Australian Regulatory Guidelines for Medical Devices

Australian Government - Department of Health and Ageing | 28/04/2010
Tecnología Equipamiento Médico Documentación Documentos Australian Regulatory Guidelines for Medical Devices


The Australian Regulatory Guidelines for Medical Devices (ARGMD) has been developed to:

- provide guidance to assist manufacturers and sponsors of medical devices in meeting the regulatory requirements for legally supplying a medical device in Australia

- help ensure that medical device applications to the TGA meet all the necessary legislative requirements so that applications are processed with minimal delays

- enhance the clarity and transparency of the processes:

- leading to the legal supply of medical devices in Australia
- for meeting the ongoing requirements once a device is available for supply in Australia.


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