The Therapeutic Goods Administration (TGA) has released updated guidance in "Completing an application for consent to import, supply, or export medical devices that do not meet the Essential Principles (EPs)". This guidance outlines the application process, documentation requirements, processing fees, and compliance expectations for medical device sponsors in Australia.
The Essential Principles (EPs) set out by the TGA define the safety, quality, and performance requirements for medical devices in Australia. Non-compliance with EPs is a criminal offence under Section 41MA of the Therapeutic Goods Act 1989 unless explicit consent is granted by the TGA.
Consent is required if:
A medical device does not comply with one or more Essential Principles (EPs).
The device is included in the Australian Register of Therapeutic Goods (ARTG) or is part of an ARTG inclusion application.
Despite non-compliance, a sponsor seeks approval to import, supply, or export the device.
Sponsors must apply for consent even if their device is undergoing a regulatory variation process.
Application Process for Non-Compliant Medical Devices
A) Submission on TGA Business Services (TBS) Portal
Sponsors must submit the application via the TBS Portal under "Medical Device Post Market Compliance." The Consent for Non-Compliance Dashboard allows users to track submissions, view approvals, and manage notifications.
B) Required Documentation
Each application must include:
Completed Application Form (including ARTG number if applicable)
Declaration of Non-Compliance (indicating breached EPs)
Justification for Non-Compliance (with risk assessment)
Implementation Plan (to rectify non-compliance)
Approval from a Notified Body (if applicable)
Standard Processing Time: Varies based on device risk and application completeness. Consent is typically granted for a limited time (up to 3 years). If approval is revoked, the sponsor must cease importation and supply immediately.
A single application can cover multiple ARTG entries, provided all devices are non-compliant with the same EP(s). Devices can be grouped based on approval timelines and risk mitigation strategies. Fees apply per ARTG entry. Fee exemptions exist for devices transitioning from EU MDD/IVDD to MDR/IVDR certification (EP13). Payments can be made immediately after submission or via invoice request. Applications are only processed once full payment is received.
Sponsors must notify the TGA of any significant changes affecting the device’s compliance status. Devices under consent may be subject to post-market surveillance and audits. By following clear application guidelines and documentation requirements, sponsors can efficiently navigate the TGA approval system. For detailed guidance, visit: LINK
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