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Conformity assessment procedures for immunohaematology reagents

Version 1.0, February 2012

29 February 2012

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Kinds of IVD medical devices

Medical devices must be included in the ARTG as a kind of medical device. Section 41BE (1) of the Therapeutic Goods Act 1989 (the Act) specifies that IVDs are taken to be "of the same kind" as another IVD if they:

  1. have the same sponsor; and
  2. have the same manufacturer; and
  3. have the same device nomenclature system code (i.e. GMDN code); and
  4. have the same medical device classification; and
  5. are the same in relation to any other characteristics prescribed in the Regulations.

Regulation 1.6 prescribes that, for the purposes of section 41BE (1) (e), a characteristic of Class 4 IVDs other than IHRs is the unique product identifier given to the device by the manufacturer to identify the device and any variants.

Therefore, IHRs from any of the risk classes can be grouped for entry in the ARTG if they:

  1. have the same sponsor; and
  2. have the same legal manufacturer; and
  3. nominate the same Level 2 collective term; and
  4. are from the same IVD risk class.

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