In our November newsletter, we published an article outlining the updated Recall Procedures which went live on the 15th of January 2018. The updates include changes to the definitions and descriptions of the recall activities to introduce more flexibility and clarity – including removing some of the confusing terminology and process that previously existed.
TGA also introduced new Recall levels, including “Quarantine” which is set to be a precursor for recall in cases of a serious issues or incidents with a device; it can involve suspension of further supply of a device pending investigation.
The changes have been made to make the process clearer. In the past, there were occasions where end users were confused by the TGA required descriptions of notification and attempted to return r the assumptions by end users could be to return products to the manufacturer when in fact the activity involved field corrections or hazard alerts. This added concern, confusion, and additional strain on manufacturers and sponsors having to handle the associated logistics . The new procedures introduce flow charts which makes the overall process clearer and easier to handle by sponsors – who may have struggled in the past if they’ve not got dedicated regulatory staff.
Plan for a Recall Now
As they say – it’s too late to write the disaster plan the day after the disaster!
All this went live in January. It’s now time to ensure your internal processes are updated to assure continued compliance, and more importantly, supply to market.
Do you have plans in place or processes for communicating with the regulator, the manufacturer, your customers and the media in the event of a recall? Taking action now can reduce some of the fallout in the event you ever need to conduct a recall. And it happens to almost everyone at some time (see here).
Need situation specific advice about your postmarket activities, or just help getting the plans in place? We have extensive experience in implementing recalls on behalf of manufacturers. We work with you to ensure proactive, continuing compliance and manage emerging issues to minimise disruption to your business. Let’s talk! Drop us a line at firstname.lastname@example.org or call our office on +61 2 9906 2984.