TGA Pre-submission Meetings
The Therapeutic Goods Administration (TGA) in Australia encourages manufacturers or sponsors to engage in pre-submission meetings to streamline the regulatory submission process for medical devices, In-vitro diagnostic (IVD) devices, Combination devices, Complex therapeutic goods and new and emerging technologies.These meetings provide an opportunity for both to seek clarity on regulatory requirements, submission pathways, and technical issues.
What Are Pre-Submission Meetings with the TGA?
Pre-submission meetings are formal discussions between manufacturer or sponsors and the TGA held before submitting a device application. These meetings aim to clarify regulatory expectations, address potential concerns, and improve the quality and completeness of the submission.
Simplify your TGA pre-submission meeting process with our expert guidance. contact Freyr's specialists today to ensure your medical or IVD device aligns with regulatory requirements and secures timely approval in Australia.
How to Prepare for a Pre-Submission Meeting?
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Conduct Preliminary Research
Review TGA guidelines and standards and Understand device classification and regulatory pathways.
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Prepare a Pre-Submission Package
Provide detailed device descriptions, uses & claims and list key questions and areas needing clarification.
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Submit a Meeting Request
Complete the pre-submission meeting request form by clearly state the meeting purpose and discussion topics.
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Engage Subject Matter Experts
: Involve relevant regulatory, technical, or clinical experts.
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Follow Up Post-Meeting
Document meeting outcomes, action items and revise your submission dossier based on TGA feedback.
Freyr TGA Pre-submission Competencies
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TGA Medical Device Classification services![]()
TGA Medical Device Grouping and GMDN Code Assignment services![]()
Preparation of Technical File![]()
TGA Regulatory Submission Expertise![]()
Compliance with Australian Regulatory Pathways
Frequently Asked Questions
No, they are not mandatory. However, they are highly recommended for complex devices or when regulatory pathways are unclear, as they help reduce delays and improve submission quality.
The time to schedule a meeting may vary depending on the complexity of the request and the TGA’s availability. It is advisable to plan well in advance, allowing sufficient time to prepare and address TGA feedback.
The general process is similar, but IVD-specific meetings may involve additional discussions on analytical performance, clinical utility, and unique classification requirements for IVDs.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
TGA Pre-Submission Meetings Expertise and Advantages
- Guidance for pre-submission meetings across all device categories, including medical, IVD, combination devices, and SaMD.
- Analysis and review of device documentation for regulatory compliance.
- Evaluation and finalization of the appropriate regulatory pathway for TGA submissions.
- Preparation of detailed pre-submission meeting requests and supporting documents.
- Compilation of a comprehensive meeting package tailored to TGA expectations.
- Representation during TGA pre-submission meetings to address regulatory queries effectively.
- Post-meeting documentation, including action items and feedback integration into submission strategies.
- In-depth understanding of the TGA’s pre-submission meeting process and regulatory framework.
- Proven expertise in handling TGA submissions for a variety of device classifications.
- Tailored strategies to reduce submission delays and enhance dossier quality.
- Strong industry experience for seamless execution of pre-submission projects.
