Steps for Manufacturers to Supply Medical Devices in Australia – TGA Guide

Step 1: Classify the Device

• Determine risk-based classification (Class I, Is, Im, IIa, IIb, III) per Therapeutic Goods (Medical Devices) Regulations.
• Use rules in Schedule 2 of the regulations (e.g., invasive, active, implantable).
• Higher classes require more stringent evidence and conformity assessment.

Step 2: Choose Conformity Assessment Procedure

• Select appropriate procedure based on classification:
  • Class I (non-sterile, non-measuring): Self-declaration possible.
  • Higher classes: Involve conformity assessment body (Australian or overseas recognised).
• Options include full quality assurance, type examination, production quality assurance.
• Demonstrate compliance with Essential Principles (safety and performance).

Step 3: Prepare Technical Documentation

• Compile comprehensive file including:
  • Device description and intended purpose.
  • Design and manufacturing information.
  • Risk management file.
  • Clinical evidence (where required).
  • Labelling, instructions for use, and promotional material.
• Maintain documentation for inspection and post-market needs.

Step 4: Appoint Australian Sponsor (if overseas manufacturer)

• Non-Australian manufacturers must appoint an Australian sponsor.
• Sponsor handles regulatory interactions, ARTG application, and post-market responsibilities.
• Sponsor must be an Australian entity or resident.

Step 5: Apply for Inclusion in the ARTG

• Submit application via TGA Business Services portal.
• Include conformity assessment evidence, Declaration of Conformity, and technical summary.
• Pay applicable fees.
• TGA assesses application; processing times vary by class and complexity.

Step 6: Supply After ARTG Inclusion

• Once included, device can be lawfully supplied.
• Ensure labelling includes ARTG number and sponsor details.
• Comply with advertising restrictions and post-market vigilance.

Ongoing Obligations

• Report adverse events and incidents promptly.
• Conduct post-market surveillance.
• Notify TGA of changes requiring variation.
• Cooperate with recalls or corrections if needed.

Detailed classification rules, conformity assessment options, documentation checklists, sponsor requirements, application forms, fees, and timelines are provided in the TGA guide on steps to supply a medical device for manufacturers. Source: Steps to supply a medical device (for manufacturers) - TGA

This pathway ensures only safe and effective medical devices reach the Australian market while supporting manufacturer compliance.