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1990 No. 394 THERAPEUTIC GOODS REGULATIONS - REG 35

Therapeutic Device Evaluation Committee
35. (1) The Therapeutic Device Evaluation Committee is established.

(2) The functions of the Committee are:

   (a)  to make medical and scientific evaluations of therapeutic devices that
        the Minister or the Secretary refers to it for evaluation; and

   (b)  to make medical and scientific evaluations of other therapeutic
        devices if, in the opinion of the Committee, it is desirable that it
        should do so; and

   (c)  to make medical and scientific evaluations of drugs that the Minister
        or the Secretary refers to it for evaluation; and

   (d)  to give such advice to the Minister or the Secretary about the
        importation into, the exportation from and the manufacture and
        distribution within, Australia of therapeutic goods that have been the
        subject of evaluation by the Committee; and

   (e)  to give advice that has been given to the Minister or the Secretary
        under paragraph (d) to such persons or bodies as the Minister directs.

(3) The Committee consists of not less than 6 and not more than 9 persons
appointed in writing by the Minister from persons at least 6 of whom are
expert in one or more of the following disciplines:

   (a)  anaesthetics;

   (b)  bioengineering;

   (c)  biomaterials;

   (d)  dentistry;

   (e)  epidemiology;

   (f)  intensive care;

   (g)  medicine;

   (h)  microbiology;

   (i)  ophthalmology;

   (j)  pharmaceutics;

   (k)  surgery;

   (l)  nursing.

(4) The Minister is to appoint, in writing, a member of the Committee to be
its chairperson.

(5) The Committee may appoint sub-committees, consisting of members of the
Committee and other persons, to inquire into, and report to the Committee on,
any matter that is within the functions of the Committee. 


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