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.

Note
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.

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 and notification forms
  Guidance to assist sponsors of class 4 in-house IVDs fill out the online application form in TGA Business Services
• Classifying in-vitro diagnostic medical devices (IVDs) for supply in Australia
  IVDs are classified according to the health risk that may arise from an incorrect result
• Completing Conformity Assessment for immunohaematology reagents (IHRs)
  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)
• Completing a Declaration of Conformity for Class 1 medical devices
  Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs.

I

• Including in-vitro diagnostic (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

M

• Meeting clinical evidence requirements for in-vitro diagnostic (IVD) medical devices
  Guidance to understand how we interpret regulations and how manufacturers can comply with them.

P

• Preparing for technical file review (application audit) for in-vitro diagnostic medical devices
  Guidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.

R

• Reduction of assessment fees for medical devices
  Eligibility requirements and procedures to determine whether assessment fees can be reduced

T

• TGA Conformity Assessment overview for in vitro diagnostic medical devices
  Information on Conformity Assessment of in vitro diagnostic medical devices (IVDs).
• 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

• Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)
  Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
• Understanding Conformity Assessment for in-vitro diagnostic medical devices
  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
• Understanding regulation of software as in-vitro diagnostic medical devices (IVDs)
  When software is classified as an in vitro medical device and how it is regulated.
• Updating an existing Class 1-3 in-house IVD notification
  Guidance to assist sponsors with updating their existing class 1-3 in-house IVDs notification within the TGA Business Services portal