IVD guidance documents

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 devices@tga.gov.au.

A C D I R S T U W

A

• 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

C

• Class 1-3 in-house IVDs: using the online application form
  Guidance to assist sponsors of class 1-3 in-house IVDs fill out the online application form in TGA Business Services
• Class 4 in-house IVDs: using the online application form
  Guidance to assist sponsors of class 4 in-house IVDs fill out the online application form in TGA Business Services
• Classification of IVD medical devices
  IVDs are classified according to the health risk that may arise from an incorrect result
• Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices
  Guidance to assist sponsors of IVDs with clinical evidence
• 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)
• Cyber security for medical devices and IVDs
  Cybersecurity is an important consideration for medical devices and IVD medical devices (IVDs)

D

• Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices
  Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs

I

• 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
• IVD companion diagnostics
  Guidance on regulatory requirements for IVD companion diagnostics

R

• Reduction of assessment fees for medical devices
  Eligibility requirements and procedures to determine whether assessment fees can be reduced
• Regulatory requirements for in-house IVDs in Australia
  This guideline will assist laboratories manufacturing in-house IVDs to fulfil the Australian regulatory requirements

S

• Software as in vitro diagnostic medical devices (IVDs)
  The definition of an IVD medical device in the Therapeutic Goods (Medical Devices) Regulations 2002 includes software

T

• 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

U

• Updating an existing Class 1-3 in-house IVD notification
  Guidance to assist sponsors with updating their exisiting class 1-3 in-house IVDs notification within the TGA Business Services portal

W

• 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