TGA survey: regulation of commercial IVDs

The Therapeutic Goods Administration (TGA) invites manufacturers and sponsors of commercially produced in vitro diagnostic medical devices (IVDs) supplied in (or exported from) Australia to take part in a survey about the progress of the transition to the new regulatory framework for IVDs, introduced in 2010 and taking full effect on 1 July 2014.

The survey will provide the TGA with a snapshot of progress in the remainder of the transition period, including an estimation of the number and type of IVD applications the TGA should expect in the lead-up to 1 July 2014. The TGA will use the survey results to plan for increases in the volume of applications and effective future communication with industry on IVD regulatory matters.

The survey is in addition to the TGA’s recent public consultation on proposed amendments to the new regulatory framework for IVDs.

Depending on your answers, the survey will take approximately 15-20 minutes to complete. It can be completed in more than one session and will remain open until the close of business on Monday 22 July 2013.

Instructions for completing the survey, and information to assist your answers, are available here.