Medical device regulatory engagement meetings

This information is for sponsors and manufacturers of medical devices, including In Vitro Diagnostics (IVDs), who intend to apply:

• to include a device in the Australian Register of Therapeutic Goods (ARTG), or
• for a TGA Conformity Assessment Certificate, or
• for priority applicant determination.

This information does not apply to:

• Manufacturing licence or Good Manufacturing Practice certification or clearance.
• Listed, Prescription, Complementary or Over the Counter Medicines.
• Biologicals (cell and tissue-based products).

Purpose

A medical device regulatory engagement meeting (sometimes known as a pre-submission meeting) is a forum to discuss the regulatory requirements for your medical device, from the beginning during development up to seeking inclusion in the ARTG.

We can help you navigate the regulatory requirements and pathways, discuss the supporting information needed for an application, and identify issues that may arise with your application. 

Please engage with us and reach out early:

• Allow four to six weeks for us to schedule your meeting so we can have the right people there, ready to discuss your concerns.
• You can have more than one meeting.
• We will give you a meeting identifier for you to reference when you submit your application, so the meeting outcome is linked to your application.

At the meeting, we will discuss Australia’s regulatory framework and expectations. We will not co-design your application, technical file, or clinical evidence strategy, and we will not provide detailed commentary or assessment of your data

Types of regulatory engagement meetings

• Scoping – Discussing the development of a medical device, understanding Australia’s regulatory framework and expectations over the device life cycle.
• Application support – Discussing the details of a current application.
• Pre-submission - Discussing specific concerns about an application you are almost ready to submit.
• Regulatory compliance - Discussing compliance issues, such as perceived breaches of the Act
• Strategic - Strategic engagement with the TGA about policy matters, upcoming device innovation pipeline, and other matters.

When meetings are most helpful

We recommend medical device regulatory engagement meetings for:

• Medical devices that meet a selection criterion for application audit – such as those with prior regulatory history.
• Class III medical devices.
• Novel medical devices and new technologies such as Artificial Intelligence.
• Implantable or surgically invasive devices.
• Specific regulatory issues that will likely impact an application.

The meeting process

Before you request a regulatory engagement meeting, please consider what type of meeting you need and the issues you want to discuss. If you have a vaping device or a boundary/ combination product, please read our guidance before seeking a medical device regulatory engagement meeting: 

• We have guidance for Therapeutic Vaping Devices; and
• We have guidance for Combination Products.

To request a meeting, please complete a meeting request form and submit to DevicesRegulatoryEngagement@health.gov.au. 

Note

Allow up to four weeks from initial contact from the regulatory engagement team to actual meeting time. We need at least two weeks to review the briefing pack provided, to plan a productive meeting.

Include sufficient information in the form for us to:

• Determine if a meeting is the best option for your situation.
• Arrange relevant subject matter experts to participate in the meeting.

After we assess the information in the form, we will respond to arrange a videoconference, an in-person meeting at the TGA offices, or a written response. Sometimes meetings are premature, or the issues can be easily resolved without a meeting. 

If a meeting is the best option, we will schedule a mutually acceptable time and date.

Prepare a briefing pack

We will ask you to provide a briefing pack for us to review ahead of the meeting.

Please include:

• an agenda
• a summary of relevant information for the medical device or IVD
• any supplementary information relevant to the meeting
• highlight any questions that you have for us
• summaries describing:
  • results of relevant studies
  • clinical trials with a sufficient degree of quantification
  • any development plan that deviates from current guidelines.
• any issues with the clinical evidence strategy for the medical device 
  (e.g. a surrogate end point, reliance on a single study, a non-inferiority design, adaptive design, etc.).
• any slides or materials you will present at the meeting.

Do not include:

• detailed data or full study and trial reports
• promotional material for the company or the medical device.

Organise the briefing pack content:

• according to the proposed agenda
• number the pages sequentially (sections can be numbered separately)
• include a table of contents, appendices, cross-references and tabs differentiating sections, if necessary
• use the checklist in the meeting request form.

Email the full briefing pack to us at least ten working days before the meeting.

Duration of meeting

We generally allow 1 to 1.5 hours maximum for the meeting. Keep your presentation concise. We will have already reviewed the briefing pack before the meeting but we will not have conducted a formal assessment or review.

Meeting attendees

In the meeting request form, tell us the names, titles and affiliations of everyone you will bring to the meeting, including any consultants. For videoconferences, please provide the email addresses of all attendees. If you need to add attendees, please let us know since you won’t be able to share the meeting invitation.

Rescheduling or cancelling the meeting

If you need to cancel or reschedule, tell us as soon as possible so we can notify participants. We do not generally reschedule or cancel unless there are extenuating circumstances. 

However, we may not proceed with a meeting if the briefing pack:

• arrives too late for us to prepare for the meeting
• contains insufficient information for us to provide meaningful guidance.

Day of the meeting

At the beginning of the meeting the TGA officer will outline:

• housekeeping rules for the meeting
• the purpose of the meeting is to focus only on the issues identified
• the meeting is not to promote the medical device or company history
• You should not record the meeting (but we may use Artificial Intelligence to scribe the meeting)
• we will provide advice based on the briefing pack provided BEFORE the meeting.

Note

if new information is provided during the meeting or as part of the application, the initial advice may vary accordingly.

All participants should summarise the important points, agreements, clarifications and action items.

After the meeting

• Complete a meeting record (use the meeting record form, if desired) of the agreed outcomes and actions.
• Send a copy of the meeting record to TGA within two weeks of the meeting.
• When you submit your application, reference the regulatory engagement meetings you have had. This will help us process your application quickly.
• We value your feedback and strive to continually improve – please complete and return the evaluation form provided in your meeting invitation.
• We aim to acknowledge the meeting record within two weeks of receipt.

Artificial Intelligence

We may record the meeting and use AI scribing to capture the meeting agenda and action items only. We will then destroy the recording. We will give you the opportunity to raise any concerns or to ask us to not use AI scribing. Refer to the published Privacy and security notice for how we manage your information.