Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.2

Applications

  (1)   An Australian corporation may apply to the Secretary for a conformity assessment body determination in respect of the corporation.

  (2)   The application must:

  (a)   be made:

  (i)   in writing; and

  (ii)   in a form (if any) approved under subregulation   (4); and

  (iii)   in a manner (if any) approved under subregulation   (4); and

  (b)   be delivered to an office of the Department specified under subregulation   (6).

  (3)   The application is not effective if:

  (a)   the application does not meet the requirements of subregulation   (2) and regulation   4A.4; or

  (b)   the application contains information that is false or misleading in a material particular; or

  (c)   the application fee for the application has not been paid.

Note 1:   For the application fee, see regulation   9.1 and Part   1 of Schedule   5.

Note 2:   A conformity assessment body determination assessment fee is payable under Division   9.2 for assessment of the application.

Forms and manners

  (4)   For the purposes of subparagraph   (2)(a)(ii) or (iii), the Secretary may, in writing, approve a form or manner for making an application for a conformity assessment body determination.

  (5)   The Secretary may approve different forms and manners for different classes of conformity assessment body determinations.

Offices

  (6)   For the purposes of paragraph   (2)(b), the Secretary may, in writing, specify an office of the Department to which applications for conformity assessment bodies must be delivered.

  (7)   The Secretary may specify different offices for different classes of conformity assessment body determinations.



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