Archive for November, 2011

Australian regulatory guidelines for medical devices (ARGMD)

Posted on November 30, 2011. Filed under: Uncategorized |

The TGA in collaboration with the medical devices industry sector has developed a consolidated reference document detailing the Australian regulatory requirements for medical devices.

This document has been developed as a guide to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia. The information in this document replaces many of the existing guidance documents and information sheets for medical devices that were on the TGA website.

It should be noted that this document is 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.

This document will continue to evolve over time. Updates/clarifications will be included from time to time. Users should check that they have the most up to date version when referring to this Guidance. Comments and suggestions for future versions are welcomed and should be sent to
Establishing an eBusiness account

Each company must have an eBusiness account with the TGA. Once a company has an eBusiness account, the administrator within the company can establish and maintain individual access for any staff within the company who require it.

If a company does not have a master account then they will need to establish an eBusiness account with the TGA. This is done on the TGA eBusiness website.

Click on the New User section of the page and download the:
Client Details Form – only to be completed if the company does not already have a CLIENT identification number. For first time sponsors, this form must be completed.
EBusiness Access Form – needs to be completed to establish an eBusiness account with the TGA and to obtain an account name and password. Complete these forms and fax them to the TGA on 02 6232 8581. An account name and password will be sent to the email address specified on the form within three working days of the TGA receiving a correctly completed form.
Logging on

Applications are submitted via the TGA eBusiness website.
User instructions

Once logged on, the user will be taken to the medical devices home page, which will provide a number of options.
User documentation

User documentation is available online or can be downloaded and printed. This document gives valuable information and assists in navigating through the various options available.

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