Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:5_1
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 5 cl 1
Character Range: 79325–80101

1  Subsection 3(1)
Insert:
Australian conformity assessment body certificate means a certificate that is issued by an Australian conformity assessment body and that is of a kind mentioned in section 41FIA.
conformity assessment document means:
 (a) a conformity assessment certificate; or
 (b) an Australian conformity assessment body certificate; or
 (c) an overseas regulator conformity assessment document.
overseas regulator has the meaning given by section 41BIB.
overseas regulator conformity assessment document means a certificate or other document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the manufacturer of the device.