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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 4 IVDs

A TGA-issued Conformity Assessment (CA) Certificate is required for all Class 4 and Class 4 in-house IVDs before they can be included in the ARTG. As prescribed in Regulation 3.6A, the conformity assessment procedures that must be applied to Class 4 and Class 4 in-house IVDs are either:

  1. Full quality assurance procedures as per Schedule 3, Part 1 including clause 1.6 (examination of design); or
  2. Type examination procedures (Schedule 3, Part 2) and production quality assurance procedures (Schedule 3, Part 4).

A conformity assessment certificate for full quality assurance procedures (Part 1, excluding clause 1.6) or for production quality assurance procedures (Part 4) can be provided for the full range of IVDs produced by a single manufacturer, regardless of whether they are of the same or different risk class. However, separate conformity assessment certificates are issued under clause 1.6 (examination of design) for each kind of medical device.

IHRs that are Class 4 IVDs, and therefore subject to design examination, will be of the same kind if they are produced by the same manufacturer, have the same Australian sponsor, and reference the same GMDN L2CT code.

Scenario:

A manufacturer produces a range of blood grouping antisera with the following specificities: anti-A, anti-B, anti-A,B, anti–Rh(D), anti-C, anti-c, anti-E, anti-e, anti-K, anti-Jka, anti-Jkb, anti-Fya and anti-Fyb. An Australian sponsor markets the full range of antisera in Australia and New Zealand, and because they are all the same kind of IVD, they can be grouped together for assessment and inclusion in the ARTG as a Class 4 IVD using CT887 - Immunohaematology blood grouping antisera IVDs. The manufacturer is required to apply to the TGA for a conformity assessment certificate under Part 1, including clause 1.6. Following a successful assessment process, the TGA will issue a QMS certificate and a Design Examination certificate that are suitable to use as manufacturer’s evidence to support an application for inclusion of the full range of Class 4 blood grouping antisera IVDs in the ARTG.

The manufacturer also produces a range of reagent red blood cells intended for use in pre-transfusion testing. Their products include a kit containing red blood cells for performing ABO reverse groups; a set of three characterised red blood cells for performing antibody screens on potential transfusion recipients, and a kit containing an 11-cell panel of characterised red blood cells for identification of allo-antibodies detected in a patient's specimen. Each of the reagent red blood cells are classified as Class 4 IHRs under Rule 1.2(2), and can be grouped as the same kind IVD using the L2CT CT886 - Reagent red blood cell IVDs.

Before these products can be included in the ARTG and supplied in Australia, the manufacturer must submit to the TGA an application for a conformity assessment certificate under clause 1.6 only (for examination of design) if the original QMS certificate issued by the TGA to the same legal manufacturer continues to remain current. At the pre-assessment stage of an application for examination of design, the TGA will confirm that the scope of the initial QMS certification remains appropriate.

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