IVD MEDICAL DEVICES – JULY/AUGUST 2023
- 2023-07-21 03:49:06
The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.
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