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January 16, 2026
Approximately 5 minutes
Pre-Submission Regulatory Engagement Meetings for Medical Devices – TGA Guidance
Pre-Submission Regulatory Engagement Meetings for Medical Devices – TGA Guidance
Purpose and Objectives
Pre-submission regulatory engagement meetings allow sponsors to discuss their medical device with TGA experts before lodging a formal application. The main goals are to:
- Clarify regulatory classification, intended purpose, and applicable conformity assessment routes.
- Discuss the evidence required to demonstrate compliance with Essential Principles.
- Identify potential regulatory challenges or data gaps early.
- Align expectations on application format, content, and review timelines.
- Improve the quality of submissions and facilitate more efficient TGA assessment.
These meetings are especially useful for innovative technologies, higher-class devices (Class IIb, III, AIMD), borderline products, or novel regulatory pathways. Source: Medical device regulatory engagement meetings - TGA
Types of Pre-Submission Meetings
The TGA offers different meeting categories depending on the stage and complexity:
- General pre-submission meetings: Broad discussions on regulatory strategy, classification, or evidence planning.
- Targeted pre-submission meetings: Focused on specific aspects (e.g., clinical evidence, software as medical device, combination products).
- Innovation pathway meetings: For breakthrough or novel devices, often involving early advice on clinical development or novel conformity approaches.
Meetings can be held via videoconference, teleconference, or in-person (where feasible).
Eligibility and Request Process
Meetings are prioritised for:
- Higher-risk or novel devices.
- Applications likely to involve complex regulatory issues.
- Sponsors seeking clarity on Australian-specific requirements.
To request a meeting:
- Submit a request through the TGA Business Services portal.
- Provide a briefing document including device description, intended purpose, proposed classification, key questions, and development status.
- TGA assesses requests and typically responds within 10 working days to confirm acceptance, propose alternatives, or explain declination.
Accepted meetings are scheduled within 4–8 weeks, depending on priority and availability.
Preparation and Conduct
Sponsors should:
- Prepare focused questions and supporting materials (e.g., draft intended purpose, classification rationale, evidence outline).
- Limit attendance to key personnel.
- Submit briefing package at least 10 working days before the meeting.
TGA participants include relevant technical experts. Discussions are advisory and non-binding; minutes are provided to the sponsor post-meeting.
Post-Meeting Actions and Limitations
- TGA feedback should be considered in refining the application strategy.
- Meeting outcomes do not constitute formal approval or guarantee acceptance.
- Significant changes after the meeting may require follow-up engagement.
- Sponsors remain fully responsible for the accuracy and completeness of eventual submissions.
The TGA provides detailed guidance on meeting types, request templates, briefing package expectations, prioritisation criteria, and examples of appropriate questions in the official page on medical device regulatory engagement meetings. Source: Medical device regulatory engagement meetings - TGA
These meetings promote collaborative regulatory engagement and help streamline the path to market for safe and effective medical devices in Australia.
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