Author: Homi Dalal
Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to a patient or device users or others.
Manufacturers are aware that adverse events can trigger a post-market review by the Therapeutic Good Administration (TGA). These reviews help determine if the device continues to meet safety and performance requirements and to ensure the sponsor is in compliance with the conditions of ARTG Inclusion.
TGA reviews may result in several outcomes:
- improvements to the supporting documentation;
- a need for design change; or
- suspension or cancellation of the device from the ARTG.
Any of these can also trigger post-market action, including safety alerts or device recalls. Following the increase in post-market surveillance, it is critically important that all manufacturers, sponsors and distributors are fully aware of their obligations under the Act.
Effective Monday, 19 October 2020, the TGA deployed a new Post Market Review Compliance Dashboard, developed to improve accessibility and capability in the post-market monitoring of medical devices.
The dashboard, accessed through eBS, allows sponsors to view and respond to notifications efficiently and securely using a central location. Sponsors may upload relevant files (up to 15GB per file), without the need to send files via the Cloud, email, or mailing USBs to different teams at the TGA.
To assist sponsors with proper usage of the dashboard in responding to notifications (including requests for information, proposals to cancel or suspend notifications, or on conditions of inclusion) TGA has made available a Reference Guide providing step-by-step instructions. In addition, webinars providing further guidance in training sessions were also held during October 2020.
In June 2020, besides developing demonstrations and training guidelines in preparation for implementation, the TGA sought participation from select sponsors to test the functionality and ease of use of the dashboard and provide feedback. Brandwood CKC participated in this testing and validation and found the dashboard to be very user-friendly.
Our consultants are well versed in post-market compliance requirements based on their local experience and knowledge – please reach out to our regulatory experts to provide assistance and support in all your post-market activities.