Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) The Medical Devices Evaluation Committee is established.
(2) The functions of the Committee are:
(a) to give medical and scientific advice to the Minister or the Secretary in relation to any medical device that the Minister or the Secretary refers to it; and
(b) to give medical and scientific advice to the Minister or the Secretary in relation to any medicines that the Minister or the Secretary refers to it; and
(c) to give medical and scientific advice to the Minister or the Secretary in relation to any other therapeutic goods that the Minister or the Secretary refers to it; and
(d) to give advice to the Minister or the Secretary about the importation into, exportation from, and manufacture, distribution and supply in Australia, of therapeutic goods that have been assessed by the Committee; and
(e) to give advice that has been given to the Minister or the Secretary under paragraph (d) to persons or bodies as the Minister may direct.
(3) Membership of the Committee consists of:
(a) at least 8, and not more than 12, core members; and
(b) at least 8, and not more than 20, associate members.
(4) The Minister must appoint to the Committee:
(a) as core members:
(i) at least 3 persons, each of whom is a medical practitioner eminent in the medical profession and at least 2 of whom are specialists in clinical medicine; and
(ii) at least 1 person with expertise in consumer issues; and
(iii) at least 1 person with expertise in industry issues; and
(iv) at least 1 person who is a biomedical engineer, or who holds a university degree in biomedical engineering; and
(v) at least 1 person with expertise in biomaterials, or who holds a university degree in biomaterial science; and
(b) as associate members:
(i) at least 1 person who is a medical practitioner eminent in the medical profession; and
(ii) at least 1 person who is a biomedical engineer, or who holds a university degree in biomedical engineering; and
(iii) at least 1 person with expertise in biomaterials, or who holds a university degree in biomaterial science.
(5) The Minister must appoint, in writing, a member of the Committee to be its chairperson.
(6) 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 within the Committee's functions.