Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41EL

Conditions imposed after issuing a conformity assessment certificate

             (1)  The Secretary may, by written notice given to a manufacturer in respect of whom a conformity assessment certificate has been issued:

                     (a)  impose new conditions on the certificate in respect of:

                              (i)  one or more kinds of medical devices covered by the certificate; or

                             (ii)  the manufacturer's quality management system; or

                     (b)  vary or remove existing conditions.

The power may be exercised at the request of the applicant for the certificate or on the Secretary's own initiative.

             (2)  The imposition, variation or removal of a condition under this section takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury--on the day on which the notice is given to the person; or

                    (aa)  in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                   (ab)  in the case of a removal to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                     (b)  in any other case--on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (3)  For the purposes of paragraphs (2)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

Note:       Suspension of a conformity assessment certificate leads to suspension from the Register of the kinds of medical devices to which the certificate applied (see subsection 41GF(1)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).



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