Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 12C

                For subparagraph 15A (5) (a) (ii) of the Act, a kind of medical device is specified if:

                (a)    it is a medical device of a kind that is manufactured in Australia by a person mentioned in column 2 of Schedule 8, as in force immediately before the commencement of the Therapeutic Goods Amendment (Medical Devices) Act 2002 ; and

               (b)    it is manufactured in the circumstances set out in column 3 of that Schedule, as in force immediately before that commencement.

Note    Schedule 8 identifies persons who are exempt from the operation of Part 3‑3 of the Therapeutic Goods Act 1989 in relation to the manufacture or a step in the manufacture of therapeutic goods or a class of therapeutic goods -- see subsection 34 (2) of the Act and regulation 18.