COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

MEDICAL DEVICE STANDARDS ORDER NO. 1

Medical Device Standards for Clinical Evidence

I, RITA MACLACHLAN, delegate of the Minister for Health and Ageing for the purposes of section 41CB of the Therapeutic Goods Act 1989 and acting under that section, DETERMINE:

(a)           that the matters specified in column 2 of item 1 in the Schedule constitute a medical device standard for all kinds of medical devices, subject to the conditions (if any) set out in column 3 of that item of the Schedule, and

(b)          the matters specified in column 2 of items 2 and 3 of the Schedule constitute a medical device standard for cardiac valve prosthesis and intraocular lenses respectively, and

(c)           medical devices of those kinds that comply with the appropriate standard are to be treated as complying with those parts of the essential principles specified in column 4 of the relevant item of the Schedule.

This Order commences on the day it is gazetted in the Commonwealth Gazette.

Dated this   twentieth                            day of            February                    2003

Rita Maclachlan

Delegate of the Minister for Health and Ageing

Schedule