Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41BJ

             (1)  This Chapter does not apply to a medical device if section 15A applies to the device, except for purposes connected with:

                     (a)  applications for including the medical device in the Register under this Chapter; or

                     (b)  including the medical device in the Register under this Chapter.

Note:          Section 15A sets out the circumstances in which Part 3‑2 applies or continues to apply to medical devices.

             (2)  However, if an exemption under section 34 applied to a medical device, or the manufacturer of the device, immediately before the commencement of this Chapter:

                     (a)  Parts 4‑3 and 4‑4, and Division 2 of Part 4‑11, apply in relation to the device after the end of the period of 2 years after that commencement; and

                     (b)  Parts 4‑8, 4‑9 and 4‑10, and Divisions 3 and 4 of Part 4‑11, apply in relation to the device, to the extent that they relate to any of the provisions referred to in paragraph (a), after the end of that period.