Application audit assessment documentation checklists
The TGA notes that the rate of rejection or lapsing of applications to include medical devices in the Australian Register of Therapeutic Goods (ARTG) is approximately 20%. Furthermore this rate has not dropped significantly during the operation of the new regulatory scheme.
In response to this finding the TGA has previously prepared a document that lists common reasons for the rejection of applications. This document is titled Reasons for rejection of applications for medical devices <http://www.tga.gov.au/devices/rejection.htm>. One aim of this document was to provide sponsors with material to assess the readiness of their applications prior to submission.
In a similar manner the TGA has identified that a Checklist may further aid Sponsors in preparing complete information packages in support of applications requiring an Application Audit. As such, two checklists, referred to as Assessment Document Checklists, have been constructed, one for Level 1 and one for Level 2 Application Audits. Both Assessment Document Checklists have been designed as simple tick-the-box style documents that can be completed in a matter of minutes while simultaneously prompting sponsors to ensure they have compiled an information package containing all required documents. Sponsors can expect to receive an Assessment Document Checklist as part of the letter indicating that their application has been selected for audit and requesting the information required.
The TGA encourages Sponsors to utilise an Assessment Document Checklist as a mechanism for preparing complete information packages in support of applications requiring an Application Audit.