The core objective of post-market monitoring and vigilance is to enhance the well-being and safety of patients, healthcare professionals, users, and others by minimizing the occurrence of adverse events.
The monitoring of post-market performance aims to identify trends or issues that were previously undisclosed.
In Australia, manufacturers hold the responsibility to thoroughly investigate, implement adequate risk management protocols, and undertake necessary corrective and preventive measures regarding their medical devices, and following their conformity assessment procedures. Nevertheless, sponsors are obligated to report such incidents to the Therapeutic Goods Administration (TGA).
Sponsors of medical devices are mandated by the Therapeutic Goods (Medical Devices) Regulations 2002, specifically under 5.7, to report any adverse events or near adverse events to the TGA Incident Reporting and Investigation Scheme (IRIS).
- Devices may be the subject of post-market examinations or inquiries at any moment.
- Devices are subject to inclusion requirements like annual reports for more advanced device classes.
Sponsors are able to submit the reports through the TGA eBusiness Portal.
These reports enable the TGA to assess the manufacturer's actions and, if necessary, enforce suitable Regulatory measures to address the issues, consequently mitigating risks and minimizing the impact on the public.
When adverse events and complaints occur, they are reported to the TGA and recorded in a database. The TGA or an advisory panel reviews this data, which can lead to actions such as recalling products, adjusts market approvals, mandates user education, conducts inspections, and continues monitoring for trends.
For higher risk devices like AIMD, Class III, or implanted Class IIb devices, sponsors are required to submit three (03) consecutive annual reports to the TGA. All complaints about issues regarding the use of the product that the maker has been made aware of must be included in the reports.
Sponsors Timeframes for Reporting to the TGA –
Adverse Events: Sponsors are required to provide information on incidents involving their products that have caused significant injury or death, or that have the potential to do so.
- Within fourty eight (48) hours of learning about a substantial harm to the public's health that calls
for immediate action to lessen the risk.
- Within ten (10) days of becoming aware of a death or severe injury.
- Within thirty (30) days of becoming aware of an incident that could potentially result in serious injury or death.
Exemptions from Reporting –
Exemption rules from reporting adverse events to the TGA-
- Discovery of a device's deficiency by the user before using it.
- Adverse event solely attributed to patient conditions.
- Lifespan of the medical device.
- Successful functioning of protection against a fault.
- Remote possibility of death or serious injury occurrence.
- Anticipated and predictable side effects documented in the manufacturer's Instructions for Use (IFU) or labeling.
- Adverse events outlined in an advisory notice.
- Exemptions from reporting granted by the TGA.
How to Report an Adverse Event?
Sponsors of medical devices included in the ARTG are strongly encouraged to submit reportable adverse events electronically through the Medical Device Incident Reporting (MDIR) application present within the TGA TBS portal.
Through the reporting of adverse events, the TGA can actively observe the real-world usage and performance of medical devices, identifying any emerging safety or performance concerns indicated by trends.
Embracing technological advancements and integrating PMS into the product lifecycle will further enhance the ability to detect and respond to emerging trends and ensure the highest standards of safety and effectiveness. To be updated on the new safety and reporting requirements being introduced on a regular basis, reach out to our Regulatory partner who can help in navigating the Regulatory landscape with compliance. Stay informed. Stay compliant.