On October 10, 2023, the TGA announced the start of its medical devices vigilance program pilot. We look at the key aspects of TGA vigilance framework for medical devices and the 12-month voluntary pilot program.

By Val Theisz

Australia has a post-market surveillance framework for therapeutic products. For medical devices, the manufacturers’ post-market responsibilities are specified in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Following the 2020 TGA consultation: ‘Proposed enhancements to adverse event reporting for medical devices‘, the TGA developed the Medical Devices Vigilance Program (MDVP), an initiative aimed at improving sponsors’ understanding of, and compliance with, their post-market obligations through a self-assessment tool (SAT) and program of desktop audits (DAT) and on-site inspections.

The legislative and regulatory provisions reviewed by the MDVP are those defining the conditions for inclusion in the Australian Register Therapeutic Goods (ARTG) and listed below.

Therapeutic Goods Act 1989

• 41FN Conditions applying automatically
• 41KA Public notification, and recall, of medical devices [by the Secretary of the Department of Health]
• 41MP Criminal offence for failing to notify adverse events etc.
• 41MPA Civil penalty for failing to notify adverse events etc.

Therapeutic Goods (Medical Devices) Regulation 2002

• §5.7 Conditions applying automatically – period for giving information about adverse events etc (Act s 41FN)
• §5.8 Conditions applying automatically – requirements in relation to information about kind of medical device (Act s 41FN)
• §5.8A Conditions applying automatically in relation to providing reports about adverse events or occurrences (Act s 41FN)
• §5.10 Conditions applying automatically – record‑keeping (Act s 41FN)
• §5.11 Conditions applying automatically—reporting for Class IIb implantable, Class III, and Class 4IVD medical devices (Act s 41FN)
• §8.1 Notice period for information or documents requested by the Secretary in relation to manufacturing records (5 years) and distribution records (10 years for Class IIb implantable and Class III devices; 5 years for other devices)

The key to compliance is to generate accurate records in a timely manner and maintain those records so that they can be easily retrieved upon request. Documentation and records required include:

• Information substantiating compliance with the essential principles of safety and performance (EPs) and conformity assessment procedures (CAPs)
• Records of complaints and adverse events, including reporting
• Records of recall actions, follow-ups, and notifications
• Product supply and distribution records
• Annual reporting for Class IIb implantable, III and 4 IVD devices

The MDVP Pilot program will run for 12 months, and it represents an excellent opportunity for Australian manufacturers and sponsors to test their existing capabilities and improve their organisations’ compliance with the statutory requirements. Participation is voluntary; all Australian medical device sponsors who have an entry in the ARTG are eligible to participate in the MDVP Pilot.

Details on how to participate in the MDVP Pilot can be found on TGA’s website: Medical Devices Vigilance Program – Pilot

Further information on post-market obligations: Post market responsibilities for manufacturers and sponsors of medical devices