Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41el
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41EL
Character Range: 51150–52485

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 or variation 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
 (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.

Division 3—Suspension of conformity assessment certificates

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)).