TGA Conformity Assessment Certification Application Process – Step-by-Step Instructions

Purpose and Scope

This guidance outlines the process for manufacturers or authorised representatives to apply for TGA-issued Conformity Assessment (CA) certification under the Australian regulatory framework. CA certification demonstrates compliance with the conformity assessment procedures specified in the Therapeutic Goods (Medical Devices) Regulations 2002 and is required for higher-risk devices (Class IIa, IIb, III, and some IVDs) before ARTG inclusion. The TGA acts as a notified body equivalent for Australian manufacturers or those seeking TGA-specific certification. Source: Application instructions: Conformity assessment certification - TGA

Pre-Application Preparation

• Confirm device classification and required conformity assessment procedure (e.g., full quality assurance system + design/type examination for Class III).
• Ensure Quality Management System (QMS) complies with ISO 13485 or equivalent, including Australian-specific requirements.
• Prepare technical documentation demonstrating compliance with Essential Principles.
• Identify whether relying on EU notified body certification (MRA/MDSAP) or applying directly to TGA.
• Contact TGA for pre-submission advice if needed (especially for novel or high-risk devices).

Application Submission Requirements

• Submit via TGA e-Business Services portal.
• Include:
  • Completed application form
  • Device description and intended purpose
  • Technical documentation summary
  • QMS documentation (procedures, records)
  • Evidence of compliance (test reports, risk management file, clinical evidence)
  • Declaration of conformity (draft)
  • Fee payment
• For design/type examination modules: additional detailed design dossier.

Document Checklist Highlights

• Manufacturer information and authorisation
• Device nomenclature code (GMDN)
• Risk classification justification
• Labelling and IFU samples
• Post-market surveillance plan
• Clinical evaluation report (as applicable)

Fees and Processing Timelines

• Application fees vary by device class and procedure (e.g., higher for Class III full assessment).
• TGA aims to acknowledge receipt within 5 working days.
• Target processing times: 30–150 working days depending on class and complexity (longer for first-time applicants or complex devices).
• Clock stops may occur for requests for additional information.

Assessment Process

• TGA reviews documentation for completeness and compliance.
• May conduct on-site audits of manufacturing facilities.
• Technical experts evaluate safety, performance, and benefit-risk.
• Successful assessment results in issuance of TGA Conformity Assessment Certificate.

Post-Certification Obligations

• Maintain QMS compliance and notify TGA of significant changes.
• Report adverse events and field safety issues.
• Renew certification as required (typically aligned with ISO 13485 surveillance).
• Use certificate to support ARTG inclusion application.

This process ensures rigorous pre-market evaluation for higher-risk medical devices in Australia. Detailed forms, fee schedules, checklists, and examples of acceptable documentation are provided in the official TGA application instructions for conformity assessment certification. Source: Application instructions: Conformity assessment certification - TGA

The guidance supports manufacturers in achieving compliant market access while maintaining high safety standards.