The Therapeutic Goods Administration (TGA) has released Version 3.0 of its user guide, effective from March 2025, "Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles" providing detailed instructions on how to complete and submit applications for consent to import, supply, or export medical devices that do not meet the Essential Principles (EPs). This updated guidance covers the application process through the TGA Business Services (TBS) portal and introduces modernized features for better tracking and management of applications.
Essential Principles (EPs): The safety and performance requirements that medical devices must meet to be approved for import, supply, or export in Australia.
The guide applies to:
Devices already included in the ARTG that fail to meet EPs.
Devices under assessment for inclusion in the ARTG.
Exempt devices, including unapproved medical devices like therapeutic vaping devices.
The TGA may grant temporary consent for non-compliant devices under exceptional circumstances to prevent supply chain disruptions or address urgent medical needs.
Application Process Overview
Applicants must follow these steps to submit a consent application:
Access the TBS Portal: Log in to the TGA Business Services (TBS) portal and navigate to the "Consent for Non-Compliance Dashboard."
Start a New Application: Provide details of the device and select the applicable application type.
Provide Device Information: Enter information on the device manufacturer, device groupings, and the reason for non-compliance.
Submit Supporting Documents: Upload necessary files, including certificates and declarations.
Pay Fees: Fees are calculated based on the number of ARTG entries or devices under application.
Applicants can track and manage the progress of their submissions using the TBS portal.
The TGA applies a flat fee per ARTG entry or device application. Discounts are available under specific conditions, particularly for applications involving EP 13 (labeling) and EP 13A (patient information materials).
Fees can be paid via:
Immediate Payment: Through the TGA’s online payment system using a Client ID and application reference number.
Payment Against Invoice: TGA generates an invoice upon submission.
Sponsors can create groups of devices that share the same proposed consent period and implementation plan. This streamlined grouping method reduces administrative burden for sponsors submitting multiple devices.
Devices in the ARTG: Include existing products.
Devices Under Assessment: Devices pending approval in the ARTG.
Exempt Devices: Unapproved devices like therapeutic vaping devices.
Each device group requires detailed information on compliance gaps, implementation plans, and proposed consent periods.
Post-Submission Process
Once submitted, applications undergo the following stages:
Review: The TGA assesses the justification for non-compliance.
Approval or Rejection: Applicants are notified of the decision.
Monitoring: Approved consents are subject to regulatory oversight to ensure compliance progress.
Applicants can withdraw applications or respond to TGA queries directly through the TBS portal.
By following the structured procedures, applicants can ensure compliance with Australian regulations and minimize processing delays. For more detailed information, applicants are encouraged to consult the official TGA guide.
🔗 For full details, visit: TGA User Guide for Completing Applications
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