Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 10, 2026
Approximately 5 minutes
Essential Principles Consent for Non-Compliant Medical Devices – TGA Transitional Arrangements
Essential Principles Consent for Non-Compliant Medical Devices – TGA Transitional Arrangements
Background and Policy Context
The Therapeutic Goods Administration (TGA) introduced transitional arrangements to support the implementation of the European Union Medical Device Regulation (EU MDR) and address supply continuity challenges. For certain medical devices that held valid certification under the previous EU Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) but do not fully comply with the updated Australian Essential Principles (aligned with EU MDR changes), the TGA may grant consent to supply under section 41HB of the Therapeutic Goods Act 1989. This consent mechanism is part of broader reforms to harmonise with international standards while protecting Australian public health. Source: Essential Principles consent for non-compliance - TGA
Eligibility for Essential Principles Consent
Consent may be granted if the device meets all of the following criteria:
- Holds a valid certificate issued under the EU MDD or AIMDD by a notified body (pre-EU MDR certificates).
- The certificate remains valid during the transition period (extended validity under EU MDR Article 120 transitional provisions).
- The device is not subject to serious safety concerns or restrictions.
- Supply is necessary to avoid shortages or significant disruption in Australia.
- The manufacturer/sponsor provides evidence that the device continues to meet essential safety and performance requirements despite non-compliance with updated Essential Principles.
Application Process for Consent
- Submit a formal application to the TGA via the eBusiness Services portal.
- Include:
- Copy of the valid EU MDD/AIMDD certificate.
- Technical documentation demonstrating ongoing compliance with core safety/performance aspects.
- Risk assessment addressing any non-compliance with updated Essential Principles.
- Supply shortage justification and impact analysis.
- Post-market surveillance plan and commitment to report adverse events.
- TGA assesses applications case-by-case, considering public health need and risk-benefit profile.
Conditions and Limitations
- Consent is time-limited and typically tied to the EU transitional validity period.
- The device must continue to comply with labelling, advertising, and reporting obligations.
- Sponsors must monitor for emerging risks and notify TGA of any changes.
- Consent does not constitute full regulatory approval; it is a temporary exemption.
- TGA may impose additional conditions (e.g., enhanced monitoring, restricted distribution).
Practical Implications
This consent pathway primarily benefits legacy devices transitioning from MDD/AIMDD certification, allowing continued supply while manufacturers work toward full EU MDR compliance and subsequent alignment with Australian Essential Principles. It reflects TGA’s risk-proportionate approach during global regulatory transitions.
Detailed eligibility checklists, application templates, examples of acceptable evidence, and updates on transitional periods are provided in the official TGA guidance on Essential Principles consent for non-compliance. Source: Essential Principles consent for non-compliance - TGA
The arrangements support supply stability without compromising core patient safety requirements.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Quality Management Systems for Medical Devices – TGA Requirements and Guidance
The Therapeutic Goods Administration (TGA) requires manufacturers of medical devices to implement and maintain a Quality Management System (QMS) that complies with ISO 13485:2016 (or equivalent) to ensure consistent quality, safety, and performance. This includes risk management, design controls, production processes, and post-market surveillance, with evidence of compliance needed for conformity assessment and ARTG inclusion, particularly for higher-risk classes.
Approximately 5 minutes
Manufacturing Medical Devices and IVDs in Australia – TGA Regulatory Requirements
The Therapeutic Goods Administration (TGA) regulates the manufacture of medical devices and in vitro diagnostic (IVD) medical devices to ensure consistent production of safe and effective products that comply with the Essential Principles. Manufacturers must implement a quality management system aligned with ISO 13485, demonstrate GMP compliance (with mandatory audits for higher classes), maintain traceability, and fulfil ongoing post-market obligations under the Therapeutic Goods Act 1989 and Medical Devices Regulations 2002.
Approximately 5 minutes
Quality Management System Audits and Certification for Medical Devices – TGA Guidance
The Therapeutic Goods Administration (TGA) provides detailed guidance on the audits and certification of Quality Management Systems (QMS) for medical devices, focusing on ISO 13485 compliance evidence, acceptable certification bodies, audit processes (including surveillance and initial audits), timelines, and ongoing obligations to support conformity assessment applications and maintain regulatory compliance in Australia.