Applying for TGA Conformity Assessment Certification for Medical Devices – Application Guide

Overview and Eligibility

TGA Conformity Assessment (CA) certification is mandatory for higher-risk medical devices (Class IIa, IIb, III, and certain IVDs) manufactured in Australia or by sponsors seeking direct TGA certification (rather than relying on EU notified body certificates under mutual recognition). Eligibility requires the applicant to be the manufacturer or authorised representative with access to full technical and quality documentation. Certification demonstrates compliance with relevant conformity assessment procedures in the Therapeutic Goods (Medical Devices) Regulations 2002. Source: Applying for conformity assessment certification - TGA

Key Requirements Before Application

• Device must be correctly classified per Schedule 2 rules.
• Quality Management System (QMS) must comply with ISO 13485 (or equivalent) and include Australian-specific requirements (e.g., complaint handling, adverse event reporting).
• Technical documentation must demonstrate compliance with all applicable Essential Principles (safety, performance, risk management).
• Clinical evidence required for higher classes (Class IIb implantable, Class III).
• Risk management file per ISO 14971.

Application Process Steps

1. Pre-submission Preparation

   • Gather all required documents (technical file, QMS procedures, test reports, clinical evaluation).
   • Decide on applicable modules (e.g., full QMS + design examination for Class III).

2. Submission via TGA Portal

   • Use TGA eBusiness Services portal.
   • Complete online application form.
   • Upload supporting documents (zipped if large).
   • Pay applicable fees.

3. Required Documentation

   • Manufacturer details and authorisation.
   • Device description, intended purpose, GMDN code.
   • Declaration of conformity (draft).
   • Technical documentation summary/index.
   • QMS certificates and procedures.
   • Evidence of compliance (bench testing, biocompatibility, sterility validation).
   • Clinical evidence summary/report.
   • Post-market surveillance plan.

4. Fees and Timelines

   • Application fees vary by class and modules (e.g., higher for Class III full assessment).
   • TGA acknowledges receipt within 5 working days.
   • Target processing: 30–150 working days (longer for complex or first-time applications).
   • Clock stops for information requests.

5. Assessment and Outcome

   • TGA reviews for completeness, then conducts technical and QMS evaluation.
   • May include on-site audit.
   • Successful applications result in issuance of TGA CA Certificate (valid for 5 years, subject to surveillance).
   • Unsuccessful applications receive detailed feedback.

Post-Certification Obligations

• Notify TGA of changes affecting certification.
• Maintain QMS and undergo periodic surveillance audits.
• Report adverse events and recalls.
• Use certificate to support ARTG inclusion application.

This certification pathway ensures rigorous pre-market evaluation for higher-risk devices in Australia. Full checklists, fee calculator, portal access instructions, and examples of acceptable evidence are provided in the official TGA guidance on applying for conformity assessment certification. Source: Applying for conformity assessment certification - TGA

The guide assists manufacturers in preparing complete applications and achieving timely certification.