How to ensure medical devices applications are processed swiftly

15 December 2008

Providing complete and correct information at the time of lodging your application will assist with the turnaround for processing. If the TGA has to ask for more details, then the application will take longer. Guidance on the key information requirements include:

1. Has your device been correctly classified?

The manufacturer is to provide the Australian sponsor with the classification of the device.

2. Does the intended purpose align with how the manufacturer intends the device to be used?

The intended purpose is specified in the advertising brochures, labelling and any other material provided with the product.

3. Does the manufacturer have the appropriate certification?

See: Australian Regulatory Guidelines for Medical Devices (ARGMD)

4. Does the device meet the Essential Principles for safety and performance?

See: Essential Principles checklist

5. Does the clinical evidence provided demonstrate the device's efficacy?

See: Australian Regulatory Guidelines for Medical Devices (ARGMD)

Further information

To further assist you in providing the correct information with your application see the Therapeutic Goods (Medical Devices) Regulations 2002.