Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) (Fourth Edition 2018)

This document was published by the National Pathology Accreditation Advisory Council (NPAAC) whilst under the governance of the Department of Health and Aged Care. From 1 July 2021, the Australian Commission on Safety and Quality in Health Care (the Commission) assumed responsibility for coordinating the National Pathology Accreditation (NPA) Scheme and supporting the development of the pathology accreditation standards.

Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) (Fourth Edition 2018) is currently in use.

The Commission is undergoing a review process for each of the pathology standards. To remain up to date on upcoming consultations and to provide input, please visit the pathology accreditation standards and sign up now for ongoing updates.

For enquiries about the NPA Scheme or the resources, email pathology@safetyandquality.gov.au.

The Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (IVDs) (Fourth Edition 2018) outlines the principles and assessment criteria by which in-house IVDs must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia.

The revised Requirements have been reviewed to reflect the current regulatory requirements for in house IVDs and provide clarification of the levels of evidence for scientific validity.

An image of the front cover of Tier 3B Requirements for the Development and use of In-house In Vitro Diagnostic Medical Devices (IVDs) (Fourth Edition 2018)

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Publication year
2022
Resource type
Publication, report or update
Topics