Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.3

Further information

  (1)   For the purposes of assessing an application for a conformity assessment body determination, the Secretary may, by written notice given to the applicant, require the applicant to deliver specified information or documents:

  (a)   to the office of the Department to which the application was delivered; and

  (b)   within the period, of not less than 10 working days after the day the notice is given, specified in the notice; and

  (c)   in a manner (if any) specified in the notice; and

  (d)   in accordance with regulation   4A.4.

  (2)   For the purposes of assessing an application for a conformity assessment body determination, the Secretary may:

  (a)   by written notice given to the applicant, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the applicant to carry on certification - related activities; or

  (b)   by written notice given to a contractor of the applicant, require the contractor to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the contractor to carry on certification - related activities for the applicant.

Note:   For authorised person , see subsection   3(1) of the Act.

  (3)   If the Secretary gives a notice to a contractor under paragraph   (2)(b), the Secretary must give a copy of the notice to the applicant.



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