Application audits
Australian medical devices guidelines
Guidance document number 2, Version 1.6
This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.
A medical device manufacturer has to demonstrate conformity with the Australian essential principles before a sponsor can make an application for inclusion in the ARTG of that device. The manufacturer must follow a conformity assessment procedure appropriate to the class of the medical device.
Australian medical devices guidelines: 2. Application audits (pdf,142kb)
Contents
- Introduction
- What must be done before an application for inclusion of a medical device is made?
- What does the Act consider to be an application for the inclusion of a medical device on the Australian register of therapeutic goods?
- Which products will be selected for an application audit?
- What does an application audit entail?
- What additional information will be requested?
- Level 1 application audit
- Level 2 application audit
- General requirements for the information to be supplied
- Language
- Units
- Text and drawings
- Written information
- Number of copies
- Presentation
- Pagination
- Indexing, cross-referencing and labelling
- Timeframe for the provision of information
- When will an application selected for an application audit lapse?
- What happens after the TGA decides to issue a certificate of inclusion?
- Attachment 1. Applications for inclusion to be selected for audit by the TGA
- Attachment 2. Essential principles checklist