Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsItem 2.10A of the table in Part 2 of Schedule 4, as inserted by Schedule 7 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 , applies in relation to the following:
(a) a Class 4 in - house IVD medical device that is manufactured on or after the commencement of this regulation;
(b) a Class 4 in - house IVD medical device that is manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement.