IVD guidance documents

In vitro diagnostic medical devices

29 February 2012

Related information

Australian Regulatory Guidelines for Medical Devices (ARGMD)

The TGA is developing guidance specific for IVDs as part of the Australian Regulatory Guidelines for Medical Devices (ARGMD). The first of these chapters are now available. Further chapters are under development and are referenced in the current documents. These chapters will be available in the near future. In instances where there is no specific IVD guidance available the corresponding documents from the ARGMD may provide useful information.

Please note that these documents are provided for guidance. All regulatory decisions are made using legislation as set out in the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Any comments on the content of the IVD guidance can be directed to 1800 141 144 or email ODBTConsult@tga.gov.au.

Application audit (technical file review) of IVD medical device applications
For an IVD, an application audit is primarily a review of the manufacturer's technical documentation and will often be referred to as a technical file review
Business rules for reduced assessment fees for IVDs
Information about the business rules that apply to the reduction in assessment fees for IVDs where information allows the assessment to be abridged
Classification of IVD medical devices
IVD medical devices are classified according to the risk posed to the health of the public or an individual, which relates to the risk of an incorrect result arising from the use of the IVD
Conformity assessment overview (IVDs)
A manufacturer must be able to demonstrate that both the in vitro diagnostic medical device (IVD) and the manufacturing processes used to make the IVD conform to the requirements of the therapeutic goods legislation
Conformity assessment procedures for immunohaematology reagents
This guideline addresses some specific requirements in the regulation of immunohaematology reagents (IHRs) that manufacturers and sponsors need to consider when applying conformity assessment procedures or making applications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Fees and charges for IVD medical devices
The TGA is fully cost-recovered and collects its revenue primarily through annual charges, application, evaluation, audit and assessment fees.
Including IVD medical devices in the ARTG
The ARTG is a register of therapeutic goods accepted for importation into Australia, supply for use in Australia, or exportation from Australia
Regulatory requirements for in-house IVDs in Australia
This guideline will assist laboratories manufacturing in-house IVDs to fulfil the Australian regulatory requirements
The use of GMDN codes for IVD medical devices in Australia
The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices
What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
Depending on the classification of a device, there are a number of different conformity assessment procedures a manufacturer may use to demonstrate compliance with the Essential Principles
What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs
Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that an IVD and the manufacturing processes used to make the IVD comply with the Essential Principles and other requirements of the therapeutic goods legislation

Web page last updated: Wednesday, 29 February 2012

URL: http://www.tga.gov.au/industry/ivd-guidance.htm

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