Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 28

Tests for determining conformity with a standard or compliance with essential principles

  (1)   Each of the following is a test for determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods:

  (a)   a test specified by the Minister in an order under section   10 of the Act for those goods in relation to that standard; and

  (b)   a test specified in a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia - National Formulary in relation to that standard if:

  (i)   those goods are for use in humans; and

  (ii)   the Minister has not specified a test in an order under section   10 of the Act for those goods in relation to that standard; and

  (d)   a test accepted for the purposes of registration of the goods under Part   3 - 2 of the Act; and

  (e)   any other suitable test that the Secretary requires to be carried out in respect of those goods in relation to that standard.

  (2)   Each of the following is a test for determining whether a particular kind of medical device complies with the applicable provisions of the essential principles:

  (a)   a test specified in a medical device standard or conformity assessment standard for the kind of device;

  (b)   a test accepted for the purpose of issuing a conformity assessment certificate in respect of the kind of device;

  (c)   a test required under paragraph   41FO(2)(d) of the Act as a condition of inclusion of the kind of device in the Register;

  (d)   any other suitable test that the Secretary requires to be carried out in respect of the kind of device for the purpose of demonstrating compliance with the applicable provisions of the essential principles.


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