The Therapeutic Goods Administration (TGA) serves as Australia's regulatory authority for therapeutic goods, including medical devices and in-vitro diagnostic (IVD) devices. Its primary role is to ensure that these products meet stringent standards of safety, quality, and performance before they are made available to the public. A critical component of this regulatory framework is the application audit process, which evaluates whether devices submitted for inclusion in the Australian Register of Therapeutic Goods (ARTG) comply with legislative requirements. This article aims to inform medical device manufacturers about the latest updates to the TGA's application audit rules.

1. Background on TGA's Application Audit Process
   1. Definition and Purpose of Application Audits

TGA conducts application audits to ensure medical devices and IVDs meet legislative requirements before inclusion in the ARTG. These audits verify compliance with safety, performance, and quality standards. They fall into two categories:

• Mandatory Audits: Required for specific high-risk devices.
• Discretionary Audits: Conducted at the TGA's discretion based on potential concerns or insufficient information in the application.

2. Previous Audit Requirements

Prior to recent changes, the TGA's mandatory audit requirements applied to a broad scope of devices, notably including 'specified medical devices' within Class III and all Class 4 IVDs. For these devices, a TGA-issued Conformity Assessment Certificate was required as manufacturer evidence.

2. Recent Changes to Application Audit Rules
   1. Focus on High-Risk Devices

Effective 1 July 2024, the TGA has refined its application audit approach to concentrate mandatory audits on high-risk medical devices and IVDs. This strategic shift aims to streamline the audit process and allocate resources more efficiently, ensuring that regulatory efforts are focused where they are most needed.

2. Specific Applications Subject to Mandatory Audit

Under the updated rules, mandatory application audits are now limited to the following:

1. Class III Medical Devices supported by:
   • EU Medical Device Directive (MDD) certification.
   • Medical Device Single Audit Program (MDSAP) certification accompanied by U.S. Food and Drug Administration (FDA) 510(k) clearance.
2. IVD Medical Devices, including:
   • Class 3 and Class 4 IVDs.
   • IVDs intended for self-testing or point-of-care testing.
   • Class 4 in-house IVDs.

These applications must be supported by:

• • EU IVD Directive (IVDD) certification, including self-certification.
  • MDSAP certification, including those with U.S. FDA 510(k) clearance.

By narrowing the scope of mandatory audits to these categories, the TGA aims to focus its resources on devices that present the highest potential risks to patient safety.

3. Implications for Medical Device Manufacturers
   1. Compliance Requirements

Manufacturers of high-risk devices must ensure that their products meet the updated audit criteria. This involves preparing comprehensive documentation to support conformity assessments, including clinical evidence, risk management plans, and detailed device descriptions.

2.  Impact on Application Process

The refined focus on high-risk devices may lead to increased scrutiny during the application process for these categories. Manufacturers should prioritize the timely submission of accurate and complete information to avoid potential delays in ARTG inclusion.

4. Transition from EU IVDD to EU IVDR

The European Union In Vitro Diagnostic Medical Devices Directive (EU IVDD) is also being replaced by the new EU In Vitro Diagnostic Regulation (EU IVDR). This transition has significant implications for manufacturers supplying IVDs in Australia:

• Extended Transition Periods: On 24 April 2024, the EU extended the transition period, subject to eligibility conditions, until:
  • 31 December 2027 for Class D devices.
  • 31 December 2028 for Class C devices.
  • 31 December 2029 for Class B and Class A sterile devices.
• Enhanced Requirements: The EU IVDR introduces more stringent requirements to demonstrate IVD medical device safety, including:
  • Enhanced performance and clinical evidence requirements.
  • Additional quality management system obligations.
  • Changes to labeling and instructions for use.
  • Potential reclassification of devices based on intended purpose.

 

Sponsors and manufacturers must transition their ARTG entries to certification issued under the EU IVDR or another acceptable certification (e.g., MDSAP) to continue supplying these IVDs in Australia. The TGA will continue to accept EU IVDD evidence to support new IVD applications for inclusion in line with the EU transition periods when the sponsor provides evidence that the manufacturer meets the EU IVDR extension eligibility conditions.

 

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Reference:

1. Transitioning to new manufacturer evidence for in-vitro diagnostic medical devices (IVDs) 
2. Understanding application audit rules for medical devices including in-vitro diagnostics (IVDs)