Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:3_5
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 3 cl 5
Character Range: 2601–3477

5  Conformity assessment standardsquality management systems
 (1) This section applies in relation to the manufacture of a kind of medical device, whether or not it is intended by the manufacturer to be supplied in a sterile state.
 (2) The matters specified in a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 1 to this instrument constitute a conformity assessment standard for a quality management system mentioned in Part 1, 4 or 5 of Schedule 3 to the Regulations.
 (3) A quality management system mentioned in Part 1, 4 or 5 of Schedule 3 to the Regulations that complies with a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 1 to this instrument is to be treated as having had applied to it those parts of the conformity assessment procedures specified in column 3 of that item.