Fecha: 28/04/2010
Idioma: Inglés
Procedencia: Australian Government - Department of Health and Ageing
Ubicación: Australia


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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