What to do when the TGA comes knocking: the TGA's investigation powers

The email hits your inbox: the Therapeutic Goods Administration (TGA) has issued a notice requiring the production of information and documents relating to the safety and efficacy of your medical device. The TGA has serious concerns that may result in suspension or cancellation of the device from the Australian Register of Therapeutic Goods (ARTG). The clock starts. What now?

This is the first article in a series examining the processes for suspending or cancelling medical devices from the ARTG.

This article will explain the TGA’s investigation powers that can be exercised in relation to medical devices and how sponsors can cooperate effectively. In our next article, we will look at what to do when the TGA issues a proposal to suspend or cancel a medical device. Finally, our third article in this series will explore avenues of review that are available if the TGA proceeds to suspend or cancel the device.

This article sets out the TGA's key investigative and information-gathering powers, and provides practical guidance on how sponsors should best prepare and respond. How you respond may determine whether the matter resolves cooperatively or escalates to suspension or cancellation of the device from the ARTG.

Why the TGA knocks

Following inclusion in the ARTG, the TGA engages in extensive post-market monitoring, surveillance and investigation of medical devices to ensure that devices continue to be safe and effective. All classes of medical devices, including Class I (non-sterile, non-measuring) devices, are subject to the TGA’s post-market powers.

The TGA will open an investigation where trends or signals are identified from:

• adverse event reports received by the TGA
• mandatory information provided by sponsors, including information relating to compliance with Essential Principles and changes to reliance certificates or other documents
• literature reviews of the available clinical evidence
• actions taken by overseas regulators. The issuance of alerts, restrictions or device recalls by comparable overseas regulators, particularly the Food and Drug Administration (FDA) in the United States, often leads to the exercise of investigatory and information-gathering powers
• safety or performance issues that have affected similar devices, and/or
• circumstances where a device has been the subject of a recall

The TGA's information-gathering powers

The TGA often starts with informal enquiries, such as questionnaires or follow‑ups to device incident reports. These are ordinarily informal, voluntary requests, however, it is important to handle them carefully.

If the TGA has serious concerns, or if the information that is provided voluntarily is not sufficient, compulsory notices under section 41JA of the Therapeutic Goods Act 1989 (Cth) (TG Act) will be issued.

Section 41JA empowers the TGA, by written notice, to require a party to provide information or documents relating to a medical device (41JA Notice). The power can be exercised in relation to a wide range of parties, including:

• applicants for inclusion of a device in the ARTG
• applicants for a Conformity Assessment Certificate (CA Certificate)
• sponsors
• current holders of a CA Certificate or Australian Conformity Assessment Body Certificate (ACAB Certificate), or
• former holders of CA Certificates or ACAB Certificates, or former sponsors during the relevant notice period, being either 5 or 10 years prior.

The TGA also has the power under section 45AB of the TG Act to require the production of information or documents by any person relevant to a contravention or possible contravention of the TG Act or regulations (45AB Notice). While the TGA’s powers under section 45AB are broad and information obtained under a 45AB Notice may reveal or confirm grounds for suspension or cancellation, the TGA will ordinarily rely on a 41JA Notice if it is investigating concerns about the safety or efficacy of a device (or compliance with the Essential Principles and Conformity Assessment procedures) that may be relevant to a decision to suspend or cancel an ARTG registration.

The scope of the information that may be sought under a 41JA Notice is wide. The TGA may request information or documents relevant to one or more of the following matters:

• whether the medical device complies with the Essential Principles
• whether Conformity Assessment procedures (or comparable requirements) have been applied to the devices
• whether conditions of a CA Certificate or conditions of inclusion in the ARTG have been complied with
• whether advertising requirements under the TG Act and Therapeutic Goods Advertising Code have been met
• whether the medical device is being supplied in, imported into, or exported from Australia
• the safety and efficacy of the devices for their intended purposes
• the regulatory history of the devices in another country
• matters relating to any malfunctions or performance deterioration or inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the devices
• the accuracy of information included in or with an application, and
• whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information to substantiate compliance with the Essential Principles and the application of Conformity Assessment procedures.

Recipients of a 41JA Notice must provide the requested information within the timeframe stated in the notice (which must not be less than 10 working days). Applications for extensions of time can be made, however, this is a matter of discretion. Finally, the TGA may issue successive section 41JA Notices if additional information is required.

After receiving information and documents, the TGA will usually conduct technical assessments, which may include review by the Advisory Committee on Medical Devices (ACMD), engineering analysis and clinical review, with the aim of assessing whether further regulatory action is necessary. The ACMD is an independent expert committee that provides the TGA with medical and scientific advice on the safety, performance and manufacture of medical devices supplied in Australia, including issues relating to pre-market Conformity Assessment and post-market monitoring.

Consequences of non-compliance

The consequences of failing to comply with a 41JA Notice are significant.

• Penalties for non-compliance: Failure to comply may be a criminal offence, carrying a maximum penalty of A$825,000 for a body corporate.
• Regulatory consequences for non-compliance: Failure to comply may also lead to suspension or cancellation of the ARTG entry for the medical device.
• Penalties for false or misleading information: Providing false or misleading information in response to a 41JA Notice also carries serious penalties, including a civil penalty of up to A$16,500,000 for a body corporate, or conviction of a criminal offence which carries a maximum penalty of imprisonment for 5 years or up to A$6,600,000 for a body corporate, or both.

Get your house in order: practical guidance

1. Take the notice seriously and act quickly: Escalate the notice to internal and external legal advisers to fast-track the strategy for the response.
2. Map data sources and owners: Identify each repository and system that may hold responsive material, for example, complaints databases, Corrective and Preventive Action (CAPA) Plan records, Post-Market Clinical Follow-Up (PMCF) reports, Periodic Safety Update Reports (PSURs) and manufacturing records. For each source, identify where the data is held, access restrictions, and practical steps that will be required to extract information.
3. Engage the manufacturer early: Overseas manufacturers will often hold key technical files. Sponsors should ensure they have contractual rights to obtain information and documents from manufacturers within at least 20 working days, and ideally within 10 working days.
4. Be accurate and complete: Given the significant penalties that may apply if information provided to the TGA is false or misleading, and the risk of further regulatory action if the response is incomplete, responses should be carefully considered for accuracy and completeness by all stakeholders and advisers.
5. Seek an extension early: If more time is required, approach the TGA well before the deadline with clear reasons for the need for additional time, steps that have already been taken to comply, and a date by which a complete response can be provided. Any extension will be a matter of the TGA’s discretion, and sponsors should not assume that requests will be granted.
6. Keep records of all communications: Maintain a clear and comprehensive record of all substantive communications with the TGA, including letters, emails and file notes of meetings, as these may become important if the matter progresses to a proposal to suspend or cancel.
7. Handling trade secrets and clinical data: Where submissions contain proprietary manufacturing information, clinical data or other commercially sensitive material, label those parts “Confidential—commercial‑in‑confidence” and request that the information be treated confidentially. In some circumstances, it may be appropriate to include language relating to FOI requests that may be made by third parties, which could catch confidential information in correspondence with the TGA.

Concluding remarks

It is important to remember that receiving an investigation notice from the TGA does not necessarily lead to a proposal to suspend or cancel an ARTG entry. Many investigations are resolved at the information-gathering stage, particularly where sponsors provide well‑organised evidence and commit to actions that mitigate risk.

However, if the TGA is satisfied that information it has gathered supports a ground of suspension or cancellation, the next step will likely be a proposal to suspend or cancel the ARTG entry for a medical device. In our next article in this series, we will look at what to do if the TGA knocks again and issues a proposal to suspend or cancel a medical device.