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Conformity assessment procedures for immunohaematology reagents

Version 1.0, February 2012

29 February 2012

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Conformity assessment for Class 2 and Class 3 IVDs

Under Regulation 4.1, a TGA-issued Conformity Assessment (CA) Certificate is required for all IVDs that are manufactured in Australia except for:

  • IVD systems and procedure packs;
  • Class 1 IVDs
  • Class 1, Class 2 and Class 3 in-house IVDs;
  • exempt IVDs.

The minimum conformity assessment procedures that must be applied to Class 2 and Class 3 IVDs that are manufactured in Australia are:

For Class 3 IVDs:

  1. Full quality assurance procedures (Schedule 3, Part 1 excluding clause 1.6); or
  2. Type examination procedures (Schedule 3, Part 2) and production quality assurance procedures (Schedule 3, Part 4).

For Class 2 IVDs:

  1. Full quality assurance procedures (Schedule 3, Part 1 excluding clause 1.6); or
  2. The declaration of conformity (not requiring assessment by Secretary) procedures (Schedule 3, Part 6) and production quality assurance procedures (Schedule 3, Part 4).

For Class 2 and Class 3 IVDs that are not manufactured in Australia, see guideline What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs for information on manufacturer's evidence that is acceptable.

A conformity assessment certificate is not required for Class 1 IVDs. The minimum conformity assessment procedure for Class 1 IVDs is the declaration of conformity (not requiring assessment by Secretary) procedure (Schedule 3, Part 6).

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