Australia Regulatory Framework Medical Device registration

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Australian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Australian market:

Major Regulations

Therapeutic Goods MD Regulation 2002
Therapeutic Goods Regulations 1990
Therapeutic Goods Act 1989

General Guidance Documents

Document Year
Australian Regulatory Guidelines for Medical Devices (ARGMD) 2011

IVD Guidance Documents

Application audit (technical file review) of IVD medical device applications2011
Class 1-3 in-house IVD notification2017
Class 4 in-house IVD application2016
Classification of IVD medical devices2015
Conformity assessment overview2011
Conformity assessment procedures for immunohaematology reagents2012
Medical device cyber security guidance for industry2019
Medical device cyber security information for users2019
Medical device cyber securityFact sheet2019
Including IVD medical devices in the ARTG2010
IVD companion diagnostics2019
Reduction of assessment fees for medical devices2015
Regulatory requirements for in-house IVDs2018
Software as in vitro diagnostic medical devices (IVDs)2013
The use of GMDN codes for IVD medical devices in Australia2010
Updating an existing Class 1-3 in-house IVD notification2018
What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs2011

Forms and Applications

Medical Devices Essential Principles Checklist (PDF)2019
Notification: Transfer of sponsorship following death, bankruptcy or winding up 2016
Notification: Transfer of sponsorship following transfer/assignment of business or interest in therapeutic goods2016
Notification: Change of sponsor name2016
Declaration of conformity templates (medical devices)
Schedule 3, Part 1 clause 1.8 (full quality assurance procedure)
Schedule 3, Part 3, clause 3.5 (verification)
Schedule 3, Part 4, clause 4.7 (production QMS)
Schedule 3, Part 5, clause 5.7 (product QMS)
Schedule 3, Part 6, clause 6.6 (conformity procedures)
Schedule 3, Part 7, clause 7.5 (procedure pack or system)
Declaration of conformity templates (IVDs)
Class 4 in-house IVD medical devices
Full quality assurance procedure
Production QMS
Conformity Clause 6.6
Procedure pack or system

Additional Information

Schedule of fees and charges 2019


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