Australia Regulatory Framework Medical Device registration

Australian Medical devices regulation basics

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

Major Regulations

Regulation	Year
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

Document	Year
Application audit (technical file review) of IVD medical device applications	2011
Class 1-3 in-house IVD notification	2017
Class 4 in-house IVD application	2016
Classification of IVD medical devices	2015
Conformity assessment overview	2011
Conformity assessment procedures for immunohaematology reagents	2012
Medical device cyber security guidance for industry	2019
Medical device cyber security information for users	2019
Medical device cyber security –Fact sheet	2019
Including IVD medical devices in the ARTG	2010
IVD companion diagnostics	2019
Reduction of assessment fees for medical devices	2015
Regulatory requirements for in-house IVDs	2018
Software as in vitro diagnostic medical devices (IVDs)	2013
The use of GMDN codes for IVD medical devices in Australia	2010
Updating an existing Class 1-3 in-house IVD notification	2018
What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs	2011

Forms and Applications

Document	Year
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 goods	2016
Notification: Change of sponsor name	2016
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)	2013
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	2017

Additional Information

Document	Year
Schedule of fees and charges	2019

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