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.
- 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.
Argmd.pdf1579522771.pdf1.75 MB
Para poder escribir un comentario debe iniciar sesión o darse de alta en el portal.