Information deficiencies in applications requiring audit
Applications for Class III and AIMD medical devices are required to undergo an Application Audit prior to inclusion of the device(s) on the Australian Register of Therapeutic Goods.
Details on the information required to support an application is set out in the requesting letter sent to the sponsor. There is also a guidance document <http://www.tga.gov.au/docs/html/devguid2.htm> on the documentation requirements.
Despite the detailed information available, TGA's experience has been that sponsors rarely supply all the information required in the first instance, thus delaying applications whilst further requests are sent, or resulting in rejection of the application if a second request is not met. Given that most sponsors have submitted multiple applications over the past four years, it is not clear why the documentation requirements are still not being met.
To assist sponsors in making a complete application, the TGA has undertaken an analysis of submissions requiring audit for the 3 months April-June 2007. This analysis has shown that only 7 of approximately 100 submissions were correct first time, and this has added considerably to the time taken to resolve applications.
The most common deficiencies are (in order of frequency):
- Improperly notarised certificates (16)
- Variants not supplied or invalid (14)
- Most recent QMS audit report not supplied (10)
- Sterilisation validation report not supplied (10)
- Declaration of Conformity not supplied, incorrect or not related to the devices in the application (8)
- Outdated certificates supplied (6)
- GMDN code not correct (6)
- Essential Principles Checklist not supplied or not appropriate (6)
- Evidence of close-out of QMS audit non-conformities not supplied (4)
- Questionable UPI (Unique Product Identifier) (4)
- Design Examination Report not supplied (3)
- Risk Analysis not supplied (3)
- No Clinical Expert report, or no CV for Clinical Expert (3)
- Design Examination Certificate not supplied (2)
- Labelling not supplied (1)
- Documents not supplied in English (1).
The TGA's assessment staff have recently prepared a checklist that sponsors may use to check that the correct documentation has been supplied with the application. This checklist <http://www.tga.gov.au/devices/audit-cklst.htm> is included with the request letter, but may also be downloaded from the website.
Sponsors are urged to ensure that correct documentation is supplied. The time taken to follow-up missing or incorrect documentation is delaying applications unnecessarily, to the extent that the TGA will consider whether future incomplete applications should be rejected without a second request for information.
Assessors have also noted recently an increasing number of applications submitted for Class III devices through DEAL, for which a conformity assessment certificate is required. These applications are not eligible for application audit and will be rejected. These applications include devices containing material of animal origin or substances such as hyaluronan from microbial sources. In all instances an incorrect declaration has been made because "animal/microbial origin" was not checked in the DEAL application. The TGA is concerned that some sponsors do not realise that these components can be of animal/microbial/recombinant origin.