Information Feature: TGA Application Audit

As part of medical device framework reforms, the TGA seem to be dramatically increasing the number audits completed on medical device applications for inclusion on the Australian Register for Therapeutic Goods (ARTG).

A bit of background

As a result of the Mutual Recognition Agreement held between Australia and the EU, Australian Sponsors can make device applications using an overseas manufacturer’s European certification (CE Marking to the Medical Device Directive 93/42/EEC) as evidence of compliance with the Australian regulations. This abridged application process means significantly reduced costs and time frames for Sponsors.

However the TGA do hold the right to request further information about a device. This is done via a process called Application Audit. Application Audit is mandatory for some medical devices including all class III devices (in which case the Sponsor is charged a fee for the process) and in other cases, is a way for a TGA assessor to request further information about a particular device and/or application.

What it all means

As it stands today, there are 2 levels of Application Audit; however under current reform proposals this may change to 3 (we’ll let you know when/if this happens!).  Application Audits can either be Level 1 or Level 2. The information requirement is as follows:

Level 1 Application Audit:

The TGA requires a Sponsor/Manufacturer to submit the following within 20 working days.

• Manufacturer’s Australian Declaration of Conformity;
• Copy of the current and latest conformity assessment evidence for the medical device and/or manufacturer (in most cases, this is the CE Marking certificate);
• Information about the device including copies of the:
  • Label/s
  • Instructions for use
  • Advertising materials such as brochures, web pages and advertisements.

Level 2 Application Audit:

The TGA requires a Sponsor/Manufacturer to submit the following within 20 working days.

• All of the documents listed for Level 1 Application Audit above;
• A Risk Management Report;
• A Clinical Evaluation Report;
• Efficacy and Performance Data for medical devices that disinfect including sterilisation of other medical devices.

Application Audit shows just how important it is to ensure that an agreement is made between a manufacturer and Sponsor that any device information and materials requested by the TGA will be supplied as needed.

Help

KD&A have significant experience with Application Audit processes and can guide Sponsors and manufacturers through. To learn more about how KD&A can help you, go to our services pages, or contact us for a personalised quote.