Medical Device Vigilance Reporting for Australia TGA Compliance

As in other jurisdictions, the Therapeutic Goods Administration (TGA) has established several requirements related to medical device vigilance reporting in Australia, included in the Australian Register of Therapeutic Goods (ARTG). These cover the reporting of adverse events, communication with the TGA for recall and non-recall actions, and (for certain devices) annual reporting obligations that apply for the first few years’ post-registration.

Medical device vigilance reporting requirements in Australia

In this article, we provide an overview of each of these TGA Australian vigilance reporting requirements. 

Adverse event reporting

One of the conditions for the inclusion of devices on the ARTG is that sponsors of medical devices report ‘adverse events’ or ‘near adverse events’ to the TGA Incident Reporting and Investigation Scheme (IRIS). 

An ‘adverse event’ is an occurrence involving a medical device that meets the following criteria: 

• • Death of a patient, health care provider, user, or other person;
  • A serious injury or serious deterioration to a patient, health care provider, user, or other person, including; 
    • Life-threatening illness or injury; 
    • Permanent impairment of a body function; 
    • Permanent damage to a body structure; or 
    • A condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure. 

A ‘near adverse event’ is an occurrence involving a medical device that might have led to a death or serious injury if, for example, the timely intervention of a healthcare practitioner is the only reason a death or serious injury did not occur. For an event to be defined as a near-adverse event, it is sufficient that: 

• • An event associated with the device occurred;
  • If the event occurred again, it might lead to death or serious injury as outlined above. 

Only adverse events and near adverse events that occur in Australia must be reported to the TGA. While adverse events or near adverse events that occur overseas for devices supplied in Australia do not need to be reported, records of these events must be available if requested by the TGA, and any remedial action (e.g. recall or field safety corrective action) that is performed overseas for devices supplied in Australia must be reported to the TGA Recalls team. 

There are several exemptions to reporting which are aligned with the exemptions under the EU regulatory framework (e.g. Deficiency of a new device found by the user before its use), these exemption rules are not applicable when: 

• • A device, event, or issue specifically identified by the TGA as an issue that requires close monitoring – sponsors of devices that are affected will be notified by the TGA when this occurs 
  • An adverse event is normally subject to a reporting exemption, where a change in trend (usually an increase in frequency) or pattern is identified 
  • Adverse events associated with user error, as the TGA may use this data to identify trends with similar products that may lead to recommendations for: 
    • Corrective action for the device 
    • Revising the labelling or Instructions for Use 
    • Identifying a need for increased user education. 

Initial reports must be submitted by Australian Sponsors within the following timeframes established in the Therapeutic Goods (Medical Devices) Regulations 2002: 

Initial timeframe for medical device vigilance reporting in Australia

While the TGA acknowledges that root cause investigation takes time, sponsors must provide the TGA with follow-up reports at regulator intervals and no less than every 30 calendar days up to the final report which is due within 120 calendar days of initial report submission. 

An important consideration of the final report is that it must include information about ‘similar events’ that have occurred over the previous three years, as the TGA believes this information allows it to develop a clearer understanding of the incidence of the reported event within and outside of Australia. 

Information on reported adverse events and near adverse events, is publicly available in the TGA’s Database of Adverse Events Notifications (DAEN) – Medical Devices. 

Recall and non-recall actions 

The TGA’s expectations and requirements for the communication and realization of recall and non-recall actions are established in the Uniform Recall Procedure for Therapeutic Goods (URPTG), currently in V2.3 as of the date of this article. The TGA has also made available several templates related to this procedure readily available on its website here, particularly relevant for customer communication. 

The following types of recall and non-recall actions, defined in the URPTG, must be communicated and approved by the TGA before their realization: 

Manufacturers of software-based medical devices, particularly standalone medical device software (also referred to as Software as a Medical Device (SaMD)) should be cautious with any in-software notifications launched as they could fall within the scope of non-recall actions requiring communication to the TGA and its approval before their launch. 

Information on recall actions undertaken in Australia is publicly available in the TGA’s System for Australian Recall Actions (SARA) database. 

Annual reporting

Annual reporting is a mandatory requirement over the first three consecutive years following ARTG entry for the following types of devices: 

• • Implantable Class IIb 
  • Class III 
  • Active Implantable Medical Device (AIMD) 
  • Class 4 IVD 

These annual reports should cover the period from 1 July to 30 June (Australian financial year period) and must be submitted by Australian Sponsors by 1 October each year. Depending upon the date of initial ARTG entry, the first report should be for a period covering at least six months, but not longer than 18 months. 

These annual reports must include the following information: 

• • ARTG number 
  • Product name(s) 
  • Model number(s) 
  • Number of devices supplied in Australia by product/model 
  • Number of devices supplied worldwide (numbers should include devices that are the same but supplied under a different name in another jurisdiction) by product/model 
  • Number of complaints in Australia by product/model 
  • Number of complaints by product/model 
  • Number of adverse events and incident rates in Australia (Rate = No. of events/No. Supplied x 100 = Rate %) 
  • Number of adverse events and incident rates worldwide 
  • A list of all complaints and adverse events identifying the jurisdiction where the complaint or adverse event originated 
  • Device Incident Report (DIR) number of those adverse events reported to the TGA 
  • Details of any regulatory/corrective action/notification by the manufacturer 

Learn more about medical device vigilance reporting requirements in Australia

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Additional resources

• • Australian TGA Sponsor
  • Australian Medical Device Approval: CE Certification and Alternative Pathways