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TGA PMS and Vigilance Requirements for Medical Devices.

TGA PMS and Vigilance Requirements for Medical Devices

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Australian TGA Sponsor

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As the Therapeutic Goods Administration (TGA) is a founding member of the International Medical Device Regulators Forum (IMDRF), the Australian medical device regulatory framework is largely aligned with IMDRF guidance. However, it is important to note that there are several TGA specific post-market surveillance (PMS) and vigilance requirements established in Australia under the conditions of inclusion on the Australian Register of Therapeutic Goods (ARTG) and under conformity assessment procedures. It is critical that manufacturers seeking to enter this market are aware of these obligations under the TGA regulatory framework. In this article, we provide an overview of the Australian PMS and vigilance requirements, as well as information on the public vigilance data made available by the TGA. 

TGA PMS and Vigilance Requirements Overview

Regulation 4.2(a) of the Therapeutic Goods (Medical Devices) Regulations 2002 establishes that manufacturers, under applicable conformity assessment procedures, must establish and maintain a post-market monitoring, reporting, and corrective action system. All conformity assessment procedures established under this regulation require such a system. 

In contrast to the EU MDR/IVDR, Australian regulations do not include specific requirements for the content of documentation generated for PMS across all devices. Therefore, PMS documentation prepared to comply with the EU MDR/IVDR can serve as a basis for compliance with TGA PMS requirements. 

Annual Reporting Requirements

While Periodic Safety Update Reports (PSURs), as required under the EU MDR/IVDR, are not mandated in Australia, certain devices are subject to annual reporting requirements. These requirements can be integrated into a manufacturer’s broader PMS processes. 

Australian sponsors of the following medical devices must submit three consecutive annual reports to the TGA after the device is included in the ARTG: 

  • Class III devices 
  • Implantable Class IIb devices 
  • Class 4 in vitro diagnostic (IVD) medical devices 

These annual reports are due to the TGA on October 1 each year and must cover the period from July 1 to June 30, aligning with the Australian financial year. The first report must cover at least six months but no more than 18 months. 

Manufacturers should be mindful of these deadlines, as the TGA does not issue reminders. Failure to submit reports on time may result in cancellation of ARTG inclusion. While submission is the sponsor’s obligation, they rely on manufacturers for the required data, which includes (but is not limited to): 

  • Number of devices supplied in Australia and globally, by product/model 
  • Number of complaints in Australia and globally, by product/model 
  • Number of adverse events and incident rates, in Australia and globally 
  • List of all complaints and adverse events with jurisdiction of origin 
  • Details of regulatory/corrective actions, including any Device Incident Report (DIR) numbers 

The TGA provides a report template but will only contact the sponsor for clarification or further information if needed. 

Adverse Event Reporting 

A condition of ARTG inclusion is that sponsors must report adverse or near-adverse events to the TGA, defined as follows: 

  • Adverse Event: An event that led to: 
    • Death 
    • Serious injury or deterioration, including: 
      • Life-threatening illness or injury 
      • Permanent impairment of a body function 
      • Permanent damage to a body structure 
      • A condition requiring medical or surgical intervention to prevent the above 
  • Near Adverse Event: An event that might have led to death or serious injury. This includes cases where timely intervention prevented serious outcomes. An event qualifies as a near adverse event if: 
    • It occurred in association with the device 
    • If repeated, it could result in serious injury or death 

Reporting Exemptions 

There are eight exemption rules for reporting events to the TGA. Sponsors/manufacturers must document justification for using these exemptions: 

  1. Device deficiency detected before use 
  1. Event solely caused by patient condition 
  1. Event occurs after the expected service life 
  1. Device’s built-in protection worked as intended 
  1. Extremely unlikely to cause serious injury or death 
  1. Expected side effects listed in the IFU/labelling 
  1. Events described in an advisory notice 
  1. Reporting exemptions granted by the TGA 

However, exemptions do not apply when: 

  • The TGA identifies a device or issue that requires close monitoring 
  • There is a trend or pattern change (e.g. increased frequency) 
  • User error is involved, as TGA may use this data to recommend: 
    • Device corrections 
    • Revisions to IFU/labelling 
    • Enhanced user training 

Adverse Event Reporting Process 

Reports are submitted electronically via the Medical Device Incident Reporting (MDIR) system. 

  • Initial Report Timelines: 
    • Where the event represents a serious threat to public health, it should be reported 48 hours after becoming aware of the event or occurrence 
    • Where the event leads to death or a serious deterioration in the state of health, of a patient, a user of the device, or another person, it should be reported 10 days after becoming aware of the event or occurrence 
    • Where an event, occurrence or recurrence which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person, it should be reported 30 days after becoming aware of the event or occurrence 
  • Follow-Up Reports: 
    • Information regarding the status of any internal manufacturing investigation is expected to be shared with the TGA at regular intervals, and no less than every 30 calendar days. This also includes the provision of any additional information that was unavailable during submission of the initial report. 
  • Final Report: 
    • Sponsors must submit a final report within 120 calendar days of the submission of an initial report at which point in time the TGA expects that manufacturers have had sufficient time to complete a detailed investigation of the reported event and identifying any relevant root causes and corrective actions taken. The final report must also include information about ‘similar events’ for which similar events over the previous three years must be described. 

It should also be noted that in contrast to other jurisdictions that require manufacturers to determine the appropriate IMDRF adverse code / term to be applied to an adverse event / near adverse event, the TGA performs this for all such reported events. 

All adverse event reports are submitted by sponsors to the TGA electronically through the Medical Device Incident Reporting (MDIR) application, with guidance provided by the regulator. 

Given these annual reporting obligations, it’s clear that a strong understanding of TGA PMS and Vigilance processes is essential for maintaining ARTG inclusion.

Procedure for Recalls, Product Alerts and Product Corrections 

On March 5, 2025, PRAC took effect in Australia, replacing the previous Uniform Recall Procedure for Therapeutic Goods (URPTG). The transition from the URPTG to the PRAC doesn’t make significant changes to the process for sponsors performing recalls, product alerts and product corrections, however it does greatly facilitate the readability of the requirements (e.g. removing references to ‘recall’ and ‘non-recall’ actions which previously confused many manufacturers / sponsors and use of the term ‘market actions’). 

The purpose of the PRAC is to still provide guidance to sponsors on performing market actions to address problems with a therapeutic good that may pose a risk to public health and safety, which in the case of medical devices includes problems with: 

  • Safety 
  • Quality 
  • Performance 
  • Presentation 
  • Product use 

Under the PRAC, the TGA directs sponsors to immediately instruct its customers to quarantine affects goods, confirm that customers have notified impacted surgeons or clinicians (where applicable) as well as other areas who may have received the goods, prior to contacting the TGA for instructions when such problems relate to: 

  • Imminent and significant risk risks to patient lives or public health 
  • Actual or suspected tampering 
  • Radiopharnaceuticals 
  • Blood or blood components 
  • Biological or human tissue 
  • Clinical trials 

Where sponsors are unsure as to whether immediate action is necessary (e.g. if there could be a shortage or disruption to critical patient care), the TGA encourages sponsors to contact the regulator as soon as possible. 

Beyond these circumstances which require immediate action by the sponsor, the five steps to taking appropriate market action include the following, for which guidance is provided under the: 

  1. Problem assessment 

This requires an assessment, typically performed by the sponsor together with the manufacturer when assesses the details of the impacted goods, a risk analysis (performed by the manufacturer), and identification of any commercially sensitive information to be included in the notification. 

  1. Preparation and submission of the notification to the TGA 

Notifications are submitted to the TGA online by sponsors through the TGA eBusiness Services portal and must include the following documents: 

  • Risk assessment (indicating the root case, probability and severity of harm) 
  • Customer list (State, Customer Name, Suburb) 
  • Customer Letter (for which templates are available from the TGA) 
  • Customer Response Form (for which templates are available from the TGA) 
  • Additional documentation, as necessary (e.g. Public Notice where sponsors or their suppliers are unable to identify all end users) 

Additionally, sponsors can propose the market action class, type and level in the notification from the following options: 

  • Class 
    • Class I – Critical safety-related, where the problem presents a reasonable possibility of serious injury or death 
    • Class II – Urgent safety-related, where the problem presents a reasonable possibility of temporary or minor injury, and/or the likelihood of serious injury or death is remote 
    • Class III – Lowest risk, where the problem is not likely to lead to injury, and/or chance of a temporary or minor injury is remote 
  • Type 
    • Recall (i.e. return/disposal of the product) 
    • Product correction (i.e. Correct/Fix the product) 
    • Product alert (i.e. Raise awareness about deficiencies, potential deficiencies, or other concerns with use of a product) 
    • Quarantine (i.e. Avoid use of supply of the product, pending further advice) 
  • Level 
    • Wholesale 
    • Hospital 
    • Retail 
    • Consumer 
  1. TGA’s review of the submission 

The TGA assesses whether the proposed action and timeline, in its opinion, effectively mitigate(s) the risk(s) and any impact the action and timeline could have on the supply of critical goods. 

Following its review, the TGA will send an agreement letter to the sponsor with any edits to customer letter(s)/notice(s) it deems necessary, which are considered to be the TGA-approved versions. Where the sponsor does not agree with the edits made, it must contact the TGA immediately for discussion. 

  1. Initiation of the market action 

Upon receipt of the TGA’s agreement letter, the sponsor is required to accept all edits to the approved customer letter, sign it, and return it to the TGA before 11am AEDT / AEDT the following business day, at which point the sponsor may begin distributing the TGA-approved, signed copy of the customer letter to all impacts customers. 

The TGA does allow for the collection of customer responses from a range of sources but does expect sponsors to follow-up with customers at least three times (exclusive of the original contact attempt) to obtain a response via different methods. 

  1. Finalization of the market action 

The TGA does require periodic updates on the progress of the market action taken, prepared using the reporting templates included in the agreement letter, typically at 6 weeks (interim) and 12 weeks (closeout) after the action has been initiated (although other reporting timeframes can be agreed with the TGA). Should additional time me necessary to complete the market action, a valid reason will need to be provided to the TGA, with further reports to be provided at a frequency determined by the TGA. 

Care does need to be taken regarding notification of the appropriate ‘lead regulator’ in Australia. For example, where medical devices are also consumer goods and the actions involve non-compliance with a safety standard (e.g. Mandatory Standard for products containing Button and Coin Batteries) or ban, the Australian Competition and Consumer Commission (ACCC) rather than the TGA will be the ‘lead regulator’ who should be notified.[1],[2] 

Additionally, for medical devices which are also consumer goods, within 10 days of agreement, the sponsor must notify the Australian Government Minister for consumer safety, where there has been overseas supply, and the ACCC must be notified of all market actions taken within two days of receiving a TGA agreement letter where the medical device is also a consumer good. 

TGA Public Vigilance Data 

There are two separate publicly accessible databases maintained by the TGA with vigilance data: 

  • Database of Adverse Event Notifications (DAEN) – Medical devices. This database (which does not include reported adverse events from the last three months prior to the search date) contains all adverse events for medical devices received by the TGA since July 1, 2012, including those reported by manufacturers / sponsors as well as healthcare professionals / user facilities. 
  • Database of Recalls, Product Alerts and Product Corrections (DRAC). This database contains data on all recalls, product alerts and product corrections performed since July 1, 2012 in Australia and is updated with actions taken two days after the decision between the responsible entity and the TGA to initiate the action. Where there is a need to alert the public (e.g. consumer level actions, public health threats), the TGA also publishes notices on its Alerts page. 

These resources may be used by manufacturers as part of the risk management, clinical/performance evaluation, and PMS processes to identify relevant vigilance data for equivalent/similar devices by the TGA.

Learn more about TGA PMS and Vigilance Requirements with MedEnvoy 

This article provides an overview of TGA’s PMS and vigilance requirements in Australia. MedEnvoy’s regulatory experts can assist manufacturers in staying compliant with the latest TGA requirements. Furthermore, MedEnvoy has offices in Australia providing Australian Sponsor services. Please reach out should you need assistance by clicking here and for information about our regulatory experts click here. 

[1] ACCC Mandatory Product Safety Standards: https://www.productsafety.gov.au/business/search-mandatory-standards 

[2] ACCC Banned Products: https://www.productsafety.gov.au/business/find-banned-products 

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