Commonwealth Numbered Regulations

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4. Regulation 35 (Therapeutic Device Evaluation Committee)
  4.1   Subregulations 35 (2) and (3):
Omit the subregulations, substitute:

"(2) The functions of the Committee are:

   (a)  to give advice to the Minister or the Secretary in respect of:

        (i)    the safety, quality, efficacy, manufacture, use and
               availability of therapeutic devices:

                (A)  imported, or to be imported, into Australia; or

                (B)  to be exported from Australia; or

                (C)  supplied within Australia; and

        (ii)   the priorities, policies and procedures that should be applied
               to the administration of the Act and these Regulations in
               relation to therapeutic devices; and

        (iii)  matters raised by sponsors or other persons about decisions or
               actions in relation to:

                (A)  the supply, use or modification of therapeutic devices;

                (B)  information provided on therapeutic devices; and

        (iv)   drugs, to the extent that matters referred to in subparagraph
               (i), (ii) or (iii) are involved; and

   (b)  to give advice to other persons or bodies, in accordance with a
        direction in writing of the Minister, in relation to matters on which
        the Committee has given advice under paragraph (a).

"(3) Subject to subregulation (3A), the Committee consists of at least 6, and
not more than 9, persons appointed in writing by the Minister from persons
each of whom is eminent in his or her profession and has qualifications and
expertise in one or more fields relevant to the functions of the Committee.

"(3A) In making appointments to the Committee, the Minister:

   (a)  must ensure that at least 4 members are medical practitioners; and

   (b)  must not appoint a person with expertise in a particular field if
        there are already 2 members who have expertise in that field.". 

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