Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.29

Limiting determinations

  (1)   The Secretary may, by written notice given to an Australian conformity assessment body, vary the body's conformity assessment body determination to limit, or further limit, the determination as mentioned in paragraph   4A.7(4)(b).

  (2)   The Secretary's power under subregulation   (1) of this regulation may be exercised:

  (a)   if the Australian conformity assessment body applies in writing to the Secretary; or

  (b)   on the Secretary's own initiative.

  (3)   A variation under this regulation takes effect on the day specified for the purpose in the notice.

  (4)   The day specified in the notice under subregulation   (3) must be at least 20 working days after the notice is given to the body, unless the body:

  (a)   applied for the variation; and

  (b)   has agreed to an earlier day.

  (5)   For the purposes of subregulation   (4), the earlier day must not be earlier than the day the notice is given to the body.



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