Source: http://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd
Timestamp: 2015-11-29 17:39:32
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Australian regulatory guidelines for medical devices (ARGMD) | Therapeutic Goods Administration (TGA)
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V1.1, May 2011
*Please note: You will notice that some sections of the document are yet to be added. These sections are currently being drafted and the document will be updated once those sections are finalised.
Australian Regulatory Guidelines for Medical Devices (ARGMD) (pdf,2.51Mb)* Australian Regulatory Guidelines for Medical Devices (ARGMD) (Microsoft Word,2.32Mb)* Individual parts of ARGMD
ARGMD Part 1 - Introduction (pdf,1.44Mb)* ARGMD Part 1 - Introduction (Microsoft Word,2.03Mb)* Contents of ARGMD Part 1
Introduction to the regulatory guidelines Fees and charges for medical devices The essential principles Classification of medical devices Conformity assessment overview What a manufacturer needs to know about conformity assessment What a sponsor needs to know about conformity assessment Differences between the Australian and European Union medical device regulatory requirements International agreements ARGMD Part 2 - Pre-market (pdf,901kb)* ARGMD Part 2 - Pre-market (Microsoft Word,4.40Mb)* Contents of ARGMD Part 2
Including medical devices in the ARTG Application audits of medical device applications Information about a medical device Active medical devices Medical devices incorporating a medicine Medical devices containing materials of animal, microbial or recombinant origin Systems and procedure packs Medical devices for export Custom-made medical devices Single-use devices (SUDs) and the reuse of SUDs Access to unapproved medical devices in Australia ARGMD Part 3 - Post-market (pdf,411kb) ARGMD Part 3 - Post-market (Microsoft Word,4.24Mb)* Contents of ARGMD Part 3
Changes to ARTG Inclusions Post-market vigilance and monitoring requirements Recalls, suspensions, cancellations and tampering of medical devices ARGMD Part 4 - Navigation and Reference (pdf,252kb) ARGMD Part 4 - Navigation and Reference (Microsoft Word,3.77Mb)* Contents of ARGMD Part 4
Bibliography Contact Details Glossary Index Top of page
AttachmentSize Australian regulatory guidelines for medical devices (docx)2MB Australian regulatory guidelines for medical devices (pdf)3MB Australian regulatory guidelines for medical devices: Part 1-Introduction (docx)2MB Australian regulatory guidelines for medical devices: Part 1-Introduction (pdf)1MB Australian regulatory guidelines for medical devices: Part 2–Pre-market (docx)4MB Australian regulatory guidelines for medical devices: Part 2 - Pre-market (pdf)900KB Australian regulatory guidelines for medical devices: Part 3–Post-market (docx)4MB Australian regulatory guidelines for medical devices: Part 3–Post-market (pdf)410KB Australian regulatory guidelines for medical devices: Part 4–Navigation and Reference (docx)4MB Australian regulatory guidelines for medical devices: Part 4–Navigation and Reference (pdf)252KB Tags: regulatory guidance
Page last updated: Friday, 24 July 2015
URL: http://www.tga.gov.au/node/5308