December 13, 2024, The Therapeutic Goods Administration (TGA) of Australia has announced the publication of the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.3) 2024, which reflects transitional measures for IVD products. This determination allows manufacturers to register IVD products in Australia to meet product registration requirements by utilizing the EU CE mark certificate issued under the EU IVDD, in line with the extended transitional period for EU IVDR compliance.
The determination has been updated through an amendment to the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018.
The additional information inserted in this determination specifies the period during which EU IVDD-issued CE mark certificates can be used for IVD product registration in Australia:
- for Class 2 IVD products, until January 1, 2030
- for Class 3 IVD products, until January 1, 2029
- for Class 4 IVD products, until January 1, 2028
Please refer to the attached document below.
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