Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 38B

  (1)   The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations   (2) and (3).

  (2)   Subject to subregulation   (3):

  (a)   to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and

  (b)   each member of the committee must have either or both of the following:

  (i)   medical or surgical expertise in one of the fields mentioned in subregulation   (4);

  (ii)   expertise in at least one of the fields mentioned in subregulation   (5).

  (3)   One member of the committee may have expertise in consumer health issues.

  (4)   For the purposes of paragraph   (2)(a) and subparagraph   (2)(b)(i), the fields are as follows:

  (a)   anaesthetics;

  (b)   cardiology;

  (c)   cardiothoracic surgery;

  (d)   dentistry or oro - maxillofacial surgery;

  (e)   ear, nose and throat;

  (f)   gastroenterology;

  (g)   neurology;

  (h)   obstetrics or gynaecology;

  (i)   ophthalmology;

  (j)   orthopaedics;

  (k)   pathology;

  (l)   plastic and reconstructive surgery;

  (m)   renal;

  (n)   respiratory medicine;

  (o)   vascular medicine;

  (p)   any other medical or surgical field of expertise that is relevant to the committee's functions.

  (5)   For the purposes of paragraph   (2)(a) and subparagraph   (2)(b)(ii), the fields are as follows:

  (a)   biomedical engineering or biomaterials;

  (b)   epidemiology or biostatistics;

  (c)   general medical practice in Australia;

  (d)   human factors analysis;

  (e)   interventional cardiology;

  (f)   interventional radiology;

  (g)   manufacture of medical devices;

  (h)   medical device software engineering;

  (i)   nursing;

  (j)   any other clinical or technical field of expertise that is relevant to the committee's functions.