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Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

Version 1.0, October 2014 - OBPR Reference: 14631

17 October 2014

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Appendix 2 - acronyms and glossary

APA - approved pathology authority

ARTG - Australian Register of Therapeutic Goods

CA - conformity assessment - the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the EPs. A CA provides objective evidence of the safety, performance, benefits and risks for a specific medical device and enables regulatory bodies to ensure that products placed on the market conform to the applicable regulatory requirements.

Cadaveric sample - sample taken from a non beating heart donor

Classification of IVDs - IVD medical devices are classified according to the risk posed to the health of the public or an individual, and relates to the risk of an incorrect result arising from the use of the IVD.

  • Class 1 IVD - no public health risk or low personal risk
  • Class 2 IVD - low public health risk or moderate personal risk
  • Class 3 IVD - moderate public health risk or higher personal risk
  • Class 4 IVD - high public health risk

The same classification rules apply to both commercial IVDs and in-house IVDs.

Design examination - an assessment based on the design and development records produced under the manufacturer's QMS and compiled/summarised into a 'design dossier'.

EP - Essential Principles - a set of principles that define the basic principles for quality, safety and performance of the device

FDA - US Food and Drug Administration

GHTF - Global Harmonization Task Force - was a group of representatives from national medical device regulatory authorities and the regulated industry. The GHTF comprised of representatives from five founding members grouped into three geographical areas, where each actively regulated medical devices using their own unique regulatory framework. The GHTF was superseded by the International Medical Device Regulators Forum (IMDRF) in 2011.

GMP - good manufacturing practice - a set of principles and procedures that, when followed by manufacturers of therapeutic goods to ensure that the products manufactured will meet appropriate quality standards.

In-house IVD - an IVD medical device used within the confines or scope of an Australian medical laboratory or laboratory network that has been developed from first principles, developed or modified from a published source or commercial IVD; or used for a purpose other than that intended by the manufacturer; and is not supplied for use outside that medical laboratory or medical laboratory network.

Intended purpose - the purpose that the manufacturer of the device intends it to be used, as stated in the information provided with the device, the instructions for use, or any advertising material applying to the device.

ISO 13485 - International Standard 13485:2003 for medical devices QMS required for regulatory purposes. ISO 13485 represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

ISO 15189 - International Standard 15189 for Medical laboratories, particularly the requirements for quality and competence. It is the standard against which the QMS will be assessed and the assessment will include review of the validation data for any in-house IVDs that are changed or newly implemented since the time of last audit.

ISO 17025 - International Standard 17025 for accreditation of testing and calibration facilities.

IVD - In vitro diagnostic medical device - a medical device that is:

  1. a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with another diagnostic product for in vitro use and
  2. intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:
    1. giving information about a physiological or pathological state or a congenital abnormality or
    2. determining safety and compatibility with a potential recipient or
    3. monitoring therapeutic measures and
  3. not a product that is:
    1. intended for general laboratory use and
    2. not manufactured, sold or presented for use as an IVD medical device.

NATA - National Association of Testing Authorities, Australia - provides assessment, accreditation and training services to laboratories and technical facilities throughout Australia and internationally.

NPAAC -National Pathology Accreditation Advisory Council - advises the Commonwealth, state and territory health ministers on matters relating to the accreditation of pathology laboratories.

Predicate IVD - a commercial IVD from which an in-house IVD has been developed or adapted.

RIS -Regulatory Impact Statement - a document prepared by a department, agency, statutory authority or board responsible for a regulatory proposal following consultation with affected parties, formalising and documenting some of the steps that must be taken in good policy formulation.

TGA CA - TGA Conformity Assessment - carried out according to ISO 13485:2003. See also CA

Book pagination