Medical Device Regulatory Engagement Meetings – TGA Pre-Submission Process

Purpose and Benefits

Regulatory engagement meetings provide an opportunity for sponsors to discuss their medical device with the TGA before submitting a formal application. These meetings aim to:

• Clarify TGA expectations and regulatory pathways.
• Identify potential issues early in the development or application process.
• Align on evidence requirements, classification, and conformity assessment routes.
• Improve submission quality and reduce the likelihood of major objections during review.

Meetings are particularly valuable for novel, high-risk, or complex devices where regulatory requirements may be unclear or innovative approaches are proposed. Source: Medical device regulatory engagement meetings - TGA

Types of Meetings Available

The TGA offers several categories of pre-submission meetings:

• Pre-submission meetings – General discussions on regulatory strategy, classification, intended purpose, or evidence planning.
• Pre-approval meetings – Focused on specific aspects of an impending conformity assessment or ARTG inclusion application.
• Innovation pathway meetings – For breakthrough or novel devices, often involving early engagement on clinical evidence or novel technologies.

Meeting format may be face-to-face, videoconference, or teleconference, depending on circumstances.

Eligibility and Prioritisation

Meetings are available to sponsors intending to submit applications for:

• Higher classification devices (Class IIb, III, AIMD).
• Devices with novel technology or intended use.
• Complex regulatory pathways or borderline classifications.
• Significant changes to existing ARTG entries.

TGA prioritises meetings based on public health need, innovation level, and complexity. Not all requests are granted; TGA assesses each on a case-by-case basis.

Requesting a Meeting

To request a meeting:

• Submit a formal request via the TGA eBusiness Services portal or email.
• Provide a detailed briefing package including:
  • Device description and intended purpose.
  • Proposed classification and regulatory pathway.
  • Key questions or issues for discussion.
  • Summary of development status and evidence available.
• TGA typically responds within 10 working days to confirm acceptance, suggest alternative options, or decline with reasons.

Accepted meetings are scheduled within 4–8 weeks, depending on priority and availability.

Meeting Preparation and Conduct

• Sponsors should prepare clear, focused questions and supporting materials.
• TGA representatives (technical experts, reviewers) attend to provide guidance.
• Meetings are non-binding; TGA advice is based on information provided and does not constitute formal approval.
• Minutes are recorded and provided to the sponsor for reference.

Post-Meeting Expectations

• Sponsors are encouraged to incorporate TGA feedback into their development and submission strategy.
• Meeting outcomes do not guarantee application acceptance; full assessment occurs during formal review.
• Significant new information after the meeting may require follow-up engagement.

Detailed guidance on meeting types, request templates, briefing package requirements, prioritisation criteria, and examples of suitable questions is available in the official TGA page on medical device regulatory engagement meetings. Source: Medical device regulatory engagement meetings - TGA

These meetings enhance regulatory predictability and support efficient market access for innovative and complex medical devices in Australia.